Chronic Hepatitis CPhase 2NCT02569710

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir

A Phase 2 study testing AL-335, Odalasvir (ODV) and Simeprevir (SMV) in people with Chronic Hepatitis C, run by Alios Biopharma Inc. at 11 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Hepatitis C
What is being tested?: AL-335, Odalasvir (ODV) and Simeprevir (SMV)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 11 sitesin 4 countries
Study dates: 31 Oct 2015to 11 May 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has provided written consent
In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned
Male or female, 18-70 years of age
Body mass index (BMI) 18-35 kilogram per meter square (kg/m^2), inclusive
A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening
Female participants must either:

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not be of childbearing potential defined as: i. Postmenopausal for at least 12 months (that is [i.e.], 2 years of amenorrhea without an alternative medical cause) and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (per reference laboratory), OR ii. Surgically sterile (example [e.g.], underwent total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant, OR
be of childbearing potential AND
not heterosexually active (e.g., abstinent or homosexual) from screening until 6 months after study drug administration (or longer, if dictated by local regulations), OR
if heterosexually active
have a vasectomized partner (confirmed sterile per verbal account of the participant), OR
using an acceptable method of birth control from screening and agree to continue to use the same method of contraception throughout the study and for 6 months after study drug administration (or longer, if dictated by local regulations). Oral hormone based contraceptives are not allowed from 14 days before the planned study drug administration until 6 months after the last dose of treatment due to the potential for drug-drug interactions which might undermine their efficacy. An intrauterine device (IUD), being either hormonal (i.e., Intra-Uterine System [IUS*]) or non-hormonal, is considered highly effective and reliable; therefore participants using an IUD/IUS are not required to use additional contraceptive methods (no double-barrier method is required). Other non-oral hormone-based contraception methods (e.g., injectable, implants, transdermal system, vaginal ring) may be continued, but as the interaction of the study drug with hormone-based contraception is unknown, these methods are not considered to be reliable and therefore participants should use a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide).
An IUS does not rely on systemic plasma concentrations and is therefore not expected to be impacted by a potential drug-drug interaction (DDI)
Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction
A post-menopausal female who is receiving hormone replacement therapy and is willing to discontinue hormone therapy 30 days before study drug dosing and agrees to remain off hormone replacement therapy for the duration of the study may be eligible for study participation.
Male participants must either:
be surgically sterile (had a vasectomy), or otherwise incapable of fathering a child, OR
not be heterosexually active (e.g., abstinent or homosexual) from enrollment (Day 1) in the study until at least 6 months after study drug administration, OR
if heterosexually active:
have a partner who is postmenopausal (2 years amenorrhea), surgically sterile (e.g., has had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant OR
be practicing an acceptable method of birth control from enrollment in the study (Day 1) and agree to continue to use the same method of contraception throughout the study and for at least 6 months after study drug administration (or longer, if dictated by local regulations). An acceptable method of birth control for male participants is a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide).
Note: Male participants with a female partner who uses hormonal contraceptives (oral, injectable, implants) or a hormonal (IUS) or non-hormonal IUD and male participants who are vasectomized or otherwise incapable of fathering a child are not required to use additional contraceptive methods.
Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
NOTE: Contraceptive use by men and women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria
Participants must agree to refrain from sperm/egg donation from start of dosing through 6 months after the completion of study drug administration
Genotype (GT) 1a or 1b or GT2 or 3 chronic hepatitis C (CHC), depending on cohort, with positive Hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA) at screening including documentation of CHC infection for at least 6 months. Genotype testing must occur at a screening visit. NOTE: GT1 patients are eligible for inclusion even if they cannot be successfully subtyped unless a specific subtype is required for a cohort
Screening HCV RNA viral load greater than or equal to (>=) 50,000 International Units per milliliter (IU/mL), except for participants with compensated cirrhosis (Child Pugh Class A) who may have HCV RNA viral load >=10^4 IU/mL
No prior treatment for CHC (defined as no prior exposure to any approved or investigational drug including direct-acting antivirals, and interferon-based treatments)
Fibroscan, collected within 6 months of baseline visit, with liver stiffness score less than or equal to (<=) 12.5 kilo Pascal (kPa) to be eligible (except for participants with cirrhosis, see below).
participants with compensated cirrhosis must meet the Child-Pugh Class A definition (see Appendix G) and at least one of the following criteria: i. Liver biopsy result indicating the presence of cirrhosis (e.g., Metavir F4; Ishak >5) or ii. Fibroscan evaluation with a liver stiffness score >12.5 kPa
Participant is otherwise in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECG)
Willing to avoid prolonged sun exposure and use of tanning devices while taking Simeprevir (SMV) and through 4 weeks of follow up. Participant should also be advised to use a broad-spectrum sunscreen and lip balm of at least sun protection factor >30 to help protect against potential sunburn

Who cannot join

Pregnant, planning on becoming pregnant (during treatment and up to 6 months after the end of treatment [EOT]), or breast-feeding female participant, or male participant whose female partner is pregnant or planning on becoming pregnant (during treatment and up to 6 months after the EOT)
Other than CHC with or without compensated cirrhosis, clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid or any other medical illness or psychiatric disorder, as determined by the Investigator and/or Sponsor's Medical Monitor
History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant ECG abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening
Screening echocardiogram ejection fraction <55 percentage (%) or any other echocardiographic finding suggestive of clinically relevant cardiomyopathy
Creatinine clearance of <60 mL/min (Cockcroft-Gault)
Positive test for Hepatitis A virus immunoglobulin (HAV) Immunoglobulin M (IgM), Hepatitis B surface antigen (HBsAg), or Human Immunodeficiency Virus (HIV) Ab

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Abnormal screening laboratory results that are considered clinically significant by the investigator
History of clinical hepatic decompensation, e.g., variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy or active jaundice (within last year)
Any condition that, in the opinion of the investigator, would compromise the study's objectives or the well-being of the participant or prevent the participant from meeting the study requirements
Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to study medication
Clinically significant abnormal screening ECG findings (e.g., PR >200 msec, QRS interval >120 millisecond (msec) or corrected QT interval (QTc) >450 msec for male participants and >470 msec for female participants), based on an average of triplicate ECGs. Any evidence of heart block or bundle branch block is also exclusionary
History or family history of abnormal ECG intervals, for example prolonged QT syndrome (torsade de pointes) or sudden cardiac death
The participant has a positive prestudy drug screen, including methadone unless the drug is prescribed by the participant's physician. The list of drugs that should be screened for includes amphetamines, barbiturates, cocaine, opiates, phencyclidine (PCP), and benzodiazepines
Laboratory abnormalities including:
Hematocrit <0.34
White blood cell counts <3,500/millimeter (mm)^3 (<1,000/mm^3 for participants with compensated cirrhosis)
Absolute neutrophil count <1,000/mm^3 (<750/mm^3 for participants with compensated cirrhosis)
Platelets <=120,000/mm^3 (platelets ≤90,000/mm^3 for participants with compensated cirrhosis)
Glycosylated hemoglobin (HbA1C) >55 mmol/mol
Prothrombin time >=1.5 * upper limit of normal (ULN)
Albumin <=32 gram per liter (g/L), bilirubin >=1.5 milligram per deciliter (mg/dL) at screening (participants with documented Gilbert's disease allowed)
Serum ALT concentration >=5* ULN
CK >1.5* ULN A single repeat laboratory evaluation under appropriate conditions (e.g., fasted, no antecedent exercise) is allowed for eligibility determination
Any condition possibly affecting drug absorption (e.g., gastrectomy or other significant gastrointestinal tract surgery, such as gastroenterostomy, small bowel resection, or active enterostomy)
Clinically significant blood loss or elective blood donation of significant volume (i.e., >500 mL) within 60 days of first dose of study drug; >1 unit of plasma within 7 days of first dose of study drug
Evidence of clinically relevant active infection that would interfere with study conduct or its interpretation
History of regular alcohol intake >10 standard drinks per week of alcohol for females and >15 standard drinks per week for males (one unit is defined as 10 g alcohol) within 3 months of the screening visit
The use of prohibited medications, including prescription, over the counter (OTC) medications, herbal medications, inducers or inhibitors of Cytochrome P450 (CYP450) enzymes or drug transporters (including P-gp) within 14 days prior to the first dose of study medication is excluded, unless previously approved by the Sponsor's Medical Monitor. NOTE: Chronic medication use is permitted so long as they are medically necessary, deemed acceptable by the Principal Investigator and Medical Monitor, and not Prohibited Medications (see Section 5.12)
Hypersensitivity to the active substances (including sulfa allergy) or to any of the excipients of AL-335, Odalasvir (ODV) or SMV
Evidence on recent (within 6 months) liver ultrasound of hepatic mass or lesion concerning for malignancy (participants with cirrhosis only)

Trial locations and contacts

11 sites in 4 countries.

Country

City, postcode or hospital

11 sites in 4 countries

New Zealand6 sites

Auckland Clinical Studies
Auckland, 1150
Christchurch Clinical Studies Trust
Christchurch, 8011
Waikato Hospital
Hamilton
P3 Research Ltd - Hawkes Bay
Havelock North
P3 Research Ltd - Wellington
Wellington
Wellington Hospital
Wellington

Other trials in New Zealand

United Kingdom3 sites

King's College Hospital
Brixton
NHS Greater Glasgow and Clyde Glasgow Royal Infirmary
Glasgow
Pennine Acute Hospitals Trust
Oldham

Other trials in United Kingdom

Mauritius1 site

CAP Research Ltd
Phoenix

Other trials in Mauritius

Moldova1 site

Republican Clinical Hospital
Chisinau

Other trials in Moldova

About this study

Official title: A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, With or Without Simeprevir, in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Infection With or Without Compensated Child Pugh A Cirrhosis

Conditions: Chronic Hepatitis C
Being tested: AL-335, Odalasvir (ODV), Simeprevir (SMV)
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AL-335Drug
AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).
Odalasvir (ODV)Drug
Also called ACH-3102
ODV capsules will be administered in a dose range of 25 to 50 mg.
Simeprevir (SMV)Drug
SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).

Study groups in NCT02569710
Study group	Role	What they receive
Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV	Experimental	Treatment-naïve non-cirrhotic Hepatitis C virus (HCV)-infected participants will receive AL-335 and Odalasvir (ODV) with Simeprevir (SMV) for 8 weeks. Receives: Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)
Cohort 1b (Without Cirrhosis) : AL-335+ODV	Experimental	Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV for 8 weeks. Receives: Drug: AL-335; Drug: Odalasvir (ODV)
Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV	Experimental	Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV with SMV for 6 weeks. Receives: Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)
Cohort 4 (Without Cirrhosis) : AL-335+ODV	Experimental	Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV up to 8 or 12 weeks. Receives: Drug: AL-335; Drug: Odalasvir (ODV)
Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV	Experimental	Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV with SMV up to 8 or 12 weeks. Receives: Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)
Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV	Experimental	Treatment naïve or treatment experienced HCV-infected participants with compensated cirrhosis will receive AL-335 and ODV with SMV for 8 weeks. Receives: Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)
Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV	Experimental	Treatment naïve or treatment experienced HCV-infected participants with compensated cirrhosis will receive AL-335 and ODV with SMV for 12 weeks. Receives: Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)
Cohorts 12 to 15: AL-335+ODV With/without SMV	Experimental	Based on safety, pharmacokinetic (PK), and viral load data, the treatment duration (4 to 12 weeks) and dose levels (AL-335: 400-1,200 milligram [mg], ODV: 25-50 mg with/without SMV: 75-150 mg) may be changed for ongoing and future cohorts (up to 15) after obtaining agreement from the Sponsor and the Principal Investigator. Receives: Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Up to 43 weeks
Body Weight at End of Treatment
Body weight (measured using a calibrated scale) at end of treatment was reported.
Measured: End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Body Mass Index (BMI) at End of Treatment
BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported.
Measured: End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
Percentage of participants with worst post-baseline values of vital signs (Systolic blood pressure [sBP], Diastolic blood pressure [dBP], and Heart rate) were reported. For sBP, abnormally low: less than or equal to [<=] 90 millimeters mercury [mmHg]; Grade 1 or mild: greater than [>] 140 to less than [<] 160 mmHg; Grade 2 or moderate: >=160 to <180 and Grade 3 or severe: >=180 mmHg. For dBP, abnormally low: <=50 mmHg; Grade 1 or mild: >90 to <100 mmHg; Grade 2 or moderate: >=100 to <110 mmHg and Grade 3 or severe: >=110 mmHg. For Heart Rate, abnormally low: <=50 beats per minute [bpm] and abnormally high: >=120 bpm.
Measured: Up to 43 weeks
Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
Percentage of participants with maximum decrease from baseline in mean ejection fraction was reported. Percentages are based on the number of participants with available data.
Measured: Baseline up to End of treatment (up to 43 weeks)
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Percentage of participants by treatment emergent toxicity grade (1, 2, 3, 4 and 3+4) for Hematology parameters (hemoglobin, lymphocytes, neutrophils, leukocytes, platelets) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Measured: Up to 43 weeks
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Percentage of participants by treatment emergent toxicity grade (Grade 1,2,3,4,3+4) for Blood Chemistry (Calcium, Phosphate, Potassium, Sodium, Bicarbonate, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Direct bilirubin, Glucose, Cholesterol, Triglycerides, Urate, Triacylglycerol lipase, Creatinine, Creatinine clearance, Albumin and Creatine kinase) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Measured: Up to 43 weeks
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Percentage of participants by treatment emergent toxicity grade for coagulation parameter (Prothrombin International Normalized Ratio) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Measured: Up to 43 weeks
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Percentage of participants by treatment emergent toxicity grade (Grade 1, 2, 3, 4, 3+4) for urinalysis parameter (protein) was reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Measured: Up to 43 weeks
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
Percentage of participants with worst treatment emergent abnormalities of ECG parameters (Fridericia Corrected QT interval [QTcF], Bazett Corrected QT interval [QTcB], Heart rate, QRS and PR, was reported. For QTcF abnormality was defined as 30 milliseconds (ms) less than or equal to (<=) QTcF increase from baseline <= 60 ms; for QTcB abnormality was defined as 30 ms <= QTcB increase from baseline <= 60 ms; for heart rate - abnormal low: <= 50 beats per minute (bpm) and abnormal high: >= 120 bpm; for QRS - abnormal high: >120 ms; for PR - abnormally low: PR < 120 ms; abnormally high - 200 ms < PR <= 240 ms and 240 ms < PR <= 300 ms.
Measured: Up to 43 weeks

Secondary outcomes (34)

Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment
Participants were considered to have achieved SVR if the Hepatitis C virus (HCV) Ribonucleic acid (RNA) less than (<) Lower limit of quantification (LLOQ) (<15 international unit per milliliter [IU/mL]) detectable or undetectable at Week 4, 12 and 24 after the actual end of study drug treatment.
Measured: At Week 4, 12 and Week 24 after end of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Cmin is the minimum observed plasma concentration of AL-335 and its metabolites (ALS-022399 and ALS-022227). For Pharmacokinetic (PK) analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Cmax is the maximum observed plasma concentration of AL-335 and its metabolites (ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Ctrough is the trough plasma concentration for AL-335 and its metabolites (ALS-022399 and ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Tmax is the time to reach the maximum plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)
Clast is the last measurable plasma concentration (Clast) of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Tlast is the time corresponding to last measurable plasma concentration for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227
Css,avg is the average plasma concentration at steady state of ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmin of Simeprevir
Cmin is the minimum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmax of Simeprevir
Cmax is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Ctrough of Simeprevir
Ctrough is the trough plasma concentration of Simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tmax of Simeprevir
Tmax is the Time to reach the maximum plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-last) of Simeprevir
AUC (0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-24) of Simeprevir
AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Clast of Simeprevir
Clast is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tlast of Simeprevir
Tlast is the time corresponding to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir
Css,avg is the average plasma concentration at steady state of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmin of Odalasvir
Cmin is the minimum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmax of Odalasvir
Cmax is the maximum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Ctrough of Odalasvir
Ctrough is the trough plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tmax of Odalasvir
Tmax is the time to reach the maximum plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-last) of Odalasvir
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-24) for Odalasvir
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Clast of Odalasvir
Clast is the last measurable plasma concentration (Clast) of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tlast of Odalasvir
Tlast is the time corresponding to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir
Css,avg is the average plasma concentration at steady state of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Percentage of Participants With Virologic Relapse During the Follow-up Period
Viral relapse is defined as participants SVR12, with HCV RNA <LLOQ at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow up.
Measured: Follow up period (Up to Week 12 after end of treatment)
Percentage of Participants With On-treatment Failure
On-treatment failure was defined by participants who did not achieve SVR12 and with confirmed HCV RNA >= LLOQ at the actual end of study drug treatment.
Measured: Up to 12 weeks
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Percentage of participants who achieved HCV RNA less then (<) LLOQ undetectable was reported.
Measured: Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Percentage of Participants Who Achieved HCV RNA <LLOQ
Percentage of participants who achieved HCV RNA <LLOQ was reported.
Measured: Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA
Time to achieve undetectable HCV RNA or < LLOQ HCV RNA was reported.
Measured: Up to Week 24 (follow up visit)
Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure
Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants with virologic failure.
Measured: Up to Week 24 (Follow up visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 201511 May 2018

First posted7 Oct 2015 (estimated)
Study start31 Oct 2015
Primary completion11 May 2018
Study completion11 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02569710
Sponsor's protocol ID: AL-335-604
Status last verified: Jun 2019
First submitted: 1 Oct 2015
Last updated: 16 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of Patients With Liver Disease
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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, With or Without Simeprevir, in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Infection With or Without Compensated Child Pugh A Cirrhosis
ClinicalTrials.gov ID: NCT02569710
Acronym / sponsor ID: AL-335-604
Conditions: Chronic Hepatitis C
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Alios Biopharma Inc.Industry (pharma, biotech, devices)
Study start: 31 Oct 2015 (actual)
Primary completion: 11 May 2018 (actual)
Study completion: 11 May 2018 (actual)
First posted: 7 Oct 2015 (estimated)
Results: Posted 16 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV	Experimental	Drug: AL-335, Drug: Odalasvir (ODV), Drug: Simeprevir (SMV)Treatment-naïve non-cirrhotic Hepatitis C virus (HCV)-infected participants will receive AL-335 and Odalasvir (ODV) with Simeprevir (SMV) for 8 weeks.
Cohort 1b (Without Cirrhosis) : AL-335+ODV	Experimental	Drug: AL-335, Drug: Odalasvir (ODV)Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV for 8 weeks.
Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV	Experimental	Drug: AL-335, Drug: Odalasvir (ODV), Drug: Simeprevir (SMV)Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV with SMV for 6 weeks.
Cohort 4 (Without Cirrhosis) : AL-335+ODV	Experimental	Drug: AL-335, Drug: Odalasvir (ODV)Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV up to 8 or 12 weeks.
Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV	Experimental	Drug: AL-335, Drug: Odalasvir (ODV), Drug: Simeprevir (SMV)Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV with SMV up to 8 or 12 weeks.
Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV	Experimental	Drug: AL-335, Drug: Odalasvir (ODV), Drug: Simeprevir (SMV)Treatment naïve or treatment experienced HCV-infected participants with compensated cirrhosis will receive AL-335 and ODV with SMV for 8 weeks.
Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV	Experimental	Drug: AL-335, Drug: Odalasvir (ODV), Drug: Simeprevir (SMV)Treatment naïve or treatment experienced HCV-infected participants with compensated cirrhosis will receive AL-335 and ODV with SMV for 12 weeks.
Cohorts 12 to 15: AL-335+ODV With/without SMV	Experimental	Drug: AL-335, Drug: Odalasvir (ODV), Drug: Simeprevir (SMV)Based on safety, pharmacokinetic (PK), and viral load data, the treatment duration (4 to 12 weeks) and dose levels (AL-335: 400-1,200 milligram [mg], ODV: 25-50 mg with/without SMV: 75-150 mg) may be changed for ongoing and future cohorts (up to 15) after obtaining agreement from the Sponsor and the Principal Investigator.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (34 listed)

Participant has provided written consent
In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned
Male or female, 18-70 years of age
Body mass index (BMI) 18-35 kilogram per meter square (kg/m^2), inclusive
A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening

Key exclusion criteria (30 listed)

Pregnant, planning on becoming pregnant (during treatment and up to 6 months after the end of treatment [EOT]), or breast-feeding female participant, or male participant whose female partner is pregnant or planning on becoming pregnant (during treatment and up to 6 months after the EOT)
Other than CHC with or without compensated cirrhosis, clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid or any other medical illness or psychiatric disorder, as determined by the Investigator and/or Sponsor's Medical Monitor
History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant ECG abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening
Screening echocardiogram ejection fraction <55 percentage (%) or any other echocardiographic finding suggestive of clinically relevant cardiomyopathy
Creatinine clearance of <60 mL/min (Cockcroft-Gault)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AL-335AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).	Drug	Cohort 1b (Without Cirrhosis) : AL-335+ODV, Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV, Cohort 4 (Without Cirrhosis) : AL-335+ODV, Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV, Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV, Cohorts 12 to 15: AL-335+ODV With/without SMV, Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV, Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV
Odalasvir (ODV)Also: ACH-3102ODV capsules will be administered in a dose range of 25 to 50 mg.	Drug	Cohort 1b (Without Cirrhosis) : AL-335+ODV, Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV, Cohort 4 (Without Cirrhosis) : AL-335+ODV, Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV, Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV, Cohorts 12 to 15: AL-335+ODV With/without SMV, Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV, Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV
Simeprevir (SMV)SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).	Drug	Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV, Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV, Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV, Cohorts 12 to 15: AL-335+ODV With/without SMV, Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV, Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV

Primary outcome

Number of Participants With Treatment Emergent Adverse Event (TEAE)
Time frame: Up to 43 weeks
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state.
Body Weight at End of Treatment
Time frame: End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Body weight (measured using a calibrated scale) at end of treatment was reported.
Body Mass Index (BMI) at End of Treatment
Time frame: End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported.
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
Time frame: Up to 43 weeks
Percentage of participants with worst post-baseline values of vital signs (Systolic blood pressure [sBP], Diastolic blood pressure [dBP], and Heart rate) were reported. For sBP, abnormally low: less than or equal to [<=] 90 millimeters mercury [mmHg]; Grade 1 or mild: greater than [>] 140 to less than [<] 160 mmHg; Grade 2 or moderate: >=160 to <180 and Grade 3 or severe: >=180 mmHg. For dBP, abnormally low: <=50 mmHg; Grade 1 or mild: >90 to <100 mmHg; Grade 2 or moderate: >=100 to <110 mmHg and Grade 3 or severe: >=110 mmHg. For Heart Rate, abnormally low: <=50 beats per minute [bpm] and abnormally high: >=120 bpm.
Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
Time frame: Baseline up to End of treatment (up to 43 weeks)
Percentage of participants with maximum decrease from baseline in mean ejection fraction was reported. Percentages are based on the number of participants with available data.
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Time frame: Up to 43 weeks
Percentage of participants by treatment emergent toxicity grade (1, 2, 3, 4 and 3+4) for Hematology parameters (hemoglobin, lymphocytes, neutrophils, leukocytes, platelets) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Time frame: Up to 43 weeks
Percentage of participants by treatment emergent toxicity grade (Grade 1,2,3,4,3+4) for Blood Chemistry (Calcium, Phosphate, Potassium, Sodium, Bicarbonate, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Direct bilirubin, Glucose, Cholesterol, Triglycerides, Urate, Triacylglycerol lipase, Creatinine, Creatinine clearance, Albumin and Creatine kinase) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Time frame: Up to 43 weeks
Percentage of participants by treatment emergent toxicity grade for coagulation parameter (Prothrombin International Normalized Ratio) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Time frame: Up to 43 weeks
Percentage of participants by treatment emergent toxicity grade (Grade 1, 2, 3, 4, 3+4) for urinalysis parameter (protein) was reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
Time frame: Up to 43 weeks
Percentage of participants with worst treatment emergent abnormalities of ECG parameters (Fridericia Corrected QT interval [QTcF], Bazett Corrected QT interval [QTcB], Heart rate, QRS and PR, was reported. For QTcF abnormality was defined as 30 milliseconds (ms) less than or equal to (<=) QTcF increase from baseline <= 60 ms; for QTcB abnormality was defined as 30 ms <= QTcB increase from baseline <= 60 ms; for heart rate - abnormal low: <= 50 beats per minute (bpm) and abnormal high: >= 120 bpm; for QRS - abnormal high: >120 ms; for PR - abnormally low: PR < 120 ms; abnormally high - 200 ms < PR <= 240 ms and 240 ms < PR <= 300 ms.

34 secondary outcomes

Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment
Time frame: At Week 4, 12 and Week 24 after end of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmin of Simeprevir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmax of Simeprevir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Ctrough of Simeprevir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tmax of Simeprevir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-last) of Simeprevir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-24) of Simeprevir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Clast of Simeprevir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tlast of Simeprevir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmin of Odalasvir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmax of Odalasvir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Ctrough of Odalasvir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tmax of Odalasvir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-last) of Odalasvir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-24) for Odalasvir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose
Clast of Odalasvir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tlast of Odalasvir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Percentage of Participants With Virologic Relapse During the Follow-up Period
Time frame: Follow up period (Up to Week 12 after end of treatment)
Percentage of Participants With On-treatment Failure
Time frame: Up to 12 weeks
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Time frame: Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Percentage of Participants Who Achieved HCV RNA <LLOQ
Time frame: Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA
Time frame: Up to Week 24 (follow up visit)
Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure
Time frame: Up to Week 24 (Follow up visit)

Results and safety

Results posted to the registry on 16 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (8 Weeks Genotype [GT1])	20	19
Cohort 1b + Cohort 4 (8 Weeks GT1)	25	25
Cohort 2 (8 Weeks GT1)	20	20
Cohort 3 (6 Weeks GT1)	20	20
Cohort 4 (12 Weeks GT1)	8	7
Cohort 5a (8 Weeks GT3)	5	4
Cohort 5b (12 Weeks GT3)	14	12
Cohort 6,7,8 (8 Weeks GT1 F4)	30	30
Cohort 9 (12 Weeks GT1 F4)	15	14
Cohort 11 (12 Weeks GT2 F4)	4	4

Primary outcome: Number of Participants With Treatment Emergent Adverse Event (TEAE)

Time frame: Up to 43 weeks. Count of participants. Unit: Participants

Measure	Cohort 1 (8 Weeks Genotype [GT1]) n = 20	Cohort 1b + Cohort 4 (8 Weeks GT1) n = 25	Cohort 2 (8 Weeks GT1) n = 20	Cohort 3 (6 Weeks GT1) n = 20	Cohort 4 (12 Weeks GT1) n = 8	Cohort 5a (8 Weeks GT3) n = 5	Cohort 5b (12 Weeks GT3) n = 14	Cohort 6,7,8 (8 Weeks GT1 F4) n = 30	Cohort 9 (12 Weeks GT1 F4) n = 15	Cohort 11 (12 Weeks GT2 F4) n = 4
Value	17	19	14	13	7	4	13	17	10	4

Population analysed: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.

Primary outcome: Body Weight at End of Treatment

Time frame: End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks). Mean (Standard Deviation). Unit: Kilograms (kg)

Measure	Cohort 1 (8 Weeks Genotype [GT1]) n = 19	Cohort 1b + Cohort 4 (8 Weeks GT1) n = 25	Cohort 2 (8 Weeks GT1) n = 20	Cohort 3 (6 Weeks GT1) n = 20	Cohort 4 (12 Weeks GT1) n = 8	Cohort 5a (8 Weeks GT3) n = 5	Cohort 5b (12 Weeks GT3) n = 14	Cohort 6,7,8 (8 Weeks GT1 F4) n = 30	Cohort 9 (12 Weeks GT1 F4) n = 15	Cohort 11 (12 Weeks GT2 F4) n = 4
Value	76.02 (15.13)	84.58 (15.09)	80.19 (17.79)	74.07 (12.78)	73.09 (8.62)	81.30 (13.82)	81.83 (13.67)	80.15 (17.92)	86.02 (15.56)	69.90 (11.55)

Population analysed: Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.

Primary outcome: Body Mass Index (BMI) at End of Treatment

Measure	Cohort 1 (8 Weeks Genotype [GT1]) n = 19	Cohort 1b + Cohort 4 (8 Weeks GT1) n = 25	Cohort 2 (8 Weeks GT1) n = 20	Cohort 3 (6 Weeks GT1) n = 20	Cohort 4 (12 Weeks GT1) n = 8	Cohort 5a (8 Weeks GT3) n = 5	Cohort 5b (12 Weeks GT3) n = 14	Cohort 6,7,8 (8 Weeks GT1 F4) n = 30	Cohort 9 (12 Weeks GT1 F4) n = 15	Cohort 11 (12 Weeks GT2 F4) n = 4
Value	25.89 (4.63)	28.43 (4.26)	26.45 (5.53)	25.46 (3.53)	25.60 (3.21)	25.60 (2.82)	26.17 (4.20)	27.69 (5.28)	27.98 (4.37)	23.64 (4.50)

Primary outcome: Percentage of Participants With Worst Post-Baseline Values of Vital Signs

Time frame: Up to 43 weeks. Number. Unit: Percentage of participants

Measure	Cohort 1 (8 Weeks Genotype [GT1]) n = 20	Cohort 1b + Cohort 4 (8 Weeks GT1) n = 25	Cohort 2 (8 Weeks GT1) n = 20	Cohort 3 (6 Weeks GT1) n = 20	Cohort 4 (12 Weeks GT1) n = 8	Cohort 5a (8 Weeks GT3) n = 5	Cohort 5b (12 Weeks GT3) n = 14	Cohort 6,7,8 (8 Weeks GT1 F4) n = 30	Cohort 9 (12 Weeks GT1 F4) n = 15	Cohort 11 (12 Weeks GT2 F4) n = 4
sBP: Abnormally low	0	0	0	0	0	0	0	3.3	0	0
sBP: Grade 1 or mild	20.0	32.0	35.0	25.0	37.5	60.0	57.1	26.7	46.7	25.0
sBP: Grade 2 or moderate	10.0	8.0	0	5.0	37.5	0	7.1	20.0	13.3	50.0
sBP: Grade 3 or severe	0	4.0	5.0	0	0	0	0	3.3	13.3	0
dBP: Abnormally low	0	4.0	0	0	12.5	0	0	0	0	0
dBP: Grade 1 or mild	5.0	20.0	35.0	20.0	0	60.0	21.4	10.0	26.7	0
dBP: Grade 2 or moderate	5.0	12.0	0	0	0	0	14.3	13.3	6.7	25.0
dBP: Grade 3 or severe	0	0

34 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 43 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 (8 Weeks Genotype [GT1])	1 of 20 (5%)	17 of 20 (85%)	0 of 20
Cohort 1b + Cohort 4 (8 Weeks GT1)	2 of 25 (8%)	20 of 25 (80%)	0 of 25
Cohort 2 (8 Weeks GT1)	0 of 20 (0%)	14 of 20 (70%)	0 of 20
Cohort 3 (6 Weeks GT1)	0 of 20 (0%)	14 of 20 (70%)	0 of 20
Cohort 4 (12 Weeks GT1)	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Cohort 5a (8 Weeks GT3)	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Cohort 5b (12 Weeks GT3)	0 of 14 (0%)	13 of 14 (92.9%)	0 of 14
Cohort 6,7,8 (8 Weeks GT1 F4)	1 of 30 (3.3%)	18 of 30 (60%)	0 of 30
Cohort 9 (12 Weeks GT1 F4)	2 of 15 (13.3%)	10 of 15 (66.7%)	0 of 15
Cohort 11 (12 Weeks GT2 F4)	1 of 4 (25%)	4 of 4 (100%)	0 of 4

Limitations and caveats (from the sponsor): Limitations of the study included the open-label design, limited sample size, and the lack of a comparator group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alios Biopharma Inc. Clinical Trial study director

Alios Biopharma Inc.

11 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AL-335, Odalasvir (ODV) and Simeprevir (SMV) in people with Chronic Hepatitis C, run by Alios Biopharma Inc. at 11 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in New Zealand, United Kingdom, Mauritius, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Event (TEAE) (time frame: Up to 43 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02569710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.