Hepatitis CPhase 2NCT01425970
Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects: Part A: Safety and Efficacy of INX-08189 With Peg IFN Alfa-2a and Ribavirin. Part B: INX-08189 in Interferon Free Treatment With Daclatasvir and/or Ribavirin
A Phase 2 study testing INX-08189, Pegylated interferon alfa-2a and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 6 sites in United States.
Trial summary
Part A: The purpose of this study is to evaluate the safety and tolerability of INX-08189 and placebo with Peginterferon alfa-2a and Ribavirin during 12 weeks of treatment Part B: The purpose of this study is to evaluate the safety and tolerability of INX-08189 with Ribavirin or INX-08189 with Daclatasvir or INX-08189… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- INX-08189, Pegylated interferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2012to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Amendment 4: Genotype 1, 10 subjects at site 401.
- Males and females, 18 to 65 years of age inclusive with a body mass index (BMI) of at least 18 kg/m2 but not exceeding 36 kg/m2
- Diagnosed with chronic HCV at least 6 months prior to Visit 1 with medical documentation (e.g., prior PCR result, prior liver biopsy, prior genotyping, etc.), with a positive HCV viral load of at least 50,000 IU/mL at Visit 1 (screening) as measured by quantitative PCR
- Chronic genotype 2 or 3 HCV infection (per polymerase chain reaction [PCR] methodology)
- HCV treatment-naïve where "treatment-naïve" is defined as no prior treatment with IFN alfa 2a or 2b, Pegylated IFN alfa-2a, Ribavirin, or any HCV direct-acting anti-viral drugs
- Liver biopsy consistent with chronic HCV infection but with a classification of non-cirrhotic (and without classification of 'transition to cirrhosis or borderline cirrhosis') as judged by a pathologist (defined as Knodell ≤ 3, Metavir ≤ 2, Ishak ≤ 4, or Batts \&Ludwig ≤ 2 ) within the last two years and before Visit 2 (biopsy can be done after Visit 1 and before Visit 2, within the screening period)
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- Negative urine drug screen for drugs of abuse and methadone (via central lab-provided dipstick at site) at screening (Visit 1) (note: subjects with a valid prescription for a drug which can be abused [e.g., benzodiazepine, opiates] can be enrolled on the judgment of the investigator)
- Females will have a negative serum beta human chorionic gonadotropin (βHCG) pregnancy test at screening and a negative urine dipstick pregnancy test on Study Day 0 (visit 2)
- Agreement by both female subjects of childbearing potential and male subjects (who have not been surgically sterilized) to practice an acceptable method of birth control, which includes at least one barrier during the study and for at least 6 months after the cessation of treatment. Surgical sterilization of either the female or the male partner must have occurred at least 6 months prior to the first dose and females must be post-menopausal for 2 years to be considered of non-child-bearing potential. Acceptable contraceptive methods include one of the following: Oral and implantable hormonal contraceptives by the female partner for at least 3 months prior to the first dose of Study Drug with additional use of a barrier method, IUD in place for at least 6 months prior to first dose with additional use of barrier method. Acceptable barrier methods include either diaphragm with spermicide, and condom with spermicide. (Note: Abstinence is not an acceptable method of birth control, subjects who indicate sexual inactivity must agree to utilize an acceptable method of birth control in the event of sexual activity)
- Willing and able to complete all study visits and procedures, and able to effectively communicate with the investigator and other testing center personnel
- Signed informed consent form (ICF) executed prior to protocol screening assessments
Who cannot join
- Signs or symptoms of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by an indirect bilirubin > 2, Alanine transaminase (ALT) or Aspartate aminotransferase (AST) laboratory values ≥ 10 times the upper limit of normal, or other evidence of decompensated liver disease, or hepatocellular carcinoma
- Chronic liver disease other than HCV not limited to Hepatitis B virus (HBV) [positive test for hepatitis B surface antigen (HBsAg)], hemochromatosis, auto-immune hepatitis, alcoholic liver disease or non-alcoholic fatty liver disease
- History of liver transplantation
- Co-infection with Human immunodeficiency virus (HIV) [positive test for anti-HIV Ab] or use of didanosine
- History of a heart attack, cardiac ischemia, heart disease, clinically symptomatic cardiac abnormalities, or blood clots, based on medical history or apparent on physical exam
- QTcF interval at Visit 1 of greater than or equal to 450 ms by Fridericia's correction, or a personal or family history of Torsades de Pointe
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- History or presence of sarcoidosis or pancreatitis
- History or presence of severe pulmonary function impairment including severe (> GOLD stage III) chronic obstructive pulmonary obstructive disease, and moderate to severe asthma
- Uncontrolled diabetes mellitus as evidenced by HbA1C ≥ 8.5% at screening (Visit 1)
- Use of the following medications concurrently or within the 30 days prior to Screening (Visit 1) associated with QT prolongation: macrolides, antiarrhythmic agents, azoles, fluoroquinolones, and tricyclic anti-depressants (specifically excluded medication will be listed in protocol Section 6.8)
- Use of immunosuppressive or immune-modulating agents (including azathioprine, corticosteroids and immunosuppressive agents) or presence of an immunologically-mediated autoimmune disease (other than asthma) or history of solid organ or bone marrow transplantation (note: inhaled steroids for mild/moderate asthma and topical steroid for minor skin conditions allowed and washout period for per Oral (PO)/Intramuscular (IM)/ Intravenous (IV) corticosteroid use is 8 weeks; washout periods for other immunosuppressives determined by Medical Monitor)
- Use of strong CYP3A4-inhibiting protease inhibitors (specifically Atazanavir, Indinavir, Nelfinavir, Saquinavir, and Ritonavir), strong CYP3A4 inhibitors (specifically Clarithromycin, Itraconazole, Ketoconazole, Nefazodone, Telithromycin), or strong CYP3A4 inducers (specifically Rifampin, Efavirenz, Etravirine, Phenobarbital, Phenytoin, and Carbamazepine)
- Absolute neutrophil count of < 1800 cells/mm3, or platelet count < 130,000 cells/mm3, or hemoglobin < 12 g/dl for women and < 13 g/dl for men, or a history of anemia, sickle cell anemia, or thalassemia; (note: if baseline value within 5% of minimum qualifying value, one re-test allowed for the purpose of qualifying for study)
- A history or presence of abnormal thyroid function that is not adequately controlled [defined as Thyroid-stimulating hormone (TSH) levels less than 0.8 x lower limit of normal (LLN) or greater than 1.2 x the upper limit of normal (ULN)]
- Creatinine clearance < 50 mL/minute, serum creatinine concentration ≥ 1.5 times the ULN, or albumin ≤ 3 g/dl
- Presence or history of bipolar disorder, schizophrenia, psychosis, or unstable psychiatric condition, or hospitalization for psychiatric condition, or suicide attempt. (Note: Subjects with psychiatric conditions need to be adequately treated and on stable doses of appropriate medications for at least 3 months prior to Visit 1. History of suicidal ideation within prior 3 months is exclusionary)
- Any malignancy within the last 5 years other than treated cervical carcinoma in situ or treated basal cell carcinoma with no more than 20% risk of recurrence within 2 years
- Alcohol abuse by the assessment of the investigator within the past 2 years or an alcohol use pattern that will interfere with the study conduct
- Drug abuse by the assessment of the investigator within the last six months
- Pregnancy, current lactation in female subjects, or male subjects with partners who are pregnant, or females intending to become pregnant
- Major surgery within 30 days prior to Visit 1
- Participation in another clinical trial of an investigational drug or device within 6 months prior to Visit 1 unless that prior participation involved exposure only to placebo by clear and available documentation
- Donation of blood or plasma within 30 days prior to Visit 1 (not including routine laboratory assessments)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Acri Phase One
Anaheim, California, 92801
Kansas City Cancer Centers, Llc.
Kansas City, Missouri, 64111
Scripps Health Dba Scripps Clinical Research Services
La Jolla, California, 92037
Alamo Medical Research
San Antonio, Texas, 78215
Quest Clinical Research
San Francisco, California, 94115
Options Health Research, Llc
Tulsa, Oklahoma, 74104
About this study
Official title: A Phase II, Randomized, Multi-center, Two Part Study of the Safety and Efficacy of Double-blind, Placebo-controlled INX-08189 in Adjunctive Treatment With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Study Part A, and Open-label INX-08189 in Adjunctive (Interferon Free) Treatment With Daclatasvir and/or Ribavirin (Copegus®) in Study Part B, in Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects
Part A: The purpose of this study is to evaluate the safety and tolerability of INX-08189 and placebo with Peginterferon alfa-2a and Ribavirin during 12 weeks of treatment
Part B: The purpose of this study is to evaluate the safety and tolerability of INX-08189 with Ribavirin or INX-08189 with Daclatasvir or INX-08189 with Daclatasvir and Ribavirin
Read the detailed description
Data Monitoring Committee is appointed for Part A only
Masking: Part A of this study is Double blind and the Part B is Open Label
- Conditions
- Hepatitis C
- Being tested
- INX-08189, Placebo matching with INX-08189, Pegylated interferon alfa-2a, Ribavirin, Daclatasvir
- Keywords
- Inhibitex, Chronic Hepatitis, Hepatitis C Virus
- Medical subject headings
- Hepatitis C, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INX-08189Drug
Tablet, Oral, 25 mg, Once daily (QD), 12 weeks
INX-08189Drug
Tablet, Oral, 50 mg, Once daily (QD), 12 weeks
INX-08189Drug
Tablet, Oral, 100 mg, Once daily (QD), 12 weeks
Placebo matching with INX-08189Drug
Tablet, Oral, 0 mg, Once daily (QD), 12 weeks
Pegylated interferon alfa-2aBiological
Syringe, Subcutaneous injection, 180 μg, Once per week, 12 weeks
RibavirinDrug
Tablet, Oral, 500 or 600 mg weight dependent, Twice daily (BID), 12 weeks
INX-08189Drug
Tablet, Oral, 200 mg, QD, 12 weeks
DaclatasvirDrug
Also called BMS-790052
Tablet, Oral, 60 mg, QD, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 25 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin | Experimental | PART A Arm 1 Receives: Drug: INX-08189; Biological: Pegylated interferon alfa-2a; Drug: Ribavirin |
| 50 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin | Experimental | PART A Arm 2 Receives: Drug: INX-08189; Biological: Pegylated interferon alfa-2a; Drug: Ribavirin |
| 100 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin | Experimental | PART A Arm 3 Receives: Drug: INX-08189; Biological: Pegylated interferon alfa-2a; Drug: Ribavirin |
| Placebo + Pegylated interferon alfa-2a + Ribavirin | Placebo comparator | PART A Arm 4 Receives: Drug: Placebo matching with INX-08189; Biological: Pegylated interferon alfa-2a; Drug: Ribavirin |
| 100 mg INX-08189 + Ribavirin | Experimental | PART B Arm 1 Receives: Drug: INX-08189; Drug: Ribavirin |
| 200 mg INX-08189 + Ribavirin | Experimental | PART B Arm 2 Receives: Drug: Ribavirin; Drug: INX-08189 |
| Daclatasvir + INX-08189 100 mg | Experimental | PART B Arm 3 Receives: Drug: INX-08189; Drug: Daclatasvir |
| Daclatasvir + INX-08189 200 mg | Experimental | PART B Arm 4 Receives: Drug: INX-08189; Drug: Daclatasvir |
| Daclatasvir + INX-08189 50 mg + Ribavirin | Experimental | PART B Arm 5 Receives: Drug: INX-08189; Drug: Ribavirin; Drug: Daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Change in Hepatitis C Viral Load Measurements at protocol specific timepoints
Measured: Weeks -6, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 36, 48
Part B: proportion of subjects with SVR defined as HCV RNA ≤ LOQ (Limit of Quantitation)
- SVR = Sustained virologic response
- HCV RNA = Hepatitis C virus ribonucleic acid
Measured: At treatment weeks 12
Part B: proportion of subjects with SVR defined as HCV RNA ≤ LOQ
Measured: Post treatment week 12
Safety assessments is measured by Physical Exams, vital signs, laboratory assessments, ECGs, pregnancy test, viral resistance testing, adverse event assessment
Measured: up to 1 year
Secondary outcomes (4)
Proportion of subjects with RVR (Rapid Virologic Response), undetectable HCV RNA
Measured: At treatment weeks 4
Proportion of subjects with Complete EVR (Early Virologic Response), undetectable HCV RNA
Measured: At treatment weeks 12
Proportion of subjects with Extended RVR
Measured: At treatment weeks 4 and 12
Proportion of subjects with SVR24
SVR24 = sustained virologic response at 24 weeks after the cessation of treatment
Measured: Post treatment week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Termination of study was due to safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425970
- Sponsor's protocol ID
- AI472-003
- Other IDs
- INH-189-003
- Status last verified
- Oct 2015
- First submitted
- 25 Aug 2011
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Multi-center, Two Part Study of the Safety and Efficacy of Double-blind, Placebo-controlled INX-08189 in Adjunctive Treatment With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Study Part A, and Open-label INX-08189 in Adjunctive (Interferon Free) Treatment With Daclatasvir and/or Ribavirin (Copegus®) in Study Part B, in Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects
- ClinicalTrials.gov ID
- NCT01425970
- Acronym / sponsor ID
- AI472-003
- Conditions
- Hepatitis C
- Keywords
- Inhibitex, Chronic Hepatitis, Hepatitis C Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination of study was due to safety reasons
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part A: The purpose of this study is to evaluate the safety and tolerability of INX-08189 and placebo with Peginterferon alfa-2a and Ribavirin during 12 weeks of treatment
Part B: The purpose of this study is to evaluate the safety and tolerability of INX-08189 with Ribavirin or INX-08189 with Daclatasvir or INX-08189 with Daclatasvir and Ribavirin
Detailed description
Data Monitoring Committee is appointed for Part A only
Masking: Part A of this study is Double blind and the Part B is Open Label
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 25 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin | Experimental | Drug: INX-08189, Biological: Pegylated interferon alfa-2a, Drug: RibavirinPART A Arm 1 |
| 50 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin | Experimental | Drug: INX-08189, Biological: Pegylated interferon alfa-2a, Drug: RibavirinPART A Arm 2 |
| 100 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin | Experimental | Drug: INX-08189, Biological: Pegylated interferon alfa-2a, Drug: RibavirinPART A Arm 3 |
| Placebo + Pegylated interferon alfa-2a + Ribavirin | Placebo comparator | Drug: Placebo matching with INX-08189, Biological: Pegylated interferon alfa-2a, Drug: RibavirinPART A Arm 4 |
| 100 mg INX-08189 + Ribavirin | Experimental | Drug: INX-08189, Drug: RibavirinPART B Arm 1 |
| 200 mg INX-08189 + Ribavirin | Experimental | Drug: Ribavirin, Drug: INX-08189PART B Arm 2 |
| Daclatasvir + INX-08189 100 mg | Experimental | Drug: INX-08189, Drug: DaclatasvirPART B Arm 3 |
| Daclatasvir + INX-08189 200 mg | Experimental | Drug: INX-08189, Drug: DaclatasvirPART B Arm 4 |
| Daclatasvir + INX-08189 50 mg + Ribavirin | Experimental | Drug: INX-08189, Drug: Ribavirin, Drug: DaclatasvirPART B Arm 5 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Amendment 4: Genotype 1, 10 subjects at site 401.
- Males and females, 18 to 65 years of age inclusive with a body mass index (BMI) of at least 18 kg/m2 but not exceeding 36 kg/m2
- Diagnosed with chronic HCV at least 6 months prior to Visit 1 with medical documentation (e.g., prior PCR result, prior liver biopsy, prior genotyping, etc.), with a positive HCV viral load of at least 50,000 IU/mL at Visit 1 (screening) as measured by quantitative PCR
- Chronic genotype 2 or 3 HCV infection (per polymerase chain reaction [PCR] methodology)
- HCV treatment-naïve where "treatment-naïve" is defined as no prior treatment with IFN alfa 2a or 2b, Pegylated IFN alfa-2a, Ribavirin, or any HCV direct-acting anti-viral drugs
Key exclusion criteria (23 listed)
- Signs or symptoms of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by an indirect bilirubin > 2, Alanine transaminase (ALT) or Aspartate aminotransferase (AST) laboratory values ≥ 10 times the upper limit of normal, or other evidence of decompensated liver disease, or hepatocellular carcinoma
- Chronic liver disease other than HCV not limited to Hepatitis B virus (HBV) [positive test for hepatitis B surface antigen (HBsAg)], hemochromatosis, auto-immune hepatitis, alcoholic liver disease or non-alcoholic fatty liver disease
- History of liver transplantation
- Co-infection with Human immunodeficiency virus (HIV) [positive test for anti-HIV Ab] or use of didanosine
- History of a heart attack, cardiac ischemia, heart disease, clinically symptomatic cardiac abnormalities, or blood clots, based on medical history or apparent on physical exam
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 |
|---|---|---|
| INX-08189Tablet, Oral, 25 mg, Once daily (QD), 12 weeks | Drug | 25 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin |
| INX-08189Tablet, Oral, 50 mg, Once daily (QD), 12 weeks | Drug | 50 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin, Daclatasvir + INX-08189 50 mg + Ribavirin |
| INX-08189Tablet, Oral, 100 mg, Once daily (QD), 12 weeks | Drug | 100 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin, 100 mg INX-08189 + Ribavirin, Daclatasvir + INX-08189 100 mg |
| Placebo matching with INX-08189Tablet, Oral, 0 mg, Once daily (QD), 12 weeks | Drug | Placebo + Pegylated interferon alfa-2a + Ribavirin |
| Pegylated interferon alfa-2aSyringe, Subcutaneous injection, 180 μg, Once per week, 12 weeks | Biological | 100 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin, 25 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin, 50 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin, Placebo + Pegylated interferon alfa-2a + Ribavirin |
| RibavirinTablet, Oral, 500 or 600 mg weight dependent, Twice daily (BID), 12 weeks | Drug | 100 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin, 100 mg INX-08189 + Ribavirin, 200 mg INX-08189 + Ribavirin, 25 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin, 50 mg INX-08189 + Pegylated interferon alfa-2a + Ribavirin, Daclatasvir + INX-08189 50 mg + Ribavirin, Placebo + Pegylated interferon alfa-2a + Ribavirin |
| INX-08189Tablet, Oral, 200 mg, QD, 12 weeks | Drug | 200 mg INX-08189 + Ribavirin, Daclatasvir + INX-08189 200 mg |
| DaclatasvirAlso: BMS-790052Tablet, Oral, 60 mg, QD, 12 weeks | Drug | Daclatasvir + INX-08189 100 mg, Daclatasvir + INX-08189 200 mg, Daclatasvir + INX-08189 50 mg + Ribavirin |
Primary outcome
Part A: Change in Hepatitis C Viral Load Measurements at protocol specific timepoints
Time frame: Weeks -6, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 36, 48
Part B: proportion of subjects with SVR defined as HCV RNA ≤ LOQ (Limit of Quantitation)
Time frame: At treatment weeks 12
* SVR = Sustained virologic response * HCV RNA = Hepatitis C virus ribonucleic acid
Part B: proportion of subjects with SVR defined as HCV RNA ≤ LOQ
Time frame: Post treatment week 12
Safety assessments is measured by Physical Exams, vital signs, laboratory assessments, ECGs, pregnancy test, viral resistance testing, adverse event assessment
Time frame: up to 1 year
4 secondary outcomes
Proportion of subjects with RVR (Rapid Virologic Response), undetectable HCV RNA
Time frame: At treatment weeks 4
Proportion of subjects with Complete EVR (Early Virologic Response), undetectable HCV RNA
Time frame: At treatment weeks 12
Proportion of subjects with Extended RVR
Time frame: At treatment weeks 4 and 12
Proportion of subjects with SVR24
Time frame: Post treatment week 24
Results and safety
The study was stopped early (reason given: Termination of study was due to safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INX-08189, Pegylated interferon alfa-2a and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 6 sites in United States.
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 11 inclusion and 23 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: stopped early, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Termination of study was due to safety reasons). Results are not available in the source record.
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?
Part A: Change in Hepatitis C Viral Load Measurements at protocol specific timepoints (time frame: Weeks -6, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 36, 48). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2015.