Chronic Hepatics C Virus (HCV) Genotype 1Phase 2NCT03593447

To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in HCV Genotype I Infected Patients

A Phase 2 study testing non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin, non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin and non-cirrhotic subjects. low TG-2349+ low DAG181 in people with Chronic Hepatics C Virus (HCV) Genotype 1 and Non-Cirrhotic, run by Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd. at 1 site in China.

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

A phase II study to evaluate the efficacy and safety in TG-2349 combination with DAG181 (± Ribavirin) in treatment naïve subjects with chronic hepatic C virus genotype I infection. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Chronic Hepatics C Virus (HCV) Genotype 1, Non-Cirrhotic, Cirrhosis
What is being tested?: non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin, non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin and non-cirrhotic subjects. low TG-2349+ low DAG181
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 1 siteChina
Study dates: 15 Mar 2018to 17 Feb 2020
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Before starting the study, an informed consent form (ICF) approved by the Institutional Review Board (IRB) is obtained from the subject or his/her legal representative；
Male or female, and 18 to 45 years of age inclusive when signing ICF；
Body mass index (BMI) in the range of 18.0 to 35.0kg/m2 and body weight ≥ 40 kg at Screening；
Presence of chronic hepatitis C (CHC) as documented below: (1)A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit or, (2) A liver biopsy or FibroTest performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection, such as the presence of fibrosis and/or inflammation；
Positive for anti-HCV antibody at Screening；
Presence of an HCV RNA level ≥ 1 x 104 IU/mL at Screening as determined by the Central Laboratory；

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Presence of genotype 1a, 1b, or 1a/1b combination HCV-infection at Screening as determined by the Central Laboratory；
HCV treatment naïve defined as no prior therapy with any interferon (IFN), ribavirin (RBV), or other approved or investigational HCV-specific agent；
Without (group 1 to 4) or with (group5 to 6) cirrhosis: (1) Without cirrhosis as defined as any one of the following: (a) Liver biopsy without showing cirrhosis (e.g., Metavir score < F4 or Ishak score < 5) within one year prior to Screening or at Screening. (b) FibroScan showing cirrhosis or results ≤ 12.5 kPa within six months prior to Screening or at Screening. (2) With cirrhosis as defined as any one of the following: (a) Liver biopsy showing cirrhosis (e.g., Metavir score = F4 or Ishak score ≥ 5) within one year prior to Screening or at Screening. (b) FibroScan showing cirrhosis or results > 12.5 kPa within six months prior to Screening or at Screening；NOTICE: If there is liver biopsy, liver biopsy results will supersede non-invasive testing results and be considered definitive.
ECG without clinically significant abnormalities at Screening；
Subjects must have the following laboratory parameters at Screening: (1) ALT ≤ 10 × the upper limit of normal (ULN). (2) AST ≤ 10 × ULN. (3) Without cirrhosis: Total bilirubin ≤ 1.5 × ULN except history of Gilbert's syndrome. If Gilbert's syndrome is the proposed etiology, the total bilirubin must ≤ 2 × ULN. With cirrhosis: Total bilirubin ≤ 2 × ULN. (4) Platelet count ≥ 90,000 cells/mm3. (5) Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3. (6) HbA1c ≤ 8.5%. (7) Creatinine clearance (CLcr) ≥ 50 mL /min, as calculated by the Cockcroft-Gault equation. (8) Hemoglobin ≥ 110 g/L for female subjects; ≥ 120 g/L for male subjects. (9) Without cirrhosis Albumin ≥ 3.5 g/dL；With cirrhosis Albumin ≥30g/L. (10) Without cirrhosis INR ≤ 1.5 x ULN；With cirrhosis INR ≤ 1.7 x ULN. (11) Alpha fetoprotein (AFP)<100 ng/mL；20ng/mL≤AFP≤100ng/mL need to take Liver Ultrasonic testing to exclude subjects with suspicious liver cancer cells. (12) Anti-nuclear antibodies (ANA) ≤ 1:320；
A female subject is eligible to enter the study if it is confirmed that she is: (1) Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal - women > 50 years of age with cessation (for ≥12 months) of previously occurring menses), or (2) Of childbearing potential (Women ≤ 50 years of age with amenorrhea will be considered to be of childbearing potential). These women must have a negative serum pregnancy test at Screening and agree to consistently and correctly use an approved contraceptive method (i.e. abstinence, vaginal ring, cervical cap, contraceptive diaphragm, or intrauterine devices) from screening until at least 6 months after the last dose of study drug(s)；
Male subjects must agree to consistently and correctly use an approved contraceptive method (i.e. abstinence, condom, or spouses using contraceptive drugs, vaginal ring, cervical cap, contraceptive diaphragm, or intrauterine devices) from screening until at least 6 months after the last dose of study drug(s)；
Male subjects must agree to refrain from sperm donation from screening until at least 6 months after the last dose of study drug(s)；
Subject must be of generally good health, with the exception of chronic HCV infection, as determined by Investigator；
Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments, including all required post-treatment visits.

Who cannot join

Positive serological test for IgM anti-HAV or anti-HEV antibody at Screening；
Positive serological test for HBsAg at Screening；
Positive test for HIV-1 or HIV-2 at Screening；
Donation or loss of more than 400 mL blood within 3 months prior to Baseline/Day 1；
Clinically-relevant drug abuse within 12 months of signing the ICF. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by Investigator；
Alcohol misuse as defined by an AUDIT score of ≥ 8；

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Contraindications to RBV or IFN therapy, including hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia)；
Pregnant or nursing female or male with pregnant female partner；
Use of any prohibited medications within 30 days of the Baseline/Day 1 visit；
Known hypersensitivity to TG-2349, DAG181, RBV, sulfa drugs, or formulation excipients；
Current or prior history of any of the following: (1) Chronic hepatic disorder not induced by HCV (including but not limited to Hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cholangitis, autoimmune hepatitis, alcoholic liver disease, drug-induced liver disease. (2) Decompensated liver cirrhosis (Child-Pugh class B and C). (3) Any dysphagia, malabsorption syndrome, or other gastrointestinal disturbances affecting drug absorption. (4) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. (5) Central nervous system (CNS) trauma, seizure disorder, stroke or transient ischemic attack. (6) Solid organ transplantation. (7) Significant cardiac disease (including but not limited to the myocardial infarction based on ECG and/or clinical history). (8) Significant pulmonary disease or porphyria (e.g. lung infiltration or impaired lung function). (9) Pancreatitis. (10) Autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, psoriasis). (11) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. (12) Malignancy within 5 years prior to Screening, with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible. (13) Serious acute drug allergy (such as anaphylaxis or hepatotoxicity) or serious skin hypersensitive reaction (such as vesicular rash, Stevens Johnson Syndrome)；
As determined by Investigator, a subject that would affect the therapy, evaluation or compliance with the protocol is not suitable to take part in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Peoples Hospital
Beijing, Beijing Municipality, 10004

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-label, Dose-ranging, Phase II Study to Evaluate the Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in Treatment naïve Subjects With Chronic Hepatic C Virus Genotype I Infection

A phase II study to evaluate the efficacy and safety in TG-2349 combination with DAG181 (± Ribavirin) in treatment naïve subjects with chronic hepatic C virus genotype I infection.

Read the detailed description

The purpose of this phase II study is to evaluate the efficacy and safety in TG-2349 combination with DAG181 (± Ribavirin) in treatment naïve subjects with chronic hepatic C virus genotype I infection. Approximately 132 subjects will be enrolled in this study and divided into six groups:

Group 1 to 4: Chronic hepatics C virus (HCV) genotype 1 infected, treatment naïve, non-cirrhotic subjects.

Group 5 to 6: Chronic hepatics C virus (HCV) genotype 1 infected, treatment naïve, cirrhotic subjects.

Conditions: Chronic Hepatics C Virus (HCV) Genotype 1, Non-Cirrhotic, Cirrhosis, Treatment naïve
Being tested: non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin, non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin, non-cirrhotic subjects. low TG-2349+ low DAG181, non-cirrhotic subjects. high TG-2349+ high DAG181, cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin
Keywords: Chronic hepatics C virus (HCV) genotype 1, treatment naïve, non-cirrhotic, cirrhotic, efficacy, safety, TG-2349, DAG181, Ribavirin
Medical subject headings: Hepatitis C, Fibrosis

What participants receive

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

non-cirrhotic subjects. low TG-2349+ low DAG181+RibavirinDrug
Group1: TG-2349 200 mg + DAG181 100 mg + Ribavirin 1000 mg or 1200 mg
non-cirrhotic subjects. high TG-2349+ high DAG181+RibavirinDrug
Group2: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg
non-cirrhotic subjects. low TG-2349+ low DAG181Drug
Group 3: TG-2349 200 mg + DAG181 100 mg
non-cirrhotic subjects. high TG-2349+ high DAG181Drug
Group 4: TG-2349 400 mg + DAG181 200 mg
cirrhotic subjects. high TG-2349+ high DAG181+RibavirinDrug
Group 5: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg_
cirrhotic subjects. high TG-2349+ high DAG181Drug
Group6: TG-2349 400 mg + DAG181 200 mg

Study groups in NCT03593447
Study group	Role	What they receive
non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin	Experimental	HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. low dose TG-2349+ low dose DAG181+Ribavirin Receives: Drug: non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin
non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin	Experimental	HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. high dose TG-2349+ high dose DAG181+Ribavirin Receives: Drug: non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin
non-cirrhotic subjects. low TG-2349+ low DAG181	Experimental	HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. low dose TG-2349+ low dose DAG181 Receives: Drug: non-cirrhotic subjects. low TG-2349+ low DAG181
non-cirrhotic subjects. high TG-2349+ high DAG181	Experimental	HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. high dose TG-2349+ high dose DAG181 Receives: Drug: non-cirrhotic subjects. high TG-2349+ high DAG181
cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin	Experimental	HCV genotype 1 infected, treatment naïve, cirrhotic subjects. high dose TG-2349+ high dose DAG181+Ribavirin Receives: Drug: cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin
cirrhotic subjects. high TG-2349+ high DAG181	Experimental	HCV genotype 1 infected, treatment naïve, cirrhotic subjects. high dose TG-2349+ high dose DAG181 Receives: Drug: cirrhotic subjects. high TG-2349+ high DAG181

What is being measured

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

The proportion of antiviral efficacy (HCV RNA < lower limit of quantification, target detected or target not detected) at 12 weeks after the end of treatment
To evaluate the antiviral efficacy of two different doses of TG-2349 combination with two different doses of DAG181(± Ribavirin) as measure by the proportion of subjects achieving sustained viral response (defined as HCV RNA < lower limit of quantification, target detected or target not detected) at 12 weeks after the end of treatment (SVR 12) in treatment naïve subjects with chronic hepatic C virus genotype I infection.
Measured: 12 weeks after the end of treatment

Secondary outcomes (10)

The proportion of subjects achieving HCV RNA < LLOQ, TD or TND after the end of treatment (SVR4, SVR8, and SVR24).
To evaluate the proportion of subjects achieving sustained viral response at 4, 8, and 24 weeks after the end of treatment (SVR4, SVR8, and SVR24).
Measured: 24 weeks after the end of treatment
The proportion of subjects achieving HCV RNA < LLOQ, TD or TND during treatment
To evaluate the proportion of subjects achieving HCV RNA < lower limit of quantification, target detected or target not detected (< LLOQ, TD or TND) during treatment.
Measured: up to 16 weeks
The proportion of subjects achieving HCV RNA < LLOQ, TND during treatment and after the end of treatment.
To evaluate the proportion of subjects achieving HCV RNA < LLOQ, TND during treatment and after the end of treatment.
Measured: up to 40 weeks
the average time of first HCV RNA < LLOQ, TND showing during treatment and after the end of treatment.
To evaluate the average time of first HCV RNA < LLOQ, TND showing during treatment and after the end of treatment.
Measured: up to 40 weeks
the change from baseline of circulating blood HCV RNA
To evaluate the change from baseline of circulating blood HCV RNA during treatment and after the end of treatment.
Measured: up to 40 weeks
the proportion of subjects with virologic failure
To evaluate the proportion of subjects with virologic failure (including breakthrough, rebound, or non-response) during treatment.
Measured: up to 16 weeks
the proportion of subjects with virologic relapse
To evaluate the proportion of subjects with virologic relapse after the end of treatment.
Measured: 24 weeks after the end of treatment
For subjects receiving study drugs who do not achieve SVR, the proportion and changes of TG-2349 or DAG181 resistant virus
For subjects receiving study drugs who do not achieve SVR, the proportion and changes of TG-2349 or DAG181 resistant virus will be monitored.
Measured: 24 weeks after the end of treatment
Cmax
To evaluate the maximum drug concentration in the blood
Measured: up to 2 days
Area Under the Curve [AUC]
To evaluate the drug quantity in the blood
Measured: up to 2 days

Timeline

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

15 Mar 201817 Feb 2020

First posted20 Jul 2018
Study start15 Mar 2018
Primary completion23 Apr 2019
Study completion17 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatics C Virus (HCV) Genotype 1Studies 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: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03593447
Sponsor's protocol ID: TGDAG-C-2
Status last verified: Nov 2019
First submitted: 24 May 2018
Last updated: 18 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-label, Dose-ranging, Phase II Study to Evaluate the Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in Treatment naïve Subjects With Chronic Hepatic C Virus Genotype I Infection
ClinicalTrials.gov ID: NCT03593447
Acronym / sponsor ID: TGDAG-C-2
Conditions: Chronic Hepatics C Virus (HCV) Genotype 1, Non-Cirrhotic, Cirrhosis, Treatment naïve
Keywords: Chronic hepatics C virus (HCV) genotype 1, treatment naïve, non-cirrhotic, cirrhotic, efficacy, safety, TG-2349, DAG181
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Peking University People's Hospital
Study start: 15 Mar 2018 (actual)
Primary completion: 23 Apr 2019 (actual)
Study completion: 17 Feb 2020 (actual)
First posted: 20 Jul 2018 (actual)
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.

A phase II study to evaluate the efficacy and safety in TG-2349 combination with DAG181 (± Ribavirin) in treatment naïve subjects with chronic hepatic C virus genotype I infection.

Detailed description

Group 1 to 4: Chronic hepatics C virus (HCV) genotype 1 infected, treatment naïve, non-cirrhotic subjects.

Group 5 to 6: Chronic hepatics C virus (HCV) genotype 1 infected, treatment naïve, cirrhotic subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin	Experimental	Drug: non-cirrhotic subjects. low TG-2349+ low DAG181+RibavirinHCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. low dose TG-2349+ low dose DAG181+Ribavirin
non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin	Experimental	Drug: non-cirrhotic subjects. high TG-2349+ high DAG181+RibavirinHCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. high dose TG-2349+ high dose DAG181+Ribavirin
non-cirrhotic subjects. low TG-2349+ low DAG181	Experimental	Drug: non-cirrhotic subjects. low TG-2349+ low DAG181HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. low dose TG-2349+ low dose DAG181
non-cirrhotic subjects. high TG-2349+ high DAG181	Experimental	Drug: non-cirrhotic subjects. high TG-2349+ high DAG181HCV genotype 1 infected, treatment naïve, non-cirrhotic subjects. high dose TG-2349+ high dose DAG181
cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin	Experimental	Drug: cirrhotic subjects. high TG-2349+ high DAG181+RibavirinHCV genotype 1 infected, treatment naïve, cirrhotic subjects. high dose TG-2349+ high dose DAG181+Ribavirin
cirrhotic subjects. high TG-2349+ high DAG181	Experimental	Drug: cirrhotic subjects. high TG-2349+ high DAG181HCV genotype 1 infected, treatment naïve, cirrhotic subjects. high dose TG-2349+ high dose DAG181

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (16 listed)

Before starting the study, an informed consent form (ICF) approved by the Institutional Review Board (IRB) is obtained from the subject or his/her legal representative；
Male or female, and 18 to 45 years of age inclusive when signing ICF；
Body mass index (BMI) in the range of 18.0 to 35.0kg/m2 and body weight ≥ 40 kg at Screening；
Presence of chronic hepatitis C (CHC) as documented below: (1)A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit or, (2) A liver biopsy or FibroTest performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection, such as the presence of fibrosis and/or inflammation；
Positive for anti-HCV antibody at Screening；

Key exclusion criteria (12 listed)

Positive serological test for IgM anti-HAV or anti-HEV antibody at Screening；
Positive serological test for HBsAg at Screening；
Positive test for HIV-1 or HIV-2 at Screening；
Donation or loss of more than 400 mL blood within 3 months prior to Baseline/Day 1；
Clinically-relevant drug abuse within 12 months of signing the ICF. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by Investigator；

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
non-cirrhotic subjects. low TG-2349+ low DAG181+RibavirinGroup1: TG-2349 200 mg + DAG181 100 mg + Ribavirin 1000 mg or 1200 mg	Drug	non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin
non-cirrhotic subjects. high TG-2349+ high DAG181+RibavirinGroup2: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg	Drug	non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin
non-cirrhotic subjects. low TG-2349+ low DAG181Group 3: TG-2349 200 mg + DAG181 100 mg	Drug	non-cirrhotic subjects. low TG-2349+ low DAG181
non-cirrhotic subjects. high TG-2349+ high DAG181Group 4: TG-2349 400 mg + DAG181 200 mg	Drug	non-cirrhotic subjects. high TG-2349+ high DAG181
cirrhotic subjects. high TG-2349+ high DAG181+RibavirinGroup 5: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg_	Drug	cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin
cirrhotic subjects. high TG-2349+ high DAG181Group6: TG-2349 400 mg + DAG181 200 mg	Drug	cirrhotic subjects. high TG-2349+ high DAG181

Primary outcome

The proportion of antiviral efficacy (HCV RNA < lower limit of quantification, target detected or target not detected) at 12 weeks after the end of treatment
Time frame: 12 weeks after the end of treatment
To evaluate the antiviral efficacy of two different doses of TG-2349 combination with two different doses of DAG181(± Ribavirin) as measure by the proportion of subjects achieving sustained viral response (defined as HCV RNA < lower limit of quantification, target detected or target not detected) at 12 weeks after the end of treatment (SVR 12) in treatment naïve subjects with chronic hepatic C virus genotype I infection.

10 secondary outcomes

The proportion of subjects achieving HCV RNA < LLOQ, TD or TND after the end of treatment (SVR4, SVR8, and SVR24).
Time frame: 24 weeks after the end of treatment
The proportion of subjects achieving HCV RNA < LLOQ, TD or TND during treatment
Time frame: up to 16 weeks
The proportion of subjects achieving HCV RNA < LLOQ, TND during treatment and after the end of treatment.
Time frame: up to 40 weeks
the average time of first HCV RNA < LLOQ, TND showing during treatment and after the end of treatment.
Time frame: up to 40 weeks
the change from baseline of circulating blood HCV RNA
Time frame: up to 40 weeks
the proportion of subjects with virologic failure
Time frame: up to 16 weeks
the proportion of subjects with virologic relapse
Time frame: 24 weeks after the end of treatment
For subjects receiving study drugs who do not achieve SVR, the proportion and changes of TG-2349 or DAG181 resistant virus
Time frame: 24 weeks after the end of treatment
Cmax
Time frame: up to 2 days
Area Under the Curve [AUC]
Time frame: up to 2 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.

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.

Lai Wei, MD principal investigator

Peking University Peoples Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 12 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The proportion of antiviral efficacy (HCV RNA < lower limit of quantification, target detected or target not detected) at 12 weeks after the end of treatment (time frame: 12 weeks after the end of treatment). 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 NCT03593447.

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 18 Feb 2021.