Trials / Completed
CompletedNCT03593447
To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in HCV Genotype I Infected Patients
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin | Group1: TG-2349 200 mg + DAG181 100 mg + Ribavirin 1000 mg or 1200 mg |
| DRUG | non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin | Group2: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg |
| DRUG | non-cirrhotic subjects. low TG-2349+ low DAG181 | Group 3: TG-2349 200 mg + DAG181 100 mg |
| DRUG | non-cirrhotic subjects. high TG-2349+ high DAG181 | Group 4: TG-2349 400 mg + DAG181 200 mg |
| DRUG | cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin | Group 5: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg\_ |
| DRUG | cirrhotic subjects. high TG-2349+ high DAG181 | Group6: TG-2349 400 mg + DAG181 200 mg |
Timeline
- Start date
- 2018-03-15
- Primary completion
- 2019-04-23
- Completion
- 2020-02-17
- First posted
- 2018-07-20
- Last updated
- 2021-02-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03593447. Inclusion in this directory is not an endorsement.