Trials / Completed
CompletedNCT05395416
Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C
A Phase Ⅱ/Ⅲ Study to Evaluate Efficacy and Safety of Antaitavir Hasophate Capsules in Combination With Yiqibuvir Tablets in Adult Subject With Chronic HCV Infection
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 514 (actual)
- Sponsor
- Sunshine Lake Pharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The safety, tolerability and antiviral activity of Antaitavir Hasophate in Combination With Yiqibuvir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) infection
Detailed description
Phase II: Exploring the efficacy and safety of different doses of Antaitavir Hasophate combined with fixed-dose Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials. Phase III: Confirmation of the efficacy and safety of Antaitavir Hasophate combined with Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HEC74647PA+HEC110114 | administered orally once daily for 12 weeks |
| DRUG | Placebo | administered orally once daily for 12 weeks |
Timeline
- Start date
- 2021-06-21
- Primary completion
- 2023-04-11
- Completion
- 2023-04-11
- First posted
- 2022-05-27
- Last updated
- 2025-05-14
Locations
36 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05395416. Inclusion in this directory is not an endorsement.