drugset / Trial / NCT06990776
A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. The purpose is to evaluate the efficacy and safety of TQA3605 tablets combined with entecavir in treatment-naive chronic HBV-infected subjects. A total of 215 subjects are required.
Timeline
- Start
- 2025-07-09
- Primary completion
- 2025-07-17
- Completion
- 2025-07-17
Outcome
Outcome not reported
Stopped: “Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TQA3605 | Unknown | 100 mg | Oral |
| Subject | TQA3605 | Unknown | 200 mg | Oral |
| Background | Entecavir | Small molecule | — | — |