drugset / Trial / NCT07179653
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Chronic Hepatitis B Patients
Phase 2
Active not recruiting
48 enrolled
Grand Theravac Life Sciences (Nanjing) Co., Ltd.
Meng Chao Hepatobiliary Hospital of Fujian Medical University · collabNanfang Hospital, Southern Medical University · collabRuijin Hospital · collabSichuan Provincial People's Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this study was to evaluate the efficacy and safety of TVAX- 008 injection in a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II clinical trial in subjects with HBSAg levels of 0.05 to 100 IU/mL, including CHB patients previously treated with siRNA/ASO drugs and treatment-naive HBV infection.
Timeline
- Start
- 2025-01-22
- Primary completion
- 2025-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TVAX-008 | Unknown | — | — |