drugset / Trial / NCT07095855
A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU/mL and are HBeAg positive who have received NAs monotherapy for at least 12months.Part B is an open-label extension and follow-up period designed to evaluate the long-term safety and efficacy of ZM-H1505R in combination with NAs.
Timeline
- Start
- 2025-08
- Primary completion
- 2028-01
- Completion
- 2030-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Canocapavir | Small molecule | 100 mg | — |
| Background | Entecavir | Small molecule | — | — |
| Background | TMF | Unknown | — | — |
| Background | Tenofovir | Small molecule | — | — |
| Background | tenofovir alafenamide | Small molecule | — | — |