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A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB

StatusNot Yet Recruiting
PhasePhase 3
Started2025-08
View on ClinicalTrials.gov ↗

Amendment history

2025-07-30
Study Identification, Study Status, Outcome Measures v1
Secondary endpoints10 entries, revised
To evaluate the safetySafety of ZM-H1505R in combination with NAs versus NAs monotherapy [...]
Study title-53 characters
A Phase III Study to Evaluate the Efficacy and Safety of ZMH1505R in Combination With NAs Compared With NAs MonotherapyZM-H1505R in Patients With CHB
2025-07-23
Original filing
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.
Trial Details
NCT Number NCT07095855
Lead Sponsor Shanghai Zhimeng Biopharma, Inc.
Conditions Chronic Hepatitis B
Enrollment 1,300 participants
Start Date 2025-08
Primary Completion 2028-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-03