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NOT YET RECRUITING
NCT07095855
PHASE3

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

Sponsor: Shanghai Zhimeng Biopharma, Inc.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R (Canocapavir) in Combination With Nucleos(t)Ide Analog(NAs) Compared With NAs Monotherapy in Patients With Chronic Hepatitis B Who Have Received NAs Monotherapy for at Least 12 Months

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

1300

Start Date

2025-08

Completion Date

2030-01

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

DRUG

ZM-H1505R 100mg

ZM-H1505R(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks and Part B open-label extension period 144 weeks.

OTHER

ZM-H1505R Placebo

ZM-H1505R Placebo(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks.

COMBINATION_PRODUCT

NAs ("Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF") treatments

All eligible subjects will be use NAs ("Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF") treatments during the study for 148 weeks, including Part A and Part B. Subjects will continue to use the NAs as combination therapy before enrollment, the dosage will not be adjusted during the study. Subjects use in accordance with medical advice andinstructions.

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China