NCT07095855

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Shanghai Zhimeng Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. \- Part A (Double-Blind Treatment Period): Eligible subjects will be randomized in a 1:1 ratio into 2 groups. Group A:ZM-H1505R 100mg +NAs Group B:ZM-H1505R placebo +NAs Two randomization stratification factors were set: NAs type of ETV, TDF,TAF, or TMF (no less than 15% of ETV, TDF, and TAF); HBV DNA \<2000 IU/mL and HBV DNA \>2000 IU/mL . All subjects completed a 48-week efficacy and safety evaluation followed by an interim analysis, the results of which were used to submit an NDA application. \- Part B (Open-Label Extension Period): At the end of the 48-week randomized double-blind treatment period, all eligible subjects will transfer to the open-label extension period and were treated with ZM-H1505R 100 mg +NAs while the study drug was evaluated for efficacy and safety until the end of the 144 weeks. \- Follow-up Period: At the end of the 144-week open-label extension period, all subjects will continue to take NAs, as a monotherapy for a 4-week follow-up period for observation of efficacy and safety of after discontinuation of study drug in ZM-H1505R .

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2025-07-31
• Last updated: 2025-08-03

Locations

1 site across 1 country: China