NCT05484466

A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB

A Phase IIa Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With Entecavir (ETV) Compared With ETV Monotherapy in Patients With Chronic Hepatitis B Who Have Received ETV Monotherapy for at Least 12 Months

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shanghai Zhimeng Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with HBV DNA \<2000 IU/mL but ≥ 50 IU/mL and who have received ETV (0.5 mg, once daily \[QD)\] monotherapy for at least 12 months. The study is planned to enroll 90 adult CHB subjects who have received ETV monotherapy for at least 12 months and are still receiving ETV monotherapy (0.5 mg, QD) continuously. Eligible subjects will be randomized in a 1:1:1 ratio into 3 treatment groups. Both HBeAg positive and negative subjects will be included. There will be 20 HBeAg positive subjects and 10 HBeAg negative subjects in each treatment group. After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week follow-up period for observation of efficacy and safety of ZM-H1505R.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with HBV DNA \<2000 IU/mL but ≥ 50 IU/mL and who have received ETV (0.5 mg, once daily \[QD)\] monotherapy for at least 12 months. The study is planned to enroll 90 adult CHB subjects who have received ETV monotherapy for at least 12 months and are still receiving ETV monotherapy (0.5 mg, QD) continuously. Eligible subjects will be randomized in a 1:1:1 ratio into 3 treatment groups. Both HBeAg positive and negative subjects will be included. There will be 20 HBeAg positive subjects and 10 HBeAg negative subjects in each treatment group. The treatment regimens in each group are as follows: Group A: ZM-H1505R 50 mg QD + Baraclude 0.5 mg QD Group B: ZM-H1505R 100 mg QD + Baraclude 0.5 mg QD Group C: ZM-H1505R placebo QD + Baraclude 0.5 mg QD After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week follow-up period for observation of efficacy and safety of ZM-H1505R.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	ZM-H1505R	There are three groups in this study. ZM-H1505R will be used in group A and Group B ，Subjects can use it for 48 weeks Group A: 30 subjects； ZM-H1505R 50 mg QD +ZM-H1505R placebo； Group B: 30 subjects； ZM-H1505R 100 mg QD
OTHER	ZM-H1505R placebo	There are three groups in this study. ZM-H1505R will be used in group A and Group C ，Subjects can use it for 48 weeks Group A: 30 subjects；ZM-H1505R 50 mg +ZM-H1505R placebo 50mg QD ； Group C: 30 subjects；ZM-H1505R placebo 100mg QD
COMBINATION_PRODUCT	Baraclude	All subjects were orally administered once a day at night ： Baraclude® 0.5 mg QD，60weeks

Timeline

• Start date: 2022-11-11
• Primary completion: 2022-12-20
• Completion: 2024-12-30
• First posted: 2022-08-02
• Last updated: 2023-05-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study