NCT04426968

A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B

A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined With Pegylated Interferon in Subjects With Chronic Hepatitis B

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects with Chronic Hepatitis B

Detailed description

The study is a 4-arm parallel design, randomized, double-blind, placebo-controlled, multicenter, dose-effect relationship, phase II clinical trial. The study is designed to assess efficacy and safety of 3 Doses of hepalatide in Combination with Pegylated Interferon Compared to Pegylated Interferon Alone in patients with Chronic Hepatitis B .Subjects will be randomly assigned to the 2.1mg, 4.2mg, and 6.3mg dose groups , 32 subjects in each group . The subjects in each dose group will be randomly and double-blindly administered the corresponding dose of trial drug or placebo in a ratio of 3:1. The subjects in each dose group who received placebo treatment combine as the placebo group. All subjects will receive Pegylated Interferon treatment for 28 weeks as the basic treatment,trial drug or placebo treatment for 24 weeks continuously , followed by a safety follow-up for 4 weeks.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Hepalatide 2.1mg	2.1 mg/day subcutaneously (s.c.) for 24 week
DRUG	Hepalatide 4.2mg	4.2mg/day subcutaneously (s.c.) for 24 week
DRUG	Hepalatide 6.3mg	6.3mg/day subcutaneously (s.c.) for 24 week
DRUG	placebo 2.1mg	2.1 mg/day subcutaneously (s.c.) for 24 week
DRUG	placebo 4.2mg	4.2 mg/day subcutaneously (s.c.) for 24 week
DRUG	placebo 6.3mg	6.3 mg/day subcutaneously (s.c.) for 24 week
DRUG	Pegylated Interferon	180 ug/week subcutaneously (s.c.) for 28 week

Timeline

• Start date: 2021-06-18
• Primary completion: 2023-11-01
• Completion: 2023-11-29
• First posted: 2020-06-11
• Last updated: 2025-01-27

Locations

12 sites across 1 country: China