NCT05827146

Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

Double-blinded, Placebo-controlled, Munticenter, Phase IIa Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D

Detailed description

This is a four-arm parallel-group, randomized, placebo-controlled, double-blind, multicenter Phase IIa clinical trial. The CHD subjects who meet the eligibility criteria will be randomly assigned 1:1:1:1 to receive either the placebo or investigational drug (2.1 mg, 4.2 mg, or 6.3 mg), with 6 subjects per group . The placebo or the corresponding dose of the investigational drug will be given for 4 consecutive weeks, followed by a 4-week follow-up period. Subjects will be given entecavir for the treatment of hepatitis B infection during and after the end of the trial.

Conditions

• Chronic Hepatitis D Infection

Interventions

Type	Name	Description
DRUG	Hepalatide	Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.
DRUG	Hepalatide Placebo	Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.

Timeline

• Start date: 2023-10-07
• Primary completion: 2024-01-30
• Completion: 2024-02-01
• First posted: 2023-04-24
• Last updated: 2024-04-24

Locations

3 sites across 2 countries: China, Mongolia