NCT06505928

A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D

A Parallel-group, Randomized, Open-label Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D. Patients with compensated CHD who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into three groups at a 1:1:1 ratio. The subjects will receive continuous L47 (2.1 mg/d and 4.2 mg/d, s.c.) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). Primary endpoint evaluation will be performed after the subjects complete the 48-week treatment.

Detailed description

This is a three-arm, parallel-group, randomized, open-label, delayed-controlled phase IIb clinical trial. The study flow chart is shown in Fig. 1.2.1. CHD patients with compensated liver function who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into the 2.1 mg group, 4.2 mg group, and delayed treatment group at a 1:1:1 ratio (Table 1.1). The subjects will receive continuous L47 (2.1 mg/d and 4.2 mg/d, s.c.) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). The 1st interim analysis will be performed when all subjects complete the Week12 visit to determine the optimal dose for the extended treatment period following the trial. The 2nd interim analysis will be performed when all subjects complete the Week24 visit. Upon completion of the 48th week of treatment, the primary endpoint was assessed, and the trial was officially concluded. After the conclusion of the trial, all subjects in each group entered the extension treatment period and were all treated continuously with the L47 optimal dose for 96 weeks. After the extension treatment ended, all groups discontinued the medication and were observed for 48 weeks follow-up.

Conditions

• Hepatitis D

Interventions

Type	Name	Description
DRUG	hepalatide	hepalatide of 2.1 mg/d or 4.2mg/d s.c. treatment for 48 weeks

Timeline

• Start date: 2024-12-11
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2024-07-17
• Last updated: 2025-12-23

Locations

2 sites across 1 country: Mongolia