drugset / Trial / NCT06505928

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

NCT06505928

Phase 2 Active not recruiting 90 enrolled Shanghai HEP Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-11
Primary completion
2026-05
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Hepalatide Protein / enzyme biologic 2.1 mg Subcutaneous
Subject Hepalatide Protein / enzyme biologic 4.2 mg Subcutaneous