Clinical Trial

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

Study acronym: L47-HD-MN
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated December 23, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-15; most recent amendment 2025-12-16.
Status change: Recruiting → Active, Not Recruiting 2025-12-16
Status change: Not Yet Recruiting → Recruiting 2024-12-11
Trial Details
NCT Number NCT06505928
Lead Sponsor Shanghai HEP Pharmaceutical Co., Ltd.
Conditions Hepatitis D
Enrollment 90 participants
Start Date 2024-12-11
Primary Completion 2026-05 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-12-23