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

NCT06505928 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-23

No results posted yet for this study

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.

Conditions

  • Hepatitis D

Interventions

DRUG

hepalatide

hepalatide of 2.1 mg/d or 4.2mg/d s.c. treatment for 48 weeks

Sponsors & Collaborators

  • Shanghai HEP Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Oyunbileg Janchiv · National Cacer Center of Monglia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2026-05-31
Completion
2026-07-31

Countries

  • Mongolia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505928 on ClinicalTrials.gov