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ACTIVE NOT RECRUITING
NCT06505928
PHASE2

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

Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-12-11

Completion Date

2026-07

Last Updated

2025-12-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

hepalatide

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

Locations (2)

National cancer canter of Monglia

Ulaanbaatar, Mongolia

National Center for Communicable Diseases

Ulaanbaatar, Mongolia