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A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B

NCT04426968 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-01-27

No results posted yet for this study

Summary

A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects with Chronic Hepatitis B

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Hepalatide 2.1mg

2.1 mg/day subcutaneously (s.c.) for 24 week

DRUG

Hepalatide 4.2mg

4.2mg/day subcutaneously (s.c.) for 24 week

DRUG

Hepalatide 6.3mg

6.3mg/day subcutaneously (s.c.) for 24 week

DRUG

placebo 2.1mg

2.1 mg/day subcutaneously (s.c.) for 24 week

DRUG

placebo 4.2mg

4.2 mg/day subcutaneously (s.c.) for 24 week

DRUG

placebo 6.3mg

6.3 mg/day subcutaneously (s.c.) for 24 week

DRUG

Pegylated Interferon

180 ug/week subcutaneously (s.c.) for 28 week

Sponsors & Collaborators

  • Shanghai HEP Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fusheng Wang · The fifth medical center of PLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-18
Primary Completion
2023-11-01
Completion
2023-11-29

Countries

  • China

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 NCT04426968 on ClinicalTrials.gov