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A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection

NCT05861674 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-03-27

No results posted yet for this study

Summary

This is a multicenter, randomized, controlled, open-label, Phase IIb study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to assess efficacy and safety in subjects with chronic hepatitis delta virus infection.

Conditions

  • Chronic Hepatitis Delta Virus Infection

Interventions

BIOLOGICAL

HH-003(20mg/kg)

20 mg/kg Q2W intravenously for 48 weeks

BIOLOGICAL

HH-003(10mg/kg)

10 mg/kg Q2W intravenously for 48 weeks

DRUG

TAF

TAF 25 mg QD orally during 48-week treatment period and 24-week follow-up period

Sponsors & Collaborators

  • Huahui Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2024-07-18
Completion
2025-06-21
FDA Drug
Yes

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 NCT05861674 on ClinicalTrials.gov