NCT05861674

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

A Multicenter, Randomized, Controlled, Open-label Phase IIb Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-06-16
• Primary completion: 2024-07-18
• Completion: 2025-06-21
• First posted: 2023-05-17
• Last updated: 2026-03-27

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study