NCT05839639

A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors

A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B treated with nucleos(t)ide reverse transcriptase inhibitors.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	NrtIs	Subjects will receive NrtIs therapy for 24 weeks.
DRUG	HH-003	Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks.
DRUG	HH-003+NrtIs	Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks. Subjects will receive NrtIs therapy for 24 weeks.

Timeline

• Start date: 2021-10-09
• Primary completion: 2022-12-05
• Completion: 2023-05-17
• First posted: 2023-05-03
• Last updated: 2023-09-28

Locations

1 site across 1 country: China