NCT05734807

A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia

A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 in Nucleos(t)Ide Analogues-treated Chronic Hepatitis B Subjects With Low-Level Viremia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.

Conditions

• Chronic HBV Infection

Interventions

Type	Name	Description
DRUG	Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)	Subjects will receive NrtIs therapy for 24 weeks.
DRUG	HH-003 and NrtIs	Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.
DRUG	HH-003, NrtIs and PEG-IFN-α	Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.

Timeline

• Start date: 2022-07-20
• Primary completion: 2024-04-17
• Completion: 2024-04-17
• First posted: 2023-02-21
• Last updated: 2024-10-15

Locations

8 sites across 1 country: China