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

NCT05734807 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-10-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Huahui Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2024-04-17
Completion
2024-04-17

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 NCT05734807 on ClinicalTrials.gov