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A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

NCT06650852 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-05-23

No results posted yet for this study

Summary

This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Conditions

  • Chronic Hepatitis B Virus (HBV) Infection

Interventions

BIOLOGICAL

BRII-179

BRII-179 will be given via intramuscular injection

DRUG

BRII-835 (VIR-2218)

BRII-835 will be given via subcutaneous injection

BIOLOGICAL

PEG-IFNα

PEG-IFNα will be given via subcutaneous injection

DRUG

Placebo of BRII-179

Placebo of BRII-179 will be given via intramuscular injection

DRUG

Placebo of BRII-835

Placebo of BRII-835 will be given via subcutaneous injection

Sponsors & Collaborators

  • Brii Biosciences Limited

    lead INDUSTRY

Principal Investigators

  • Xiaofei Chen · Brii Biosciences Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-07-31
Completion
2027-07-31
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 NCT06650852 on ClinicalTrials.gov