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)

A Phase 2 Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and Pegylated Interferon Alpha (PEG-IFNα) in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06650852

Enrollment

250

Registered

2024-10-21

Start date

2024-10-31

Completion date

2027-07-31

Last updated

2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B Virus (HBV) Infection

Brief 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.

Interventions

BIOLOGICALBRII-179

BRII-179 will be given via intramuscular injection

DRUGBRII-835 (VIR-2218)

BRII-835 will be given via subcutaneous injection

BIOLOGICALPEG-IFNα

PEG-IFNα will be given via subcutaneous injection

DRUGPlacebo of BRII-179

Placebo of BRII-179 will be given via intramuscular injection

DRUGPlacebo of BRII-835

Placebo of BRII-835 will be given via subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Male or female aged 18-60 years. * Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * Chronic HBV infection for ≥ 6 months. * On NRTI therapy with HBV DNA \< LLOQ for ≥ 6 months. * Serum ALT and AST ≤ ULN at screening visit.

Exclusion criteria

* Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study. * Significant liver fibrosis or cirrhosis. * History of clinically significant chronic liver disease from any cause other than chronic HBV infection. * History of hepatic decompensation. * Diagnosed or suspected hepatocellular carcinoma. * Current or past history of infection with HIV, HCV or HDV. * Any laboratory test abnormality that may contradict treatment with PEG-IFNα. * Known history of immunological function impairment. * History of intolerance to intramuscular or subcutaneous injection.

Design outcomes

Primary

Measure	Time frame
The percentage of participants achieving HBsAg seroclearance.	Up to 48 weeks
Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).	Up to 96 weeks

Secondary

Measure	Time frame
Percentage of participants achieving HBsAg seroconversion.	Up to 48 weeks
Percentage of participants achieving HBsAg seroclearance.	Up to 72 weeks
Percentage of participants achieving functional cure.	Up to 96 weeks

Countries

China

Contacts

Primary ContactClinical Research, Brii Biosciences

clinicaltrials@briibio.com+86 10 6299 8808

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026