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 · tracked via the Priya Life Science China tracker

Sponsor

Brii Biosciences Limited

Phase

Phase 2

Started

2024-10-31

Last updated

2025-05-23

Condition(s) studied

Chronic Hepatitis B Virus (HBV) Infection

Investigational drug(s) / intervention(s)

BRII-179BRII-835 (VIR-2218) →PEG-IFNα →Placebo of BRII-179Placebo of BRII-835

BRII-179: BRII-179 will be given via intramuscular injection

BRII-835 (VIR-2218): BRII-835 will be given via subcutaneous injection

PEG-IFNα: PEG-IFNα will be given via subcutaneous injection

Placebo of BRII-179: Placebo of BRII-179 will be given via intramuscular injection

Placebo of BRII-835: Placebo of BRII-835 will be given via subcutaneous injection

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

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.

Primary outcome measure(s)

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

Trial sites (14)

Facility	City	Region	Status
Investigative Site 86001	Beijing	Beijing Municipality	Recruiting
Investigative Site 86003	Beijing	Beijing Municipality	Recruiting
Investigative Site 86004	Beijing	Beijing Municipality	Recruiting
Investigative Site 86005	Beijing	Beijing Municipality	Recruiting
Investigative Site 86016	Beijing	Beijing Municipality	Recruiting
Investigative Site 86002	Guangzhou	Guangdong	Recruiting
Investigative Site 86013	Guangzhou	Guangdong	Recruiting
Investigative Site 86015	Shenzhen	Guangdong	Recruiting
Investigative Site 86006	Shanghai	Shanghai Municipality	Recruiting
Investigative Site 86007	Shanghai	Shanghai Municipality	Recruiting
Investigative Site 86010	Chengdu	Sichuan	Recruiting
Investigative Site 86011	Chengdu	Sichuan	Recruiting
Investigative Site 86012	Chengdu	Sichuan	Recruiting
Investigative Site 86009	Hangzhou	Zhejiang	Recruiting

More Brii Biosciences Limited trials in China

Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH) Active, not recruiting

Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients Active, not recruiting

Other trials for the same condition

Non-Invasive Model for Fibrosis Regression in HBV Patients Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06650852 on ClinicalTrials.gov ↗ ← All trials in China