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)

NCT06491563 · tracked via the Priya Life Science China tracker

Sponsor

Brii Biosciences Limited

Phase

Phase 2

Started

2024-08-06

Last updated

2024-12-30

Condition(s) studied

For Treatment of Chronic Hepatitis B Virus Infection

Investigational drug(s) / intervention(s)

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

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

Study summary

This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: * 1\. Male or female aged 18-60 years. * 2\. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * 3\. Chronic HBV infection for ≥ 6 months. * 4\. On NRTI therapy for ≥ 6 months. Exclusion Criteria: * 1\. Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation. * 2\. Significant liver fibrosis or cirrhosis. * 3\. History or evidence of drug or alcohol abuse. * 4\. History of intolerance to SC or IM injection. * 5\. History of chronic liver disease from any cause other than chronic HBV infection. * 6\. History of hepatic decompensation. * 7\. Contraindications to the use of PEG-IFNα.

Primary outcome measure(s)

Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint — 24 weeks post end of treatment

Trial sites (12)

Facility	City	Region
Investigative Site 86004	Beijing	Beijing Municipality
Investigative Site 86009	Beijing	Beijing Municipality
Investigative Site 86015	Xiamen	Fujian
Investigative Site 86012	Foshan	Guangdong
Investigative Site 86001	Guangzhou	Guangdong
Investigative Site 86013	Guangzhou	Guangdong
Investigative Site 86002	Shenzhen	Guangdong
Investigative Site 86003	Shanghai	Shanghai Municipality
Investigative Site 86008	Shanghai	Shanghai Municipality
Investigative Site 86007	Chengdu	Sichuan
Investigative Site 86011	Chengdu	Sichuan
Investigative Site 86005	Hangzhou	Zhejiang

More Brii Biosciences Limited trials in China

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) Recruiting

Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients Active, not 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 NCT06491563 on ClinicalTrials.gov ↗ ← All trials in China