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)
- Conditions
- Chronic Hepatitis B Virus (HBV) Infection
- Interventions
- Drug: BRII-835 (VIR-2218)Drug: Placebo of BRII-179Biological: PEG-IFNαDrug: Placebo of BRII-835
- Registration Number
- NCT06650852
- Lead Sponsor
- Brii Biosciences Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BRII-179 + BRII-835 + PEG-IFNα BRII-835 (VIR-2218) Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy. BRII-179 + BRII-835 + PEG-IFNα PEG-IFNα Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy. Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα Placebo of BRII-179 Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα. Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα Placebo of BRII-835 Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα. Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα PEG-IFNα Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα. BRII-179 + BRII-835 + PEG-IFNα BRII-179 Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy.
- Primary Outcome Measures
Name Time Method Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Up to 96 weeks The percentage of participants achieving HBsAg seroclearance. Up to 48 weeks
- Secondary Outcome Measures
Name Time Method Percentage of participants achieving HBsAg seroclearance. Up to 72 weeks Percentage of participants achieving functional cure. Up to 96 weeks Percentage of participants achieving HBsAg seroconversion. Up to 72 weeks
Trial Locations
- Locations (14)
Investigative Site 86002
🇨🇳Guangzhou, Guangdong, China
Investigative Site 86006
🇨🇳Shanghai, Shanghai, China
Investigative Site 86007
🇨🇳Shanghai, Shanghai, China
Investigative Site 86011
🇨🇳Chengdu, Sichuan, China
Investigative Site 86003
🇨🇳Beijing, Beijing, China
Investigative Site 86004
🇨🇳Beijing, Beijing, China
Investigative Site 86010
🇨🇳Chengdu, Sichuan, China
Investigative Site 86001
🇨🇳Beijing, Beijing, China
Investigative Site 86015
🇨🇳Shenzhen, Guangdong, China
Investigative Site 86005
🇨🇳Beijing, Beijing, China
Investigative Site 86016
🇨🇳Beijing, Beijing, China
Investigative Site 86013
🇨🇳Guangzhou, Guangdong, China
Investigative Site 86012
🇨🇳Chengdu, Sichuan, China
Investigative Site 86009
🇨🇳Hangzhou, Zhejiang, China