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)
Key facts
- Where
- Beijing, Chengdu, Guangzhou, Hangzhou, Shanghai, and Shenzhen, ChinaSee the 14 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06650852, who can take part
Where in China
- BeijingBeijing, ChinaTaking people
- BeijingBeijing, ChinaTaking people
- BeijingBeijing, ChinaTaking people
- BeijingBeijing, ChinaTaking people
- BeijingBeijing, ChinaTaking people
- ChengduChengdu, ChinaTaking people
- ChengduChengdu, ChinaTaking people
- ChengduChengdu, ChinaTaking people
- GuangzhouGuangzhou, ChinaTaking people
- GuangzhouGuangzhou, ChinaTaking people
- HangzhouHangzhou, ChinaTaking people
- ShanghaiShanghai, ChinaTaking people
- ShanghaiShanghai, ChinaTaking people
- ShenzhenShenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brii Biosciences Limited
- Trial code
- NCT06650852
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study; History of clinically significant chronic liver disease from any cause other than chronic HBV infection; History of hepatic decompensation; Current or past history of infection with HIV, HCV or HDV; Known history of immunological function impairment; History of intolerance to intramuscular or subcutaneous injection; Any laboratory test abnormality that may contradict treatment with PEG-IFNα; Significant liver fibrosis or cirrhosis; Diagnosed or suspected hepatocellular carcinoma.