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 now · Phase 2 · Has a placebo group
Conditions studied: Chronic Hepatitis B Virus (HBV) Infection
In brief
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.
Key facts
- Study ID
- NCT06650852
- Run by
- Brii Biosciences Limited
- People needed
- 250
- Starts
- 2024-10-31
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-05-23
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Investigative Site 86001 — Beijing, Beijing Municipality, China (enrolling)
- Investigative Site 86003 — Beijing, Beijing Municipality, China (enrolling)
- Investigative Site 86004 — Beijing, Beijing Municipality, China (enrolling)
- Investigative Site 86005 — Beijing, Beijing Municipality, China (enrolling)
- Investigative Site 86016 — Beijing, Beijing Municipality, China (enrolling)
- Investigative Site 86002 — Guangzhou, Guangdong, China (enrolling)
- Investigative Site 86013 — Guangzhou, Guangdong, China (enrolling)
- Investigative Site 86015 — Shenzhen, Guangdong, China (enrolling)
- Investigative Site 86006 — Shanghai, Shanghai Municipality, China (enrolling)
- Investigative Site 86007 — Shanghai, Shanghai Municipality, China (enrolling)
- Investigative Site 86010 — Chengdu, Sichuan, China (enrolling)
- Investigative Site 86011 — Chengdu, Sichuan, China (enrolling)
- Investigative Site 86012 — Chengdu, Sichuan, China (enrolling)
- Investigative Site 86009 — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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