NCT06650852RecruitingPhase 2
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)
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)
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 12 Oct 2024
- Start date
- 31 Oct 2024
- Primary completion date
- Sept 2028
- Lead sponsor
- Brii Biosciences Limited
- Diseases
- Hepatitis B
- NCT number
- NCT06650852
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 250
- From 31 Oct 2024 to the primary completion date, Sept 2028
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Any laboratory test abnormality that may contradict treatment with PEG-IFNα.
Other
- Significant liver fibrosis or cirrhosis.
- Diagnosed or suspected hepatocellular carcinoma.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| - Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| - Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.