Evaluating a new combination therapy for chronic Hepatitis B infection
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 study is testing a new combination treatment for adults with chronic Hepatitis B who are already on medication to see if it works better than the standard treatment alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Brii Biosciences Limited Industry-sponsored |
| Locations | 14 sites (Beijing, Beijing Municipality and 13 other locations) |
| Trial ID | NCT06650852 on ClinicalTrials.gov |
What this trial studies
This Phase 2, randomized, double-blind study aims to assess the efficacy and safety of a combination therapy involving BRII-179, BRII-835, and PEG-IFNα in adults with chronic Hepatitis B virus (HBV) infection who are already on nucleos(t)ide reverse transcriptase inhibitors (NRTIs). Participants will be compared to a control group receiving PEG-IFNα alone. The study focuses on individuals without cirrhosis and evaluates the treatment's impact on HBV infection over time. The trial will involve multiple investigative sites in Beijing.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 with chronic HBV infection who have been on NRTI therapy for at least 6 months.
Not a fit: Patients with significant liver fibrosis, cirrhosis, or other chronic liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a more effective treatment option for patients with chronic Hepatitis B, potentially leading to better viral suppression and improved liver health.
How similar studies have performed: While this approach is being evaluated in this trial, similar combination therapies have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Beijing, Beijing Municipality and 13 other locations
- Investigative Site 86001 — Beijing, Beijing Municipality, China (Recruiting)
- Investigative Site 86003 — Beijing, Beijing Municipality, China (Recruiting)
- Investigative Site 86004 — Beijing, Beijing Municipality, China (Recruiting)
- Investigative Site 86005 — Beijing, Beijing Municipality, China (Recruiting)
- Investigative Site 86016 — Beijing, Beijing Municipality, China (Recruiting)
- Investigative Site 86002 — Guangzhou, Guangdong, China (Recruiting)
- Investigative Site 86013 — Guangzhou, Guangdong, China (Recruiting)
- Investigative Site 86015 — Shenzhen, Guangdong, China (Recruiting)
- Investigative Site 86006 — Shanghai, Shanghai Municipality, China (Recruiting)
- Investigative Site 86007 — Shanghai, Shanghai Municipality, China (Recruiting)
- Investigative Site 86010 — Chengdu, Sichuan, China (Recruiting)
- Investigative Site 86011 — Chengdu, Sichuan, China (Recruiting)
- Investigative Site 86012 — Chengdu, Sichuan, China (Recruiting)
- Investigative Site 86009 — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Clinical Research, Brii Biosciences
- Email: clinicaltrials@briibio.com
- Phone: +86 10 6299 8808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.