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 · NCT06650852 · Interventional (participants receive a specific treatment) · Lead sponsor: Brii Biosciences Limited
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
14 locations listed.
- Investigative Site 86001 - Beijing, Beijing Municipality, China
- Investigative Site 86003 - Beijing, Beijing Municipality, China
- Investigative Site 86004 - Beijing, Beijing Municipality, China
- Investigative Site 86005 - Beijing, Beijing Municipality, China
- Investigative Site 86016 - Beijing, Beijing Municipality, China
- Investigative Site 86002 - Guangzhou, Guangdong, China
- Investigative Site 86013 - Guangzhou, Guangdong, China
- Investigative Site 86015 - Shenzhen, Guangdong, China
- Investigative Site 86006 - Shanghai, Shanghai Municipality, China
- Investigative Site 86007 - Shanghai, Shanghai Municipality, China
- Investigative Site 86010 - Chengdu, Sichuan, China
- Investigative Site 86011 - Chengdu, Sichuan, China
- Investigative Site 86012 - Chengdu, Sichuan, China
- Investigative Site 86009 - Hangzhou, Zhejiang, China