Evaluating a new combination therapy for chronic Hepatitis B infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

Study contacts

• Study coordinator: Clinical Research, Brii Biosciences
• Email: clinicaltrials@briibio.com
• Phone: +86 10 6299 8808

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating new biomarkers for chronic Hepatitis B infection management

  This study is testing new blood markers to see if they can help doctors better manage chronic Hepatitis B and predict serious health issues for patients receiving care at a hospital.

  Recruiting Assistance Publique - Hôpitaux de Paris · Créteil, Créteil · NCT06906016

• Non-invasive approach to assess liver fibrosis in chronic hepatitis B patients

  This study is testing a new way to see if liver stiffness measurements can help predict if liver damage improves in people with chronic hepatitis B who have been treated with antiviral therapy.

  Recruiting Beijing Friendship Hospital · Beijing · NCT06874127

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.