Status:
ACTIVE_NOT_RECRUITING
Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)
Lead Sponsor:
Brii Biosciences Limited
Collaborating Sponsors:
Vir Biotechnology, Inc.
Conditions:
For Treatment of Chronic Hepatitis B Virus Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)id...
Eligibility Criteria
Inclusion
- 1\. Male or female aged 18-60 years.
- 2\. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
- 3\. Chronic HBV infection for ≥ 6 months.
- 4\. On NRTI therapy for ≥ 6 months.
Exclusion
- 1\. Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
- 2\. Significant liver fibrosis or cirrhosis.
- 3\. History or evidence of drug or alcohol abuse.
- 4\. History of intolerance to SC or IM injection.
- 5\. History of chronic liver disease from any cause other than chronic HBV infection.
- 6\. History of hepatic decompensation.
- 7\. Contraindications to the use of PEG-IFNα.
Key Trial Info
Start Date :
August 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06491563
Start Date
August 6 2024
End Date
June 1 2027
Last Update
December 30 2024
Active Locations (12)
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1
Investigative Site 86004
Beijing, Beijing Municipality, China, 100000
2
Investigative Site 86009
Beijing, Beijing Municipality, China, 100000
3
Investigative Site 86015
Xiamen, Fujian, China, 361000
4
Investigative Site 86012
Foshan, Guangdong, China, 528000