Status:
COMPLETED
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
Lead Sponsor:
Brii Biosciences Limited
Collaborating Sponsors:
Vir Biotechnology, Inc.
VBI Vaccines Inc.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV ...
Eligibility Criteria
Inclusion
- Male or female aged 18 - 60
- Body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2
- Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months
Exclusion
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- Significant fibrosis or cirrhosis
- History or evidence of drug or alcohol abuse
- History of intolerance to SC or IM injection
- History of chronic liver disease from any cause other than chronic HBV infection
- History of hepatic decompensation
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2023
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04749368
Start Date
April 12 2021
End Date
July 4 2023
Last Update
June 18 2024
Active Locations (28)
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1
Investigative Site 61002
Kingswood, New South Wales, Australia, 2747
2
Investigative Site 61001
Westmead, New South Wales, Australia, 2145
3
Investigative Site 61004
Herston, Queensland, Australia, 4029
4
Investigative Site 88602
Changhua, Taiwan, China, 500