Status:
COMPLETED
Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China
Lead Sponsor:
Brii Biosciences Limited
Collaborating Sponsors:
Vir Biotechnology, Inc.
Alnylam Pharmaceuticals
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.
Eligibility Criteria
Inclusion
- Male or female age 18 - 65;
- Weight ≥ 40 kg to ≤ 125 kg;
- 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 injection;
- History of chronic liver disease from any cause other than chronic HBV infection;
- History of hepatic decompensation;
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04507269
Start Date
August 18 2020
End Date
September 30 2021
Last Update
August 26 2024
Active Locations (2)
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1
Investigative Site
Beijing, Beijing Municipality, China
2
Investigative Site
Changchun, Jilin, China