Status:
TERMINATED
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
F-star Therapeutics, Inc.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nuc...
Eligibility Criteria
Inclusion
- Key
- Groups 1-3 and 5:
- Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment
- Group 4:
- HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab.
- Have been on a commercially available HBV NUC treatment(s)
- Key
Exclusion
- Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV).
- Extensive bridging fibrosis or cirrhosis
- Evidence of hepatocellular carcinoma on imaging
- Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
- Chronic liver disease of a non-HBV etiology
- Current alcohol or substance abuse
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2021
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT03434353
Start Date
February 28 2018
End Date
January 26 2021
Last Update
April 4 2022
Active Locations (13)
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1
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hong Kong
2
Prince Margaret Hospital
Hong Kong, Hong Kong
3
Prince of Wales Hospital-HK
Hong Kong, Hong Kong
4
Korea University Ansan Hospital
Ansan, South Korea, 425-707