Status:
COMPLETED
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chron...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- Chronic HCV-infected males and non-pregnant/non-lactating females
- Treatment-naïve or treatment-experienced individuals
- Compensated cirrhosis at Screening
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04112303
Start Date
October 16 2019
End Date
June 25 2021
Last Update
April 20 2022
Active Locations (22)
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1
Chiba University Hospital
Chiba, Japan, 260-8677
2
Fukui-ken Saiseikai Hospital
Fukui, Japan, 918-8503
3
Japanese Red Cross Fukuoka Hospital
Fukuoka, Japan, 815-8555
4
Hiroshima University Hospital Institution Review Board
Hiroshima, Japan, 734-8551