Status:
COMPLETED
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, with chronic HCV genotype 1 infection
- Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR)
- Presence of compensated cirrhosis
- Screening laboratory values within defined thresholds
- Must use specific contraceptive methods if female of childbearing potential or sexually active male
- Not pregnant or a nursing female
Exclusion
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02226549
Start Date
July 1 2014
End Date
February 1 2015
Last Update
November 16 2018
Active Locations (1)
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1
San Antonio, Texas, United States