Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
This trial is active, not recruiting.
|Condition||hepatitis c virus infection|
|Treatments||ldv/sof, vdv, rbv|
|Start date||July 2014|
|End date||July 2015|
|Trial size||50 participants|
|Trial identifier||NCT02226549, GS-US-337-1512|
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) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
time frame: Posttreatment Week 12
Incidence of any adverse event leading to permanent discontinuation of study drug(s)
time frame: Up to 8 weeks
Proportion of participants with sustained virologic response 4 weeks after discontinuation of therapy (SVR4)
time frame: Posttreatment Week 4
Male or female participants at least 18 years old.
Inclusion Criteria: - Age ≥ 18 years, with chronic HCV genotype 1 infection - Documentation as treatment experienced having received PEG+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 Criteria: - 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
|Official title||A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis|
Call for more information