Overview

This trial is active, not recruiting.

Condition hepatitis c virus infection
Treatments ldv/sof, vdv, rbv
Phase phase 2
Sponsor Gilead Sciences
Start date July 2014
End date July 2015
Trial size 50 participants
Trial identifier NCT02226549, GS-US-337-1512

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) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive LDV/SOF+VDV for 8 weeks.
ldv/sof GS-5885
Ledipasvir 90 mg/sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
vdv GS-9451
Vedroprevir (VDV) 80 mg tablet administered orally once daily
(Experimental)
Participants will receive LDV/SOF+VDV+RBV for 8 weeks.
ldv/sof GS-5885
Ledipasvir 90 mg/sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
vdv GS-9451
Vedroprevir (VDV) 80 mg tablet administered orally once daily
rbv
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Proportion of participants with sustained virologic response 4 weeks after discontinuation of therapy (SVR4)
time frame: Posttreatment Week 4

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.