Overview

This trial is active, not recruiting.

Condition hepatitis c virus infection
Treatments ldv/sof, sof, rbv
Phase phase 3
Sponsor Gilead Sciences
Start date April 2016
End date February 2017
Trial size 239 participants
Trial identifier NCT02738333, GS-US-337-1903

Summary

This study will evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 HCV (hepatitis C virus) infection.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
LDV/SOF FDC for 12 weeks
ldv/sof Harvoni®
90/400 mg FDC tablet administered orally once daily
(Experimental)
SOF+RBV for 12 weeks
sof Sovaldi®
400 mg tablet administered orally once daily
rbv REBETOL®
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg)
(Experimental)
Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.
ldv/sof Harvoni®
90/400 mg FDC tablet administered orally once daily

Primary Outcomes

Measure
Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
Proportion of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
time frame: Up to 12 weeks

Secondary Outcomes

Measure
Proportion of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
Proportion of Participants With HCV RNA < LLOQ by Visit While on Treatment
time frame: Up to 12 weeks
HCV RNA Change from Baseline
time frame: Baseline and up to 12 weeks
Proportion of Participants With Virologic Failure
time frame: Up to Posttreatment Week 24

Eligibility Criteria

All participants at least 20 years old.

Key Inclusion Criteria: - Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females - Aged 20 years or older - Treatment naive or treatment experienced - At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV. Key Exclusion Criteria: - Previous exposure to an NS5A or NS5B inhibitor - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) - Pregnant or nursing female or male with pregnant female partner Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

Official title A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Gilead Sciences.