Overview

This trial is active, not recruiting.

Condition hepatitis c virus infection
Treatments ldv/sof, rbv
Phase phase 3
Sponsor Gilead Sciences
Start date September 2015
End date November 2016
Trial size 255 participants
Trial identifier NCT02487030, GS-US-337-1643

Summary

This study will evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

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)
LDV/SOF for 8 weeks (treatment-naive (TN))
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
(Experimental)
LDV/SOF+RBV for 8 weeks (treatment-naive)
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
rbv
RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
(Experimental)
LDV/SOF for 12 weeks (treatment-naive)
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
(Experimental)
LDV/SOF+RBV for 12 weeks (treatment-naive)
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
rbv
RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
(Experimental)
Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
rbv
RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
(Experimental)
LDV/SOF for 12 weeks (treatment-experienced)
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
(Experimental)
LDV/SOF+RBV for 12 weeks (treatment-experienced)
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
rbv
RBV tablets administered orally in a divided daily dose based on weight (< 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
time frame: Up to 12 weeks

Secondary Outcomes

Measure
Proportion of participants with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
Proportion of participants with virologic failure
time frame: Up to Posttreatment Week 24

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Willing and able to provide written informed consent. - Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy - HCV genotype 4 at screening - HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only) - Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI) - Body mass index (BMI) ≥ 18 kg/m^2 - Screening laboratory values within defined thresholds - Use of effective protocol-approved contraception methods Key Exclusion Criteria: - History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) - Pregnant or nursing females or male with pregnant female partner - Clinically-relevant drug or alcohol abuse within 12 months of screening Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

Official title A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.