Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
This trial is active, not recruiting.
|Condition||hepatitis c virus infection|
|Start date||September 2015|
|End date||November 2016|
|Trial size||255 participants|
|Trial identifier||NCT02487030, GS-US-337-1643|
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|
|Cairo, Egypt 11559||not available||no longer recruiting|
|Cairo, Egypt 11796||not available||no longer recruiting|
|Mansoura, Egypt||not available||no longer recruiting|
|Shebeen El-Kom, Egypt||not available||no longer recruiting|
|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
time frame: Up to 12 weeks
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
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.
|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|
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