Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection

Trial ID or NCT#

NCT01768286

Status

not recruiting iconNOT RECRUITING

Purpose

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.

Official Title

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Age > 18, with chronic genotype 1 HCV infection - HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen - HCV RNA > 10,000 IU/mL at screening - Cirrhosis determination; a liver biopsy may be required - Screening laboratory values within defined thresholds - Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
  1. - Pregnant or nursing female or male with pregnant female partner - Coinfection with HIV or hepatitis B virus - Current or prior history of clinical hepatic decompensation - Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers) - 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
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Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Hepatologist, Transplant hepatologist
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

Contact us to find out if this trial is right for you.

Contact

Mindie H. Nguyen, MD
650-498-7878

View on ClinicalTrials.gov