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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
Not Recruiting
Trial ID: NCT01768286
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
Stanford Investigator(s)
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Eligibility
Inclusion Criteria:
- 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:
- 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
Intervention(s):
drug: RBV
drug: LDV/SOF
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mindie H. Nguyen, MD
650-498-7878