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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
Not Recruiting
Trial ID: NCT01701401
Purpose
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of
ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without
ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic
genotype 1 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 (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive 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-naive
- 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
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma (HCC) 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