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Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
Not Recruiting
Trial ID: NCT01726517
Purpose
This study is to evaluate the safety, tolerability, and antiviral efficacy of
ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV),
administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis
C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had
previously received a regimen containing a protease inhibitor for the treatment of HCV.
Official Title
A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in 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 years, with chronic genotype 1 HCV infection
- HCV RNA equal to or greater than 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
- 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
650-498-7878