Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
Trial ID or NCT#
Status
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.
Eligibility 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
- * 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
Investigator(s)
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Contact
Mindie H. Nguyen, MD
650-498-7878
View on ClinicalTrials.gov