Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:October 2012
End Date:January 2014

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection

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.


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
We found this trial at
1
site
Clinical Trial Facility in San Antonio Texas
San Antonio, Texas 78224
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