Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/21/2018 |
Start Date: | July 2014 |
End Date: | November 2015 |
An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Study
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin
(RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have
participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve
sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification
(LLOQ) 24 weeks after last dose of study drug (SVR24).
of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin
(RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have
participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve
sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification
(LLOQ) 24 weeks after last dose of study drug (SVR24).
Key Inclusion Criteria:
- Willing and able to provide written informed consent
- Infection with HCV genotype 1
- HCV RNA > LLOQ at screening
- Participation in a prior Gilead-sponsored study
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or
sexually active male
- Must be of generally good health, with the exception of chronic HCV infection, as
determined by the Investigator
- Must be able to comply with the dosing instructions for study drug administration and
able to complete the study schedule of assessments
Key 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 (Groups 1 and 2 only)
- Hepatocellular carcinoma (HCC)
- History of clinically significant illness or any other medical disorder that may
interfere with subject treatment, assessment or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
38
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