Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C Virus Infection

In brief

The primary objectives of this study are to evaluate the effect of sustained virologic response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS) and on neurocognition as measured by neurocognitive tests. This study will also evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults. During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit, participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12 weeks.

Key facts

Study ID

NCT02219685

Run by

Gilead Sciences

People needed

40

Starts

2014-08-01

Expected to finish

2016-04-01

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
• Chronic genotype 1 HCV infection
• Screening laboratory values within defined thresholds
• Use of protocol-specified method(s) of contraception if female of childbearing potential or sexually active male

You may not qualify if…

• Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol. Current or prior history of any of the following:
• Hepatic decompensation
• Solid organ transplantation
• Significant pulmonary or cardiac disease
• Chronic liver disease of a non-HCV etiology
• Hepatocellular carcinoma (HCC)
• Infection with hepatitis B virus (HBV)
• Infection with human immunodeficiency virus (HIV)
• History of recent epilepsy (within 2 years of screening) or cerebral vascular accident (CVA)
• Structural brain damage
• Presence of cirrhosis
• Contraindication to MRI
• Pregnant or nursing female
• Prior treatment NS5A directly-acting antiviral agent. Any interferon (IFN)-containing regimen within 8 weeks of Screening

Where it is running

• Study site — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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