Status:
COMPLETED
Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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 neurocognitio...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02219685
Start Date
August 1 2014
End Date
April 1 2016
Last Update
November 16 2018
Active Locations (1)
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1
Boston, Massachusetts, United States