Status:
COMPLETED
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in particip...
Eligibility Criteria
Inclusion
- Infection with genotype 2 or 3 HCV infection
- Cirrhosis determination
- Individual is treatment-experienced
- Screening laboratory values within defined thresholds
- Individual has not been treated with any investigational drug or device within 30 days of the Screening visit
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion
- Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase
- Pregnant or nursing female or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the study protocol
- Excessive alcohol ingestion or significant drug abuse
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01808248
Start Date
February 1 2013
End Date
December 1 2013
Last Update
September 12 2014
Active Locations (1)
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1
Alamo Medical Research
San Antonio, Texas, United States, 78215