Status:
COMPLETED
Phase 3 Study of Sofosbuvir and Ribavirin
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administer...
Eligibility Criteria
Inclusion
- Chronic Genotype 2 or 3 HCV-infection
- Naive to all HCV antiviral treatment(s)
Exclusion
- Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
- History of any other clinically significant chronic liver disease
- A history consistent with decompensated liver disease
- History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
- Participation in a clinical study within 3 months prior to first dose
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT01497366
Start Date
December 1 2011
End Date
April 1 2013
Last Update
April 2 2014
Active Locations (97)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Alabama Liver & Digestive Specialist
Montgomery, Alabama, United States, 36116
3
Franco Felizarta, MD
Bakersfield, California, United States, 93301
4
California Liver Institute
Beverly Hills, California, United States, 90210