Status:
COMPLETED
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, ...
Eligibility Criteria
Inclusion
- Chronic HCV-infection
- Naive to all HCV antiviral treatment
- Otherwise healthy patients
Exclusion
- Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- History of any other clinically significant chronic liver disease
- Medical history which the investigator considers the patient unsuitable for the study
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT01435044
Start Date
September 1 2011
End Date
May 1 2013
Last Update
February 6 2014
Active Locations (44)
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1
Alabama Liver & Digestive Specialists
Montgomery, Alabama, United States, 36116
2
Bakersfield, California, United States, 93301
3
Coronado, California, United States, 92118
4
La Mesa, California, United States, 91942