Status:
COMPLETED
Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained...
Eligibility Criteria
Inclusion
- Subjects must have received Lambda in a previous trial and have Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< LOQ at the completion of the required post-treatment follow-up (must enter this study within 6 months of completion of the required post-treatment follow-up in the previous trial) NOTE: For blinded parent trials, subjects who have HCV RNA \<LOQ at the completion of the required post-treatment follow-up may enter this study without knowledge of their treatment assignment in the parent study. Subjects who received control agents (eg, pegylated-interferon alfa) in the previous protocol will be allowed to participate until unblinded treatment information is released; at that time subjects will have the option to continue in the study
Exclusion
- Subjects must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of the previous study of Lambda
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01525810
Start Date
March 1 2012
End Date
November 1 2014
Last Update
March 26 2015
Active Locations (75)
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1
Scripps Clinic
La Jolla, California, United States, 92037
2
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510
3
Orlando Immunology Center
Orlando, Florida, United States, 32803
4
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States, 30060