Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial

Completed

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 virologic response

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

Subjects must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of the previous study of Lambda

Arm && Interventions

Group	Intervention	Description
Subjects treated with Peginterferon Lambda-1a (BMS-914143)	Peginterferon Lambda-1a (BMS-914143)	Subjects who participated in a clinical trial in which Peginterferon Lambda-1a (BMS-914143) was administered for the treatment of chronic hepatitis C

Primary Outcome Measures

Name	Time	Method
Durability of virologic response (time to loss of virologic response)	24 week intervals from end of treatment in parent study up to 144 weeks	Durability of virologic response as assessed by the time to loss of virologic response in subjects treated in a previous study with BMS-914143 who have HCV RNA less than the limit of quantitation of the assay (\< LOQ) at the completion of the required post-treatment follow-up in the previous study. Loss of virologic response assessed using HCV RNA at 24-week intervals

Secondary Outcome Measures

Name	Time	Method
Long-term progression of liver disease	24 week intervals up to 144 weeks	Long-term progression of liver disease as measured by laboratory indicators of hepatic status and function, all-cause mortality and liver related mortality in subjects previously treated with BMS-914143 who have HCV RNA \< LOQ at the completion of the required post-treatment follow-up in the parent study
Duration of persistence of anti-Lambda antibodies in subjects who are positive for anti-Lambda antibodies at end of treatment in the parent study	24 week intervals up to 144 weeks

Locations (19): Scripps Clinic
🇺🇸
La Jolla, California, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Gastrointestinal Specialists Of Georgia
🇺🇸
Marietta, Georgia, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Orlando Immunology Center
🇺🇸
Orlando, Florida, United States
Consultants For Clinical Research
🇺🇸
Cincinnati, Ohio, United States
Texas Clinical Research Institute
🇺🇸
Arlington, Texas, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
🇺🇸
Houston, Texas, United States
University Of Texas Health Science Center At Houston
🇺🇸
Houston, Texas, United States
Texas Liver Institute
🇺🇸
San Antonio, Texas, United States
Va Medical Center (151)
🇺🇸
Houston, Texas, United States
Metropolitan Research
🇺🇸
Annandale, Virginia, United States
Virginia Mason Medical Center
🇺🇸
Seattle, Washington, United States
Local Institution
🇪🇸
Valencia, Spain
Toronto Digestive Disease Associates, Inc.
🇨🇦
Vaughan, Ontario, Canada
Yale University School Of Medicine
🇺🇸
New Haven, Connecticut, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
The Queen'S Medical Center
🇺🇸
Honolulu, Hawaii, United States
Clinical Research Centers Of America
🇺🇸
Murray, Utah, United States