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

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Peginterferon Lambda-1a (BMS-914143)

• Registration Number: NCT01525810
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-03
• Study Start: 2012-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Trial Locations

Locations (19)

Scripps Clinic; 🇺🇸 La Jolla, California, United States

Yale University School Of Medicine; 🇺🇸 New Haven, Connecticut, United States

Orlando Immunology Center; 🇺🇸 Orlando, Florida, United States

Gastrointestinal Specialists Of Georgia; 🇺🇸 Marietta, Georgia, United States

The Queen'S Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Consultants For Clinical Research; 🇺🇸 Cincinnati, Ohio, United States

Texas Clinical Research Institute; 🇺🇸 Arlington, Texas, United States

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