Hepatitis C
Conditions
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
Interventions
DRUGPeginterferon Lambda-1a (BMS-914143)
Observational study - No Intervention \[subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)\]
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Italy, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Romania, South Korea, Spain, United States
Outcome results
None listed