A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
This Registry is designed to obtain long term data on subject who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C study.
Hepatitis C, Chronic
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection|
- Viral Activity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]To characterize HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral (OAV) containing regimen in a previous Gilead-sponsored hepatitis C study
- Clinical progression of liver disease [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Clinical progression of liver disease will be assessed by review of clinical signs, symptoms and laboratory parameters (clinical chemistry, haematology, coagulation and alfa-feto protein).
- Development of hepatocellular carcinoma (HCC) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Screening for the development of HCC will comprise of review of clinical signs and symptoms and laboratory parameters including alfa-feto protein.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
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|Study Director:||John McNally||Gilead Sciences|