A Follow up Study Designed to Obtain Long Term Data on Subjects Who Either Achieved a Sustained Virologic Response or or Did Not Achieve a Sustained Virologic Response in an Abbott Sponsored Hepatitis C Study
A follow up study designed to obtain long term data on subjects who either achieved a sustained virologic response or did not achieve a sustained virologic response in an Abbott sponsored hepatitis C study.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Follow-up Study to Assess Resistance and Durability of Response to Abbott Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection|
- Durability of treatment response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]The percentage of subjects who relapse or have new hepatitis C infection at any time up to the last follow-up in this study out of subjects who achieved a 12-week Post-treatment sustained virologic response in the previous study and enroll in this study.
- Persistence of resistance mutations [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Evaluate the persistence of specific hepatitis C amino acid variants associated with drug resistance in subjects who experience virologic failure.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Follow-up study that includes sample collection procedures only and no treatment.
Drug is not administered -- this study is follow-up for subjects previously receiving the drug.Drug: ABT-333
Drug is not administered -- this study is follow-up for subjects previously receiving the drug.Drug: ABT-267
Drug is not administered -- this study is follow-up for subjects previously receiving the drug.
A follow-up study to assess resistance and durability of response to three experimental drugs ABT-450/r, ABT-267, and ABT-333 in subjects who have participated in Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C.
The other primary purpose of the study is to assess for durability of treatment response and assess for drug resistance.
|Contact: Melanie Gloria||1-847-936-0714||Melanie.Gloria@abbvie.com|
|Contact: Tiffany Larson, BS||1-847-937-1338||Tiffany.Larson@abbvie.com|
|Study Director:||Eoin Coakley, MD||AbbVie|