NCT01773070

A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study

A Follow-up Study to Assess Resistance and Durability of Response to AbbVie 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	ABT-450/ritonavir	ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.
DRUG	ABT-333	Drug is not administered -- this study is follow-up for participants previously receiving the drug.
DRUG	ABT-267	Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-01-23
• Last updated: 2017-12-06
• Results posted: 2017-11-06