Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Hepatitis C virus Direct Acting Antiviral Sustained Virologic Response Hepatitis C Persistence of treatment-emergent substitutions
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 478
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.

Interventions: intervention 1: ABT-450/ritonavir intervention 2: ABT-333 intervention 3: ABT-267
Intervention descriptions: intervention 1: ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug. intervention 2: Drug is not administered -- this study is follow-up for participants previously receiving the drug. intervention 3: Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Protocol document: