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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: ABT-450/ritonavir; Drug: ABT-267; Drug: ABT-333

Study type: Interventional

Funder types: Industry

Identifiers

NCT01773070

M13-102

2012-003073-26 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 478 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND.
• The interval between the last dose of the AbbVie DAA therapy from the previous clinical study and enrollment in Study M13-102 must be no longer than 2 years.
• The subject must voluntarily sign and date the informed consent form.
• Subject completed the post-treatment period of an eligible prior study.

Exclusion criteria

• The investigator considers the subject unsuitable for the study for any reasons.
• Receipt of any investigational product from Day 1 and while enrolled in this study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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478 participants in 1 patient group

All Participants

Other group

Description:

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.

Treatment:

Drug: ABT-333

Drug: ABT-267

Drug: ABT-450/ritonavir