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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

NCT ID: NCT01773070

Last Updated: 2017-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-10-31

Brief Summary

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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

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Conditions

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Hepatitis C

Keywords

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Chronic Hepatitis C Hepatitis C virus Direct Acting Antiviral Sustained Virologic Response Hepatitis C Persistence of treatment-emergent substitutions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All Participants

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.

Group Type OTHER

ABT-450/ritonavir

Intervention Type DRUG

ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.

ABT-333

Intervention Type DRUG

Drug is not administered -- this study is follow-up for participants previously receiving the drug.

ABT-267

Intervention Type DRUG

Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Interventions

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ABT-450/ritonavir

ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Intervention Type DRUG

ABT-333

Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Intervention Type DRUG

ABT-267

Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Intervention Type DRUG

Other Intervention Names

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ABT-450 also known as paritaprevir dasabuvir ombitasvir

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

Countries

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Australia Belgium Canada Denmark Germany Ireland Netherlands New Zealand Puerto Rico Spain United Kingdom United States

Other Identifiers

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2012-003073-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-102

Identifier Type: -

Identifier Source: org_study_id