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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 80
Updated:10/14/2017
Start Date:June 2013
End Date:October 2016

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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

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.

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.

Inclusion Criteria:

- Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior
Abbott HCV Phase 2 or 3 study which is being submitted as a US IND.

- The interval between the last dose of the Abbott Direct-Acting Antiviral Agent 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.
We found this trial at
58
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Fort Pierce, FL
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Adelaide,
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Bradenton, FL
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Catonsville, MD
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Charlotte, North Carolina 28207
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Dothan, AL
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Egg Harbor Township, New Jersey 08234
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Egg Harbor Township, NJ
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Fayetteville, North Carolina 28304
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Springfield, Massachusetts 01199
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Statesville, North Carolina 28677
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