Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C
Hepatitis C virus
Direct Acting Antiviral
Sustained Virologic Response
Hepatitis C
Persistence of treatment-emergent substitutions
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection
timeFrame: Up to 3 years post-treatment
measure: Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B
timeFrame: from the last dose of study drug in the previous study up to 3 years post-treatment
Secondary outcomes:
measure: Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection
timeFrame: From the end of treatment through 12 weeks post-treatment
measure: Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection
timeFrame: From the end of treatment through 24 weeks post-treatment
measure: Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection
timeFrame: Up to 3 years post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References: