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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773070
• Other study ID #: M13-102
• Secondary ID: 2012-003073-26
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2012
• Last updated: November 2, 2017
• Start date: June 2013
• Est. completion date: October 2016

Study information

• Verified date: November 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• ABT-450/ritonavir
ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.
• ABT-333
Drug is not administered -- this study is follow-up for participants previously receiving the drug.
• ABT-267
Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection	Relapse is defined as a confirmed HCV ribonucleic acid (RNA) = the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA = LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.	Up to 3 years post-treatment
Primary	Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B	The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in participants who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.	from the last dose of study drug in the previous study up to 3 years post-treatment
Secondary	Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection	Relapse is defined as a confirmed HCV RNA = LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.	From the end of treatment through 12 weeks post-treatment
Secondary	Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection	Relapse is defined as a confirmed HCV RNA = LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA = LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.	From the end of treatment through 24 weeks post-treatment
Secondary	Percentage of Participants Who Experienced Relapse?Overall Without and With New HCV Infection	Relapse is defined as a confirmed HCV RNA = LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse?overall was defined as a confirmed HCV RNA = LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.	Up to 3 years post-treatment