Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatments abt-450/ritonavir, abt-333, abt-267
Phase phase 3
Sponsor AbbVie (prior sponsor, Abbott)
Start date June 2013
End date October 2016
Trial size 500 participants
Trial identifier NCT01773070, 2012-003073-26, M13-102

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
Follow-up study that includes sample collection procedures only and no treatment.
abt-450/ritonavir
Drug is not administered -- this study is follow-up for subjects previously receiving the drug.
abt-333
Drug is not administered -- this study is follow-up for subjects previously receiving the drug.
abt-267
Drug is not administered -- this study is follow-up for subjects previously receiving the drug.

Primary Outcomes

Measure
Durability of treatment response
time frame: Up to 3 years
Persistence of resistance mutations
time frame: Up to 3 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AbbVie.