A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infectio

Phase 1

• Conditions: Hepatitis C Virus; MedDRA version: 20.0 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-000452-24-BE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-15
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1. Subject has received at least 1 dose of an ABT-493 and/or ABT-530 containing regimen in a prior AbbVie HCV Phase 2 or 3 study which has been conducted under US IND.
2. Interval between last dose of AbbVie ADD therapy from the previous study and enrollment in M13-576 must be no longer than 2 years.
3. The subject must voluntarily sign/date the informed consent form approved by an IRB/EC prior to the initiation of any study-specific procedures.
4. Subject completed the post-treatment period of an eligible prior study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 390
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Investigator considers the subject unsuitable for the study for any reasons.
2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study.
3. Subject who experienced non-virologic treatment failure due to premature discontinuation of study drug in the prior study of ABT-493 and/or ABT-530.
4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failures in the prior Phase 2 or 3 study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified