A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-ActingAntiviral 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: 20.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-000452-24-DE
• 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: 2017-01-06
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To:<br>- Assess the durability of response for subjects who achieved SVR12 with a regimen including<br>ABT-493 and/or ABT-530.<br>- Assess the emergence and persistence of specific HCV amino acid variants associated with drug resistance in subjects who experience virologic failure.;Secondary Objective: To: <br>(1) Summarize medical events related to progression of liver disease including: events of hepatic decompensation, change in Child-Pugh classification, liver transplantation, hepatocellular carcinoma, death.<br>(2) Summarize results of the following laboratory tests and scores: Fibro Test, APRI, IP-10, alpha fetoprotein, FibroScan and liver biopsy.;Primary end point(s): Percentage of subjects who maintain a sustained virologic response; Assessing persistence of resistance-associated amino acid variants;Timepoint(s) of evaluation of this end point: Day 1, Month 3, Month 6 and every 6 months thereafter.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of medical events related to progression of liver disease; Participant Fibro Test score; Participant aspartate transaminase to platelet ratio index (APRI);Timepoint(s) of evaluation of this end point: Day 1, Month 3, Month 6 and every 6 months thereafter.