A follow up study designed to obtain long term data on subjects who either achieved a sustained virologic response or or did not achieve a sustained virologic response in an AbbVie sponsored hepatitis C study
- Conditions
- Hepatitis CMedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003073-26-CZ
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 478
1.The 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
2.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.
3.The subject must voluntarily sign and date the informed consent form approved by an Independent Review Board or Ethics Committee prior to the initiation of any study-specific procedures.
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 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
1. The investigator considers the subject unsuitable for the study for any reasons (e.g., failure to comply with study procedures in the prior AbbVie clinical study).
2. Receipt of any investigational product from Day 1 and while enrolled in this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objectives of this study are as follows:<br>?Assess the persistence of specific HCV amino acid variants associated with drug resistance in subjects who experience virologic failure. <br>?Assess the durability of response for subjects who achieved SVR12 with a regimen including an AbbVie DAA.<br>?Summarize results of IP-10, Fibrotest and Alpha-Fetoprotein tests. <br><br>;Secondary Objective: Not applicable.;Primary end point(s): Durability of treatment response.;Timepoint(s) of evaluation of this end point: Up to 3 years.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A