A long-term study to follow patients infected with chronic Hepatitis C who did not achieve a cure following treatment in a Gilead clinical trial
- Conditions
- Genotype 1 Hepatitis C Virus InfectionMedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-000946-39-IT
- Lead Sponsor
- GILEAD SCIENCE INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 567
Willing and able to provide written informed consent; Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV; Have failed to achieve an SVR in that previous Gilead-sponsored study, as defined in the original treatment protocol; Have detectable DRMs results available from the previous Gilead-sponsored treatment protocol; Be willing and able to comply with the visit schedule and protocol-mandated procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 324
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
Subject is currently receiving or plans to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry; History of clinically-significant illness or any other major medical disorder that may interfere with subject follow-up, assessments or compliance with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate HCV viral sequences and the persistence of treatment emergent viral resistant mutations in subjects who fail to achieve SVR after treatment with an oral antiviral containing regimen in a Gilead-sponsored Hepatitis C Study.;Secondary Objective: To assess clinical progression of liver disease; To screen for the development of hepatocellular carcinoma (HCC).;Primary end point(s): None, this is a registry study.;Timepoint(s) of evaluation of this end point: N/a
- Secondary Outcome Measures
Name Time Method Secondary end point(s): None. This is a registry study;Timepoint(s) of evaluation of this end point: N/a