A long-term study to follow patients infected with chronic Hepatitis C who received a Gilead Hepatitis C treatment in a Gilead clinical trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this Registry.
1. Have previously participated in a Gilead-sponsored chronic hepatitis C study as an adolescent or pediatric subject and received at least one Gilead HCV direct acting antiviral (DAA);
2. Parent or legal guardian able to provide written informed consent OR subject able to provide written informed consent and willing to comply with study requirements as determined by IRB/IEC/local requirements and Investigator’s discretion.
3. Subject able to provide written assent, if they have the ability to read and write, as determined by IRB/IEC/local requirements and Investigator’s discretion
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in this Registry.
1. Subject is currently receiving or plans to initiate a new course of hepatitis C therapyincluding any investigational drug or device during the course of the follow-up Registry.
2. History of clinically-significant illness or any other major medical disorder that may interferewith the 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: The primary objective of this Registry is:<br>- To determine the long-term safety of anti-HCV regimens in the pediatric population as determined by assessments of growth and<br>development.;Secondary Objective: The secondary objectives of this Registry are:<br>- To determine whether subsequent detection of HCV RNA in subjects who relapse following a sustained virologic response (SVR) represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection<br>- To characterize resistance mutations and the persistence of resistance mutations in pediatric subjects who did not achieve SVR;Primary end point(s): None. This is an observational study.;Timepoint(s) of evaluation of this end point: N/A

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None. This is an observational study.;Timepoint(s) of evaluation of this end point: N/A

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