A long-term study to follow patients infected with chronic Hepatitis C who received a Gilead Hepatitis C treatment in a Gilead clinical trial
- Conditions
- Chronic Hepatitis C virus infectionMedDRA version: 20.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-004674-42-PL
- Lead Sponsor
- Gilead Sciences, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 560
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 prior to any study procedures 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: 560
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 therapy including 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 interfere with 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: To determine the long-term safety of anti-HCV regimens in the pediatric population as determined by assessments of growth and development;Secondary Objective: - To determine whether subsequent detection of HCV RNA in subjects who relapse following 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><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