EUCTR2014-004674-42-PL
Active, not recruiting
Phase 1
A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead Sponsored Chronic Hepatitis C Infection Trials
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gilead Sciences, Inc
- Enrollment
- 560
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 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
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 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.
Outcomes
Primary Outcomes
Not specified
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