EUCTR2014-004674-42-DEActive, not recruitingPhase 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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 560
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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: 560
- •F.1.2 Adults (18-64 years) no
- •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 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.
Investigators
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