EUCTR2014-004674-42-PL进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 560
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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