EUCTR2014-003556-31-GB进行中（未招募）1 期
ong-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care
Premacure AB, A Member of the Shire Group of Companies0 个研究点目标入组 120 人开始时间: 2015年1月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
入选标准
- •Each subject must meet the following criteria to be enrolled in this study.
- •1. Subject was randomized in Study ROPP-2008-01, Section D
- •2. Subject’s parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. Study-related activities are any procedures that would not have been performed during normal management of the subject.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •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 criteria will be excluded from the study.
- •1. Any other condition or therapy that, in the Investigator’s opinion, may pose a risk to the
- •subject or interfere with the subject’s ability to be compliant with this protocol or interfere
- •with the interpretation of results
- •2. The subject or subject’s parent or legally authorized representative(s) is unable to comply
- •with the protocol as determined by the Investigator
研究者
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