NL-OMON42210已完成2 期
Determination of the rhIGF-I/rhIGFBP-3 Dose; Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal SErum IGF-I Levels within Physiological Levels in Premature Infants, to prevent Retinopathy of Prematurity;A Phase II, Randomized Controlled, Assessor-Blind, Dose-Confirming, Pharmacokinetic, Safety and Efficacy, Multicenter Study - ROP Phase-II
MediServ0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •Each subject must meet the following criteria to be enrolled in this study:;1- A signed written informed consent from the subject's parents/guardians prior to any study-related procedures that has been approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ;2- Subject must be between GA of 26 weeks + 0 days and 27 weeks +6 days (Study Section A) or between GA of 23 weeks + 0 days and 27 weeks + 6 days (Study Sections B, C, and D), inclusive
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:;1- Subjects born small for gestational age (SGA), ie, weight at birth <-2 SDS (Study Section A only);2- Detectable gross malformation;3- Known or suspected chromosomal abnormality, genetic disorder, or syndrome, according to the investigator*s opinion;4- Persistent plasma glucose level <2.5 mmol/L or >10 mmol/L at Study Day 0 to exclude severe congenital abnormalities of glucose metabolism;5- Anticipated need of administration of erythropoietin (rhEPO) during treatment with study drug;6- Maternal history of gestational diabetes or any diabetes requiring insulin while pregnant;7- Clinically significant neurological disease according to the investigator*s opinion (Stage 1 IVH allowed);8- 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 interpretation of results;9- Monozygotic twins ;10- Subject participating or plans to participate in a clinical study of another investigational study drug
研究者
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