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 PrematurityA Phase II, Randomized Controlled, Assessor-Blind, Dose-Confirming, Pharmacokinetic, Safety and Efficacy, Multicenter Study - ROP Phase-II

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5月13日最近更新: 2016年12月5日

适应症

试验速览

暂无简介。

•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
•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

•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 (day of birth) to exclude severe congenital abnormalities of glucose metabolism
•5- Anticipated need of administration of erythropoietin (rhEPO) during treatment with study drug
•6- Any maternal diabetes requiring insulin during pregnancy
•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

发起方

Premacure AB, A member of the Shire Group of Companies