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
- Conditions
- 10047060premature retinopathyabnormal vasculair grow in the retina
- Registration Number
- NL-OMON42210
- Lead Sponsor
- MediServ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>*To determine the effect of rhIGF-1/rhIGFBP-3 on the severity of ROP as<br /><br>compared to the severity of ROP in an untreated control population.<br /><br>*To evaluate the dose of rhIGF-1/rhIGFBP-3, administered by continuous IV<br /><br>infusion, required to reach and maintain a physiological range of serum IGF-1<br /><br>of 28 to 109 µg/L, defined as the in utero levels of IGF-1 for corresponding GA<br /><br>in a normal population as described in Shire Reports 725-ROP-13-2103 and 725<br /><br>ROP 13-2113.<br /><br>*To determine serum concentrations of IGF-1 and associated pharmacokinetic<br /><br>parameters after continuous IV infusion of rhIGF-1/rhIGFBP-3.<br /><br>*To determine serum concentration of insulin-like growth factor binding protein<br /><br>3 (IGFBP-3) and acid labile subunit (ALS) after continuous IV infusion of rhIGF<br /><br>1/rhIGFBP-3.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine the effect of rhIGF-1/rhIGFBP-3 on other efficacy parameters and<br /><br>determine the safety profile of rhIGF-1/rhIGFBP-3 when compared with standard<br /><br>neonatal care in preterm infants. </p><br>