Phase II multicenter trial regarding pharmacokinetics, safety and efficacy of continuous infusion of IGF-I to premature infants to prevent the onset of Retinopathy of Prematurity

Phase 1

Conditions: Retinopathy of Prematurity (ROP)
MedDRA version: 16.1Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2007-007872-40-IT

Lead Sponsor: Premacure AB, A member of the Shire Group of Companies

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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- 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