A Phase I, Open-Label, Pharmacokinetic, Single-Center, Dose Evaluation Study to Determine the Dose of rhIGF-I/rhIGFBP-3 required to Increase Serum IGF-I levels to Physiological Levels in Premature Infants - ROPP

• Conditions: Premature male/female infants, between 26 weeks ±0 days and 29 weeks +6 days at birth, in risk of developing ROP, retinopathy of prematurity.

• Registration Number: EUCTR2006-002500-34-SE
• Lead Sponsor: Ann Hellström

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1.Signed informed consent from parents/guardians
2.Subject must be between 26 weeks ±0 days and 29 weeks +6 days at birth;
3.Weight at birth > - 2 SD and < + 2 SD based on z score for age and gender

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

1.Present sepsis;
2.Detectable gross malformation;
3.Known or suspected chromosomal abnormality, genetic disorder, or syndrome, according to the investigator’s opinion;
4.IGF-I level =25 µg/L at study day 2;
5.Plasma glucose level <2.5 mmol/L or >10 mmol/L at study day 2;
6.Administration of insulin at any time during screening;
7.Administration of plasma later than 24 hours after birth;
8.Treatment with an experimental drug during screening;
9.Clinically significant neuropathy, nephropathy, retinopathy, or other micro- or macrovascular disease requiring treatment, according to the investigator’s opinion.
10.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: A) To determine the serum concentrations of intravenously administered rhIGFBP-3,<br><br>B) To evaluate safety parameters ;Primary end point(s): Efficacy endpoints: Pharmacokintetic analyses of IGF-1<br><br>Safety endpoints: Adverse events, hematology, clinical chemistry, retinal exam, physical examination, vital signs.;Main Objective: A) The objective of this study is to determine the dose of rhIGF-I/rhIGFBP-3 required to bring IGF-1 into the physiological range, defined as the in utero levels for corresponding gestational age in a normal population (20-50 µg/L), in ten premature (between 26 weeks ±0 days and 29 weeks +6 days gestation) infants.<br><br>B) To determine the pharmacokinetic behavior of intra-venously administered rhIGF-I.<br>