Premature male/female infants, between 26 weeks ±0 days and 29 weeks +6 days at birth, in risk of developing ROP, retinopathy of prematurity.
Conditions
Interventions
Trade Name: IPLEX, Insmed Therapeutic Proteins INC, USA
Product Name: rhIGF-1/rhIGFBP-3
Pharmaceutical Form: Solution for injection
INN or Proposed INN: mecasermin rinfabate
Sponsors
Ann Hellström
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: A) To determine the serum concentrations of intravenously administered rhIGFBP-3, B) To evaluate safety parameters ;Primary end point(s): Efficacy endpoints: Pharmacokintetic analyses of IGF-1 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. B) To determine the pharmacokinetic behavior of intra-venously administered rhIGF-I. | — |
Countries
Sweden
Outcome results
None listed