IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
Completed · Phase 2
Conditions studied: Retinopathy of Prematurity (ROP)
In brief
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for gestational age at birth while confirming the dose of rhIGF-1/rhIGFBP-3 is safe and efficacious.
Key facts
- Study ID
- NCT01096784
- Run by
- Shire
- People needed
- 121
- Starts
- 2010-06-18
- Expected to finish
- 2016-03-30
- Last updated by the study team
- 2021-06-14
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent from parents/guardians;
- 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
You may not qualify if…
- Subjects born small for gestational age (SGA), ie, body weight at birth <-2 standard deviation score (SDS) (Study Section A only)
- Detectable gross malformation
- Known or suspected chromosomal abnormality, genetic disorder, or syndrome, according to the Investigator's opinion
- Persistent blood 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
- Anticipated need of administration of erythropoietin (rhEPO) during treatment with study drug.
- Any maternal diabetes requiring insulin during the pregnancy
- Clinically significant neurological disease according to the Investigator's opinion(Stage 1 IVH allowed)
- 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
- Monozygotic twins
- Subject participating or plans to participate in a clinical study of another investigational study drug
Where it is running
- University of South Alabama Children's and Women's Hospital — Mobile, Alabama, United States
- Univ of California Irvine Med Center — Irvine, California, United States
- Georgia Regents Medical Center — Augusta, Georgia, United States
- Univ of Mississippi Medical Center — Jackson, Mississippi, United States
- Vidant Medical Center — Greenville, North Carolina, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- West Virginia University Hospital — Morgantown, West Virginia, United States
- University of Wisconsin - Madison — Madison, Wisconsin, United States
- D.A.I. Materno Infantile, S.O.D. Neonatologia e Terapia Intensiva Neonatale - Azienda Ospedaliero-Universitaria Careggi — Florence, Italy
- U.O.C Patologia e Terapia Intensiva Neonatale, Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico — Genova, Italy
- University of Padua — Padua, Italy
- Dipartimento per la Tutella della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente-U.O.C. Neonatologia-Poli. Gemelli — Rome, Italy
- VU medical Center — Amsterdam, Netherlands
- Instytut Centrum Zdrowia Matki Polki — Lódz, Poland
- Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego w Poznani — Poznan, Poland
- Skånes University Hospital Lund — Lund, Sweden
- Karolinska Universtitetssjukhuset i Huddinge — Stockholm, Sweden
- Addenbrookes Hospital — Cambridge, United Kingdom
- St Peter's Hospital; Ashford & S — Chertsey, United Kingdom
- University Hospital — Coventry, United Kingdom
- Alder Hey Children's NHS Foundation Trust — Liverpool, United Kingdom
- UCL EGA Institute for Women's Health — London, United Kingdom
- St. Mary's Hospital — Manchester, United Kingdom
- Norfolk and Norwich University — Norwich, United Kingdom
Full record on ClinicalTrials.gov
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