Trial Profile
Determination of the rhIGF-1/rhIGFBP-3 Dose, Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal Serum IGF-1 Levels Within Physiological Levels in Premature Infants, to Prevent Retinopathy of Prematurity A Phase 2, Randomized Controlled, Assessor-blind, Dose Confirming, Pharmacokinetic, Safety and Efficacy, Multicenter Study
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 07 Nov 2023
Price :
$35
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At a glance
- Drugs Mecasermin rinfabate (Primary)
- Indications Retinopathy of prematurity
- Focus Therapeutic Use
- Sponsors Premacure; Shire
- 13 Jun 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
- 12 Nov 2018 Results published in the Journal of Pediatrics
- 30 Jun 2016 Primary endpoint has not been met. (Severity of Retinopathy of Prematurity (ROP) as compared to the severity of ROP in an untreated control population. [ Time Frame: At term age (post menstrual week 40) ]), as reported in a Shire media release.