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

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

Completed
Phase of Trial: Phase II

Latest Information Update: 13 Sep 2017

At a glance

  • Drugs Mecasermin rinfabate (Primary)
  • Indications Retinopathy of prematurity
  • Focus Therapeutic Use
  • Sponsors Premacure; Shire
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 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.
    • 30 Jun 2016 Top-line results published in a Shire media release.
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