Long-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care (PEDAL)

Trial Profile

Long-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care (PEDAL)

Recruiting
Phase of Trial: Phase II

Latest Information Update: 18 Nov 2017

At a glance

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

    • 17 Nov 2016 Planned number of patients changed from 120 to 98.
    • 17 Nov 2016 Planned End Date changed from 1 Apr 2021 to 1 Sep 2021.
    • 17 Nov 2016 Planned primary completion date changed from 1 Jan 2021 to 1 Aug 2021.
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