A Phase 2b/3, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age (CA) Compared to Standard Neonatal Care in Extremely Premature Infants

Trial Profile

A Phase 2b/3, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age (CA) Compared to Standard Neonatal Care in Extremely Premature Infants

Not yet recruiting
Phase of Trial: Phase II/III

Latest Information Update: 24 Aug 2017

At a glance

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

    • 15 Aug 2017 Status changed from planning to not yet recruiting.
    • 05 Jul 2016 New trial record
    • 30 Jun 2016 According to a Shire media release, the company expects to begin discussions with regulatory authorities about a phase 3 clinical program focusing on clinically relevant complications of prematurity.
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