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A Phase 2b, 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 Compared to Standard Neonatal Care in Extremely Premature Infants

Trial Profile

A Phase 2b, 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 Compared to Standard Neonatal Care in Extremely Premature Infants

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 14 Sep 2023

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At a glance

  • Drugs Mecasermin rinfabate (Primary)
  • Indications Bronchopulmonary dysplasia; Lung disorders
  • Focus Therapeutic Use
  • Sponsors Oak Hill Bio; Premacure; Shire; Takeda
  • Most Recent Events

    • 08 Jan 2023 This trial has been restarted in Portugal, according to European Clinical Trials Database record.
    • 19 Dec 2022 This trial has been restarted in Ireland, according to European Clinical Trials Database record.
    • 09 Dec 2022 Planned End Date changed from 28 Feb 2025 to 28 Nov 2026.
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