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A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

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Trial Profile

A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Jul 2024

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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

    • 25 Jul 2024 This trial has been discontinued in Sweden.
    • 17 May 2024 According to a Oak Hill Bio media release, the first patient has been enrolled in a resumed Phase 2b clinical study to assess the efficacy and safety of OHB-607.
    • 13 May 2024 Planned End Date changed from 28 Nov 2026 to 21 Jan 2028.

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