A Phase 2/3, Open-Label, Repeat-Dose Study of the Pharmacokinetics, Efficacy, and Safety of ProMetic Plasminogen Intravenous Infusion in Subjects With Hypoplasminogenemia

Trial Profile

A Phase 2/3, Open-Label, Repeat-Dose Study of the Pharmacokinetics, Efficacy, and Safety of ProMetic Plasminogen Intravenous Infusion in Subjects With Hypoplasminogenemia

Completed
Phase of Trial: Phase II/III

Latest Information Update: 06 Dec 2017

At a glance

  • Drugs Plasminogen (Primary)
  • Indications Type I plasminogen deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors ProMetic Life Sciences
  • Most Recent Events

    • 06 Dec 2017 According to a ProMetic Life Sciences media release, 48-week long-term safety and efficacy data from the study will be presented at the 59th American Society of Hematology (ASH) Annual Meeting 2017.
    • 13 Oct 2017 According to a ProMetic Life Sciences media release, the U.S Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its plasminogen replacement therapy (RyplazimTM) and granted a priority review status with a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018.
    • 11 Jul 2017 According to a ProMetic Life Sciences media release, in addition to the dossier filed with the FDA, the 48-week clinicalefficacy data from this trial will form the basis for the upcoming regulatory filing with Health Canada in the fourth quarter of 2017.
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