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

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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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 10 Dec 2021

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At a glance

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

    • Most Recent Events

    • 20 Oct 2021 Results presented in a Kedrion Biopharma media release.
    • 04 Jun 2021 According to a Liminal BioSciences media release, based on the data of this study, the USA Food & Drug Administration (FDA) has approved Ryplazim (plasminogen, human-tvmh) for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia). Prometic Biotherapeutics is a holder of the biological license application (BLA) for Ryplazim.
    • 08 Nov 2020 According to a Liminal BioSciences media release, it will advance the date of the previously announced corporate update conference call and webcast to Wednesday November 11, 2020

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