A Phase 2/3, Open-Label, Repeat-Dose Study of the Pharmacokinetics, Efficacy, and Safety of ProMetic Plasminogen Intravenous Infusion in Subjects With Hypoplasminogenemia
Phase of Trial: Phase II/III
Latest Information Update: 13 Oct 2017
At a glance
- Drugs Plasminogen (Primary)
- Indications Type I plasminogen deficiency
- Focus Registrational; Therapeutic Use
- Sponsors ProMetic Life Sciences
- 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.
- 11 Jul 2017 Long term data (n=10) from this trial published in a ProMetic Biosciences Media Release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History