Clinical Trial: A Study of ProMetic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

Brief Summary:

This is a Phase 2/3 pivotal study of ProMetic Plasminogen (Human) Intravenous Lyophilized solution.

The primary objective of the study is to achieve a consistent increase of individual trough plasminogen activity levels.


Detailed Summary:
Sponsor: ProMetic BioTherapeutics, Inc

Current Primary Outcome: Plasma plasminogen activity trough levels [ Time Frame: 48 or 72 hours after infusion every 2 weeks for up to 12 weeks ]

Plasma samples will be taken 48 or 72 hours after infusion every 2 weeks to be analyzed for plasminogen activity levels


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Size of visible lesions by photographic evidence [ Time Frame: Every 2 weeks up to 12 weeks ]
    Visible lesions will be assessed by measuring the lesions in photographic images at clinic visits
  • Quality of Life survey (10-point scale) [ Time Frame: Every 2 weeks for up to 12 weeks ]
    A short survey using a 10-point scale (0 = non-functioning, 10 = normal) documenting patient reported quality of life will be assessed at clinic visits
  • Physicians Global Clinical Impression (7-point scale) [ Time Frame: Every 2 weeks for up to 12 weeks ]
    A 7-item scale documenting the physicians assessment of subject's disease status will be assessed at clinic visits
  • Treatment emergent adverse events [ Time Frame: Ongoing throughout 12 weeks ]
    Treatment emergent adverse events will be queried and reported continuously


Original Secondary Outcome: Same as current

Information By: ProMetic BioTherapeutics, Inc

Dates:
Date Received: February 12, 2016
Date Started: May 4, 2016
Date Completion: October 2017
Last Updated: March 2, 2017
Last Verified: March 2017