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 ]
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