A Study of ProMetic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02690714|
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Last Update Posted : August 29, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypoplasminogenemia||Biological: Plasminogen (human) intravenous||Phase 2 Phase 3|
Access to an investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 4, 2016|
|Primary Completion Date :||November 30, 2016|
|Estimated Study Completion Date :||October 2017|
Experimental: Plasminogen Intravenous repeat dose
Multiple dose of Plasminogen Intravenous will be administered to assess pharmacokinetics of plasminogen replacement and to study the therapeutics effects of the drug on symptoms of the disease.
Biological: Plasminogen (human) intravenous
ProMetic Plasminogen(human) intravenous
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690714
|United States, Indiana|
|Indiana Hemophilia and Thrombosis Center|
|Indianapolis, Indiana, United States, 46260|
|Principal Investigator:||Amy Shapiro, MD||Indiana Hemophilia & Thrombosis Center|