A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
Completed · Phase 2/Phase 3
Conditions studied: Hypoplasminogenemia, Congenital Plasminogen Deficiency
In brief
This is a Phase 2/3 pivotal study to evaluate pharmacokinetics (PK), efficacy, and safety of Prometic Plasminogen (Human) Intravenous Lyophilized Solution, the investigational medicinal product (IMP), in pediatric and adult subjects with hypoplasminogenemia.
Key facts
- Study ID
- NCT02690714
- Run by
- Prometic Biotherapeutics, Inc.
- People needed
- 15
- Starts
- 2016-05-04
- Expected to finish
- 2018-10-08
- Last updated by the study team
- 2021-08-02
Who can join
Age: 2 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is a male or female between the ages of 2 and 80 years (inclusive), is able to provide informed consent or assent, and agrees to use contraceptive methods during the study (unless documented as biologically or surgically sterile or has not reached reproductive age).
- Subject has documented history of hypoplasminogenemia and has plasminogen activity level ≤ 45%.
- Subject had a documented history of lesions and symptoms consistent with a diagnosis of congenital plasminogen deficiency.
- Subject has documented vaccination to hepatitis A virus (HAV) and hepatitis B virus (HBV), or has received the first dose of HAV and HBV vaccine prior to the first dose of IMP and is scheduled to receive the second vaccine dose.
You may not qualify if…
- Subject has uncontrolled hypertension; clinical or laboratory evidence of an intercurrent infection; a malignancy within 3 years, except for basal or squamous cell skin cancer; a psychiatric disorder; chronic or acute clinically significant inter-current illness; or evidence of renal and hepatic dysfunction.
- Subject is pregnant or lactating
- Subject has a history of anaphylactic reactions to blood or blood products that may interfere with participation in study in the opinion of the investigator.
- Subject is a previous organ transplant recipient; has received exogenous plasminogen within 2 weeks of the screening; has a history of anaphylactic reactions to blood or blood products; or has received another IRB-approved interventional clinical trial of a drug, biologic, or device within 30 days before the first dose of the IMP.
Where it is running
- Indiana Hemophilia and Thrombosis Center — Indianapolis, Indiana, United States
- Oslo University Hospital HF — Oslo, Sognsvannvejen 20, Norway
Full record on ClinicalTrials.gov
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