Status:
COMPLETED
A Phase 1 Study of ProMetic Plasminogen (Human) Intravenous in Adults and Children With Plasminogen Deficiency
Lead Sponsor:
Prometic Biotherapeutics, Inc.
Conditions:
Type I Plasminogen Deficiency
Hypoplasminogenemia
Eligibility:
All Genders
12-80 years
Phase:
PHASE1
Brief Summary
ProMetic is intiitating a first-in-man study entitled "A Phase 1, Dose Escalation, and Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults and Children with Hy...
Detailed Description
The Phase 1 study will be a single center study, the subjects will be from across country. It is an open-label, single-arm, dose-escalation study in patients with hypoplasminogenemia aged 12 years and...
Eligibility Criteria
Inclusion
- Subject has provided informed consent/assent, or the subject's guardian has given consent if the subject is under 18 years
- Subject is male or female between 12 and 80 years of age, inclusive
- Subject has a diagnosis of hypoplasminogenemia evidenced by an abnormal, decreased plasminogen activity level, regardless of plasminogen antigen level
- Subject has a plasminogen activity level ≤ 40%
- Subject has documented immunity to hepatitis A virus (HAV) and hepatitis B virus (HBV) or has received the first dose of HAV and HBV vaccine prior to IMP administration and is scheduled to receive the second vaccine dose
- Subject (male or female of reproductive age) agrees to use contraceptive methods from screening through 14 days after administration of IMP unless documented as biologically (e.g., post-menopausal, not begun menstruating) or surgically (vasectomized) sterile
Exclusion
- Subject has a history of severe reactions (e.g., anaphylaxis) to blood or blood products that may requiring resuscitation or otherwise prevent study participation in the opinion of the investigator
- Subject has evidence of uncontrolled hypertension
- Subject has clinical or laboratory evidence of an intercurrent infection as evidenced by symptoms including fever, tachycardia, or other specific signs and symptoms\*
- Subject is pregnant and/or lactating
- Subject has or has had a malignancy, except for basal and squamous cell skin cancer, within 3 years of Baseline
- Subject is a previous organ transplant recipient
- Subject is receiving exogenous plasminogen (ocular or IV), including laboratory grade plasminogen and fresh lyophilized plasma within two weeks of Baseline
- Subject has any psychiatric disorder, other mental disorder, or any other medical disorder that impairs the subject's ability to give informed consent or to comply with the requirements of the study protocol
- Subject has experienced a severe adverse event in a prior cohort of this study.
- Subject has evidence of renal dysfunction, defined as serum creatinine of \> 2 times the upper limit of normal
- Subject has evidence of hepatic dysfunction, defined as 3 times the upper limit of normal in ALT, and/or AST, and/or alkaline phosphatase (ALP)
- Subject has participated in another IRB-approved interventional clinical trial of a drug, biologic, or device within 30 days of Baseline
- Subject has a chronic or acute, clinically significant, inter-current illness (eg, cardiac, hepatic, renal, endocrine, neurologic, hematologic, neoplastic, immunological, and skeletal) that the investigator determines could interfere with the safety or pharmacokinetic assessments for this study
- Subject is unable to adhere to the scheduling requirements of the protocol \*Note: Subjects with an intercurrent infection cannot participate; however, subjects meeting this exclusion criterion at the Baseline Visit may return for a repeat Baseline Visit once the infection is considered resolved according to the investigator and can be included in the cohort that is actively recruiting at that time if all inclusion/exclusion criteria are met
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02312180
Start Date
December 1 2014
End Date
February 1 2016
Last Update
August 29 2017
Active Locations (1)
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1
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States, 46260