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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Treatment emergent adverse events [ Time Frame: Ongoing throughout 12 weeks ]
    Treatment emergent adverse events will be queried and reported continuously


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female between the ages of 2 and 80 years (inclusive).
  • Subject has a documented history of lesions and symptoms consistent with a diagnosis of hypoplasminogenemia
  • Subject has plasminogen activity level ≤ 45%.
  • 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 investigational drug and is scheduled to receive the second vaccine dose. If subject has documented vaccination more than 1 year before screening but has a negative antibody titer to HAV and/or HBV at screening, subject is required to begin a re-vaccination series with the first dose of HAV and/or HBV vaccine prior to the first dose of investigational drug and is scheduled to receive the second vaccine dose. No revaccination is required if the documented vaccination took place within 1 year of screening.

Exclusion Criteria:

  • Subject has a history of anaphylactic reactions to blood or blood products that may interfere with participation in the study in the opinion of the investigator.
  • Subject has uncontrolled hypertension.
  • Subject has clinical or laboratory evidence of an intercurrent infection as evidenced by symptoms including fever, tachycardia, or other systemic signs and symptoms.*
  • Subject is pregnant and/or lactating.
  • Subject has a malignancy, except for basal or squamous cell skin cancer, within 3 years before screening.
  • Subject is a previous organ transplant recipient.
  • Subject is in receipt of exogenous plasminogen (ocular or IV), such as laboratory grade plasminogen, fresh frozen plasma, or Plasminogen (Human) within 2 weeks of the first dose of the investigational drug.
  • Subject has a psychiatric disorder, other mental disorder, or any other medical disorder that impairs the subject's ability to provide informed consent or to comply with the requirements of the study protocol.
  • Subject has evidence of renal dysfunction defined as of > 2 X the upper limit of normal (ULN) in serum creatinine.
  • Subject has evidence of hepatic dysfunction defined as > 3 x ULN in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP).
  • Subject has participated in another institutional review board-approved interventional clinical trial of a drug, biologic, or device within 30 days before the first dose of the investigational drug.
  • Subject has a chronic or acute clinically significant intercurrent illness (e.g., cardiac, hepatic, renal, endocrine, neurologic, hematologic, neoplastic, immunological, and skeletal) that the investigator determines could interfere with the assessments in this study.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Indiana
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
ProMetic BioTherapeutics, Inc
Investigators
Principal Investigator: Amy Shapiro, MD Indiana Hemophilia & Thrombosis Center
More Information

Responsible Party: ProMetic BioTherapeutics, Inc
ClinicalTrials.gov Identifier: NCT02690714     History of Changes
Other Study ID Numbers: 2002C011G
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Coagulation Protein Disorders
Blood Coagulation Disorders
Hematologic Diseases
Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action