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A Single-patient Study of Repeat-dose Administration of Prometic Plasminogen (Human) Intravenous

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: NCT03265171
Expanded Access Status : No longer available
First Posted : August 29, 2017
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
Cedars-Sinai Medical Center
Vanderbilt University Medical Center
Indiana Hemophilia &Thrombosis Center, Inc.
Information provided by (Responsible Party):
Prometic Biotherapeutics, Inc.

Brief Summary:
These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV infusion in one adult and one child with hypoplasminogenemia. These patients are under treatment to address wound healing and obstructions.

Condition or disease Intervention/treatment
Hypoplasminogenemia Biological: Plasminogen (Human)

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: A Single-patient Study of Repeat-dose Administration of ProMetic Plasminogen (Human) Intravenous Infusion in an Adult With Hypoplasminogenemia




Information from the National Library of Medicine

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Ages Eligible for Study:   16 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patient has provided informed consent.
  • Patient has a diagnosis of compound homozygous Type 1 plasminogen deficiency as evidence by ligneous conjunctivitis since birth as well as involvement of the conjunctiva, nasopharynx, gingiva, tracheobronchial tree, gastrointestinal tract, and urinary tract.

Exclusion Criteria:

  • Not applicable

No Contacts or Locations Provided
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Responsible Party: Prometic Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03265171    
Other Study ID Numbers: 2002C013G
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action