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

NCT ID: NCT03265171

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoplasminogenemia

Interventions

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Plasminogen (Human)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Indiana Hemophilia &Thrombosis Center, Inc.

OTHER

Sponsor Role collaborator

Prometic Biotherapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2002C013G

Identifier Type: -

Identifier Source: org_study_id

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