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

NCT03265171 | Unknown

• 1 other identifier: 2002C013G
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoplasminogenemia

Interventions

Plasminogen (Human) BIOLOGICAL

Eligibility Criteria

• Age: 16 Months+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Prometic Biotherapeutics, Inc.: lead
• Cedars-Sinai Medical Center: collaborator
• Vanderbilt University Medical Center: collaborator
• Indiana Hemophilia &Thrombosis Center, Inc.: collaborator

MeSH Terms

Conditions

Congenital Plasminogen Deficiency

Interventions

Plasminogen

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Beta-Globulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Protein Precursors

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Last Updated: April 24, 2020

Record last verified: 2020-04