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

Hypoplasminogenemia Clinical Trial

Official title:

A Single-patient Study of Repeat-dose Administration of ProMetic Plasminogen (Human) Intravenous Infusion in an Adult With Hypoplasminogenemia

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03265171
• Other study ID #: 2002C013G
• Status: No longer available

Study information

• Verified date: April 2020
• Source: Prometic Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 16 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoplasminogenemia

Intervention

Biological:
• Plasminogen (Human)

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Prometic Biotherapeutics, Inc.	Cedars-Sinai Medical Center, Indiana Hemophilia &Thrombosis Center, Inc., Vanderbilt University Medical Center