A Single-patient Study of Repeat-dose Administration of Prometic Plasminogen (Human) Intravenous
Sponsor
Prometic Biotherapeutics, Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT03265171
Collaborator
Cedars-Sinai Medical Center (Other), Vanderbilt University Medical Center (Other), Indiana Hemophilia &Thrombosis Center, Inc. (Other)
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Study Type:
Expanded Access
Official Title:
A Single-patient Study of Repeat-dose Administration of ProMetic Plasminogen (Human) Intravenous Infusion in an Adult With Hypoplasminogenemia
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Months
and Older
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Prometic Biotherapeutics, Inc.
- Cedars-Sinai Medical Center
- Vanderbilt University Medical Center
- Indiana Hemophilia &Thrombosis Center, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Prometic Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03265171
Other Study ID Numbers:
- 2002C013G
First Posted:
Aug 29, 2017
Last Update Posted:
Apr 24, 2020
Last Verified:
Apr 1, 2020
Additional relevant MeSH terms: