A Treatment Protocol for Expanded Access Administration of Prometic Plasminogen Due to Closure of Clinical Trial
NCT ID: NCT03642691
Last Updated: 2022-12-09
Study Results
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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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Subjects who completed the End of Study visit in studies 2002C011G, 2002C013G, 2002C016G, 2002C017G and 2002C019G and signed informed consent (and assent, if applicable) for the present study will be enrolled in this study; this visit will be designated as Day 1 of the present study. Subjects will return to their study site every 26 weeks, or more often as determined by the Investigator, for safety assessments and measurements of plasminogen activity trough levels at the Investigator's discretion.
Treatment with Plasminogen (Human) will continue until the product has been approved and is commercially available or discontinued at any time by the Sponsor or at the discretion of the Investigator.
Conditions
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Interventions
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Ryplazim
Plasminogen IV replacement therapy
Eligibility Criteria
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Inclusion Criteria
1. The subject or the subject's caregiver has provided informed consent (as well as assent by subjects with ages dictated by local Investigational Review Board \[IRB\] guidelines).
2. Subject has a diagnosis of hypoplasminogenemia requiring replacement therapy with Plasminogen (Human).
3. Subject has completed the End of Study visit at a United States site in the following Prometic-sponsored clinical studies: 2002C011G, 2002C013G, 2002C016G, 2002C017G and 2002C019G.
4. Female and male subject agrees to use contraceptive methods from Day 1 through 14 days after last dose of study treatment (unless documented as biologically or surgically sterile \[e.g., postmenopausal, vasectomized\]), or has not reached reproductive age.
Exclusion Criteria
ALL
No
Sponsors
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Prometic Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremy Lorber, MD
Role: PRINCIPAL_INVESTIGATOR
Tower Hematology, Oncology
Heather McDaniel, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Childrens Hospital
Locations
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Tower Hematology and Oncology
Beverly Hills, California, United States
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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2002C018G
Identifier Type: -
Identifier Source: org_study_id