A Treatment Protocol for Expanded Access Administration of Prometic Plasminogen Due to Closure of Clinical Trial
A Treatment Protocol for Extended Administration of Prometic Plasminogen (Human) by Intravenous Infusion in Subjects With Hypoplasminogenemia Requiring Plasminogen Replacement Therapy
1 other identifier
expanded_access
N/A
1 country
3
Brief Summary
The clinical trial is no longer enrolling and is currently closing and Prometic will continue to provide Plasminogen (Human) under a treatment protocol to subjects in the United States (US) with hypoplasminogenemia requiring plasminogen replacement therapy who completed the End of Study visit in the following Prometic-sponsored clinical trials: 2002C011G, 2002C013G, 2002C016G, 2002C017G and 2002C019G.
Trial Health
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3 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedDecember 9, 2022
December 1, 2022
August 10, 2018
December 8, 2022
Conditions
Interventions
Plasminogen IV replacement therapy
Eligibility Criteria
You may qualify if:
- Subjects must meet all the criteria below to participate in this study:
- 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).
- Subject has a diagnosis of hypoplasminogenemia requiring replacement therapy with Plasminogen (Human).
- 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.
- 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.
You may not qualify if:
- Subjects who are pregnant and/or lactating are excluded from participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Tower Hematology and Oncology
Beverly Hills, California, 90211, United States
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, 46260, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Lorber, MD
Tower Hematology, Oncology
- PRINCIPAL INVESTIGATOR
Heather McDaniel, MD
Vanderbilt Childrens Hospital
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2018
First Posted
August 22, 2018
Last Updated
December 9, 2022
Record last verified: 2022-12