A Treatment Protocol for Expanded Access Administration of Prometic Plasminogen Due to Closure of Clinical Trial
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|ClinicalTrials.gov Identifier: NCT03642691|
Expanded Access Status : Available
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment|
US adult and pediatric subjects with hypoplasminogenemia requiring plasminogen replacement therapy who completed the End of Study visit in the following Prometic-sponsored clinical studies: 2002C011G, 2002C013G, 2002C016G, and 2002C017G will continue to receive their repeat-dose study of Plasminogen (Human) under a treatment protocol. Approximately, 15 subjects will be enrolled in the treatment protocol under an expanded access to continue to receive Plasminogen (Human) at a dose of 6.6 mg/kg as a 10 to 30-minute intravenous (IV) infusion at site visits or at home by either the subject or caregiver at the same frequency as in their prior Prometic-sponsored clinical study. Subjects or caregivers may be trained for study drug administration as deemed appropriate by the Investigator. Dosing frequency will be adjusted by the Investigator based on clinical response and plasminogen activity trough levels.
Subjects who completed the End of Study visit in studies 2002C011G, 2002C013G, 2002C016G, and 2002C017G 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.
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients, Intermediate-size Population, Treatment IND/Protocol|
|Official Title:||A Treatment Protocol for Extended Administration of Prometic Plasminogen (Human) by Intravenous Infusion in Subjects With Hypoplasminogenemia Requiring Plasminogen Replacement Therapy|
- Biological: Ryplazim
Plasminogen IV replacement therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642691
|Contact: Amy Shapiro, MD||317-871-0000||ashapiro@IHTC.org|
|United States, Indiana|
|Indiana Hemophilia and Thrombosis Center|
|Indianapolis, Indiana, United States, 46260|
|Contact: Amy Shapiro, M.D. 317-871-0000 ashapiro@IHTC.org|
|Contact: Neelam Thurkral 877-256-8837 email@example.com|