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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
Sponsor:
Information provided by (Responsible Party):
Prometic Biotherapeutics, Inc.

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, and 2002C017G.

Condition or disease Intervention/treatment
Hypoplasminogenemia Biological: Ryplazim

Detailed Description:

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.


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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



Intervention Details:
  • Biological: Ryplazim
    Plasminogen IV replacement therapy

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Subjects must meet all the criteria below to participate in this study:

    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, and 2002C017G
    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:

  • Subjects who are pregnant and/or lactating are excluded from participating in the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Amy Shapiro, MD 317-871-0000 ashapiro@IHTC.org

Locations
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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    nthukral@ihtc.org   
Sponsors and Collaborators
Prometic Biotherapeutics, Inc.

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Responsible Party: Prometic Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03642691     History of Changes
Other Study ID Numbers: 2002C018G
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action