A Treatment Protocol for Expanded Access Administration of Prometic Plasminogen Due to Closure of Clinical Trial

Brief Title

A Treatment Protocol for Expanded Access Administration of Prometic Plasminogen Due to Closure of Clinical Trial

Official Title

A Treatment Protocol for Extended Administration of Prometic Plasminogen (Human) by Intravenous Infusion in Subjects With Hypoplasminogenemia Requiring Plasminogen Replacement Therapy

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.
    

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, 2002C017G and 2002C019G 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,
      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.
    


Study Type

Expanded Access




Condition

Hypoplasminogenemia

Intervention

Ryplazim


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological





Eligibility 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,
                  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:

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

Gender

All

Ages

N/A - N/A


Contacts

Robert Decker, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03642691

Organization ID

2002C018G


Responsible Party

Sponsor

Study Sponsor

Prometic Biotherapeutics, Inc.


Study Sponsor

Robert Decker, MD, Principal Investigator, Tower Hematology, Oncology


Verification Date

February 2020