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



Status:Available
Healthy:No
Age Range:Any
Updated:8/24/2018
Contact:Amy Shapiro, MD
Email:ashapiro@IHTC.org
Phone:317-871-0000

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

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.

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.

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.
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Indianapolis, Indiana 46260
Phone: 317-871-0000
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