Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT03642691 |
| Other study ID # |
2002C018G |
| Secondary ID |
|
| Status |
No longer available |
| Phase |
|
| First received |
|
| Last updated |
|
Study information
| Verified date |
December 2022 |
| Source |
Prometic Biotherapeutics, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Expanded Access
|
Clinical Trial 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.
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.
