Clinical trial NCT03642691: 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Hypoplasminogenemia
Lead sponsor: Prometic Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Hematology and Oncology
state: California
city: Indianapolis
country: United States
facility: Indiana Hemophilia and Thrombosis Center
state: Indiana
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Tower Hematology, Oncology
name: Jeremy Lorber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt Childrens Hospital
name: Heather McDaniel, MD
role: PRINCIPAL_INVESTIGATOR
References: