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A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia

NCT02690714 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-08-02

Study results available
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Summary

This is a Phase 2/3 pivotal study to evaluate pharmacokinetics (PK), efficacy, and safety of Prometic Plasminogen (Human) Intravenous Lyophilized Solution, the investigational medicinal product (IMP), in pediatric and adult subjects with hypoplasminogenemia.

Conditions

  • Hypoplasminogenemia
  • Congenital Plasminogen Deficiency

Interventions

BIOLOGICAL

Plasminogen (Human) intravenous

Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.

Sponsors & Collaborators

  • Prometic Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Amy Shapiro, MD · Indiana Hemophilia & Thrombosis Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-04
Primary Completion
2017-12-17
Completion
2018-10-08

Countries

  • United States
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02690714 on ClinicalTrials.gov