CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15 enrolled
Drug / intervention
Plasminogen (Human) intravenousbiological
Likely dose
Plasminogen (Human) intravenous 6.6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02690714
NCT02690714Phase 3Completed
CompareCT.gov

A Phase 2/3, Open-Label, Repeat-Dose Study of the Pharmacokinetics, Efficacy, and Safety of Prometic Plasminogen Intravenous Infusion in Subjects With Hypoplasminogenemia

Prometic Biotherapeutics, Inc.·interventional·Posted Feb 24, 2016·Updated Aug 2, 2021

In Brief

A Phase 3 clinical trial evaluating Plasminogen (Human) intravenous for Hypoplasminogenemia and Congenital Plasminogen Deficiency. Completed, enrolled 15 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoplasminogenemia, Congenital Plasminogen Deficiency
CountriesNorway, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 24, 2016
Enrollment StartMay 4, 2016
Primary CompletionDec 17, 2017
Study CompletionOct 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.4 years ago

Interventions

Plasminogen (Human) intravenousbiological

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.