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NCT02690714 · ClinicalTrials.gov registry record · Phase 2
A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
A Phase 2 study of Hypoplasminogenemia and Congenital Plasminogen Deficiency, sponsored by Prometic Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT02690714: Completed Phase 2 study of Hypoplasminogenemia and Congenital Plasminogen Deficiency, sponsored by Prometic Biotherapeutics.
NCT02690714 is a Phase 2 study of Hypoplasminogenemia and Congenital Plasminogen Deficiency that has completed, run by Prometic Biotherapeutics. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02690714, a Phase 2 study of Hypoplasminogenemia and Congenital Plasminogen Deficiency, has completed, sponsored by Prometic Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Overall clinical success was defined as 50% of participants with visible or other measurable lesions achieving at least a 50% improvement in lesion number/size or functionality impact from baseline. Visible lesions were defined as lesions that could be imaged and analyzed with digital photography. Non-visible lesions were defined as lesions whose dimensions could have been assessed by medical imaging studies (eg, computed tomography, magnetic resonance imaging, ultrasound, etc) or functional ass
Conditions Studied
Interventions
- BIOLOGICAL Plasminogen (Human) intravenous
Study Locations (2)
Indiana
- Indiana Hemophilia and Thrombosis Center - Indianapolis
Sognsvannvejen 20
- Oslo University Hospital HF - Oslo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-05-04 |
| Est. Completion | 2018-10-08 |
| Phase | Phase 2 |
What the finished NCT02690714 record still lists
NCT02690714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Hypoplasminogenemia appearing as the primary indexed condition, and to 1 intervention - of which Plasminogen (Human) intravenous is the first listed.
NCT02690714 reports a single indexed study location in Indiana, Sognsvannvejen 20.
Frequently Asked Questions
What is clinical trial NCT02690714 about?
NCT02690714 is a clinical study titled "A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia". 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.
What is the current status of trial NCT02690714?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2016-05-04. Estimated completion is 2018-10-08.
What conditions does trial NCT02690714 study?
This clinical trial studies the following conditions: Hypoplasminogenemia, Congenital Plasminogen Deficiency.
What interventions are being tested in trial NCT02690714?
The interventions under investigation include: Plasminogen (Human) intravenous (BIOLOGICAL).
Who is sponsoring clinical trial NCT02690714?
This trial is sponsored by Prometic Biotherapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02690714 being conducted?
This trial has 2 study locations across Indiana, Sognsvannvejen 20. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02690714's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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