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NCT00418483 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion
A Phase 1 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
NCT00418483: Completed Phase 1 study, sponsored by Grifols Therapeutics.
NCT00418483 is a Phase 1 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 83 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00418483, a Phase 1 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography.
Primary Outcome
Thrombolysis at the end of treatment compared to baseline by arteriography
Interventions
- BIOLOGICAL Plasmin (Human) 25 mg
- BIOLOGICAL Plasmin (Human) 50 mg
- BIOLOGICAL Plasmin (Human) 75 mg
- BIOLOGICAL Plasmin (Human) 100 mg
- BIOLOGICAL Plasmin (Human) 125 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2007-03 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
What the finished NCT00418483 record still lists
NCT00418483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 5 interventions - of which Plasmin (Human) 25 mg is the first listed.
NCT00418483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00418483 about?
NCT00418483 is a clinical study titled "A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion". The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography.
What is the current status of trial NCT00418483?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2007-03. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00418483?
The interventions under investigation include: Plasmin (Human) 25 mg (BIOLOGICAL), Plasmin (Human) 50 mg (BIOLOGICAL), Plasmin (Human) 75 mg (BIOLOGICAL), Plasmin (Human) 100 mg (BIOLOGICAL), Plasmin (Human) 125 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00418483?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00418483's enrollment target sits among peer trials
83 665th of 2000 higher than 1,332 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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