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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 is a Phase 1 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 83 participants.

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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.

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

FieldValue
Enrollment Target 83 participants
Start Date 2007-03
Est. Completion 2010-04
Phase Phase 1

Sponsor

Grifols Therapeutics

34 total trials

What the Registry Record Tells You About NCT00418483

The ClinicalTrials.gov registry entry for NCT00418483 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Plasmin (Human) 25 mg is the first listed.

NCT00418483 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.