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A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion

NCT00418483 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2016-10-31

No results posted yet for this 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.

Conditions

  • Arterial Occlusive Diseases

Interventions

BIOLOGICAL

Plasmin (Human) 25 mg

Plasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

BIOLOGICAL

Plasmin (Human) 50 mg

Plasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

BIOLOGICAL

Plasmin (Human) 75 mg

Plasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

BIOLOGICAL

Plasmin (Human) 100 mg

Plasmin (Human) 100 mg

BIOLOGICAL

Plasmin (Human) 125 mg

Plasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

BIOLOGICAL

Plasmin (Human) 150 mg

Plasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

BIOLOGICAL

Plasmin (Human) 175 mg

Plasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Anthony J Comerota, MD · Jobst Vascular Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

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 NCT00418483 on ClinicalTrials.gov