NCT00418483View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

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.

Trial Locations (1)

43606

Jobst Vascular Institute, Toledo

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY