NCT00418483

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

A Sequential Phase I/II Dose Escalation and Dose Selection Safety Study of Regional Intra-thrombus Plasmin (Human) Infusion In Acute Lower Extremity Native Artery or Bypass Graft Occlusion

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There is an unmet need for proven thrombolytic agent in acute peripheral arterial occlusion (aPAO). The current assortment of plasminogen activators are slow to dissolve clots in the leg, and may lead to bleeding complications. Plasmin is a direct thrombolytic that may act more quickly when infused directly into the clot and thus assist in restoring blood flow to the leg. There is a large reserve in blood alpha-2 antiplasmin in the blood to rapidly inactivate Plasmin outside of the clot. Plasmin has the potential for an improved bleeding risk profile in aPAO.

Conditions

• Arterial Occlusive Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-01-04
• Last updated: 2016-10-31

Locations

1 site across 1 country: United States