NCT01222117

A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion

A Phase 2, Randomized, Open-label (With Blinded Plasminogen Activator and Placebo Control Groups) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo In Patients With Acute Lower Extremity Native Artery or Bypass Graft Occlusion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. The study includes a blinded plasminogen activator treatment group and a blinded plasminogen activator placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250 mg doses.

Conditions

• Acute Peripheral Arterial Occlusion

Interventions

Type	Name	Description
BIOLOGICAL	Plasmin	Plasmin prepared in 0.9% saline for injection
BIOLOGICAL	Plasminogen Activator	Plasminogen activator used according to the Investigator's clinical judgment.
OTHER	Placebo	Normal saline for injection at the same volume as the plasminogen activator.

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2010-10-18
• Last updated: 2017-01-16
• Results posted: 2016-05-30

Locations

39 sites across 12 countries: United States, Belgium, Bulgaria, Czechia, Germany, India, Peru, Poland, Romania, Serbia, Slovakia, Spain