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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




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 the 150 mg dose.

Study Status: Recruiting

Timur Sarac, MD

Condition Intervention Phase
Acute Peripheral Arterial Occlusion Biological: Plasmin
Biological: Plasminogen Activator
Other: Placebo
Phase 2

Verified by Grifols Therapeutics Inc. March, 2013

Sponsored by: Grifols Therapeutics Inc.
Information provided by: Grifols Therapeutics Inc. identifier: NCT01222117

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Anthony J Comerota, MD., Study Chair
Victor Marder, MD., Study Chair
Richard Schlansky-Goldberg, MD., Study Chair

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