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

Study:

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

Rationale:

n/a

Purpose:

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

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.
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.