A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
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ClinicalTrials.gov Identifier: NCT01014975 |
Recruitment Status
:
Completed
First Posted
: November 17, 2009
Results First Posted
: October 21, 2015
Last Update Posted
: October 21, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Ischemic Stroke | Biological: Plasmin (Human) | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | February 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: 20 mg Plasmin (Human)
20 mg of Plasmin (Human)
|
Biological: Plasmin (Human)
Plasmin (Human), 20 mg, delivered through a catheter into a thrombus
Other Names:
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Experimental: 40 mg Plasmin (Human)
40 mg of Plasmin (Human)
|
Biological: Plasmin (Human)
Plasmin (Human), 40 mg, delivered through a catheter into a thrombus
Other Names:
|
Experimental: 80 mg Plasmin (Human)
80 mg of Plasmin (Human)
|
Biological: Plasmin (Human)
Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
Other Names:
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- Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort [ Time Frame: 90 days ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 to 85 years of age
- Male or female
- New focal, potentially disabling neurologic deficit clinically localized to the MCA distribution
- Intra-arterial therapy with Plasmin completed within 9 hours of stroke onset
- A National Institutes of Health Stroke Scale score ≥ 4 and ≤ 25
Exclusion Criteria:
- Intracranial procedures or intracranial or systemic bleeding within the last year
- Intracranial neoplasm (except meningioma), septic embolism, or unsecured aneurysm
- Active bleeding
- History of stroke in previous 6 weeks
- Uncontrolled hypertension
- Renal disease or renal dialysis
- Treatment with any plasminogen activator within the last 48 hrs.
- Therapy with a Glycoprotein IIb/IIIa inhibitor in 5 days prior to study enrollment or at any time during study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014975
Australia, Victoria | |
Heidelberg Repatriation Hospital, Melbourne | |
Heidelberg, Victoria, Australia, 3084 | |
Royal Melbourne Hospital | |
Parkville, Victoria, Australia, 3050 | |
Austria | |
O.O. Landes-Nervenklinik Wagner-Jauregg | |
Linz, Upper Austria, Austria, 4020 | |
Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie | |
Salzburg, Austria, 5020 | |
France | |
Hôpital Gabriel Montpied | |
Clermont-Ferrand, France, 63003 | |
Hôpital Gui de Chauliac | |
Montpellier, France, 34295 | |
Hôpital Bichat-Claude Bernard | |
Paris, France, 75877 | |
Hôpital Rangueil | |
Toulouse, France, 31059 | |
Serbia | |
Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery | |
Belgrade, Serbia, 11000 | |
Special Hospital for Cerebrovascular Diseases "Sveti Sava" | |
Belgrade, Serbia, 11000 | |
Clinical Center Kragujevac, Center for Radiology Diagnostic | |
Kragujevac, Serbia, 34000 | |
Clinical Center Niš, Center of Radiology | |
Niš, Serbia, 18000 | |
Clinical Center of Vojvodina, Center for Radiology | |
Novi Sad, Serbia, 21000 | |
Slovakia | |
Neurology Clinic Hospital with Policlinic of F.D. Roosevelt | |
Banská Bystrica, Slovakia, 97517 | |
I. Neurology Clinic, University Hospital Bratislava | |
Bratislava, Slovakia, 813 69 | |
Radiology Clinic, University Hospital Martin | |
Martin, Slovakia, 03659 | |
Neurology Clinic, Faculty Hospital Nitra | |
Nitra, Slovakia, 95001 | |
Neurology Clinic, Central Military Faculty Hospital | |
Ružomberok, Slovakia, 036 26 | |
Spain | |
Hospital Universitario de Bellvitge | |
L´Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
Hospital Universitario Germans Trias i Pujol | |
Badalona, Spain, 08916 | |
Hospital General Vall d'Hebron, Barcelona | |
Barcelona, Spain, 08035 | |
Hospital General Universitario Gregorio Marañon | |
Madrid, Spain, 28007 | |
Hospital Universitario Ramón y Cajal | |
Madrid, Spain, 28034 |
Study Director: | Jeffrey Saver, MD | University of California, Los Angeles | |
Study Director: | Peter Mitchell, MD | Melbourne Health |
Responsible Party: | Grifols Therapeutics LLC |
ClinicalTrials.gov Identifier: | NCT01014975 History of Changes |
Other Study ID Numbers: |
T05018-1001 2010-019760-36 ( EudraCT Number ) |
First Posted: | November 17, 2009 Key Record Dates |
Results First Posted: | October 21, 2015 |
Last Update Posted: | October 21, 2015 |
Last Verified: | September 2015 |
Keywords provided by Grifols Therapeutics LLC:
stroke plasmin thrombus ischemic |
middle cerebral artery thrombolysis intra-arterial fibrin |
Additional relevant MeSH terms:
Stroke Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Pathologic Processes Fibrinolysin Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |