A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
This study has been completed.
Sponsor:
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01014975
First received: November 16, 2009
Last updated: September 22, 2015
Last verified: September 2015
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Purpose
This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Ischemic Stroke |
Biological: Plasmin (Human) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Grifols Therapeutics Inc.:
Primary Outcome Measures:
- Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | November 2009 |
| Study Completion Date: | February 2014 |
| Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
Detailed Description:
This is a Phase 1/2a, open-label, multi-center, sequential dose escalation, safety study of Plasmin (Human) in acute ischemic stroke caused by middle cerebral artery occlusion documented by arteriography. Plasmin (Human) will be administered through a catheter into the thrombus within 9 hours of stroke onset. Approximately sixty-one (61) patients will be enrolled and will receive Plasmin (Human). The objectives of this study are to determine the safety of escalating doses of Plasmin (Human) and to determine the proportion of patients with treatment success, defined as partial or full recanalization.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014975
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014975
Locations
| 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 | |
Sponsors and Collaborators
Grifols Therapeutics Inc.
Investigators
| Study Director: | Jeffrey Saver, MD | University of California, Los Angeles |
| Study Director: | Peter Mitchell, MD | Melbourne Health |
More Information
| Responsible Party: | Grifols Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT01014975 History of Changes |
| Other Study ID Numbers: | T05018-1001 2010-019760-36 |
| Study First Received: | November 16, 2009 |
| Results First Received: | August 20, 2015 |
| Last Updated: | September 22, 2015 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration France: Ministry of Health Spain: Ministry of Health Austria: Austrian Medicines and Medical Devices Agency Serbia: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control |
Keywords provided by Grifols Therapeutics Inc.:
|
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 |
ClinicalTrials.gov processed this record on September 23, 2016