A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
This study is currently recruiting participants.
Verified March 2013 by Grifols Therapeutics Inc.
Sponsor:
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01014975
First received: November 16, 2009
Last updated: March 11, 2013
Last verified: March 2013
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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. 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 |
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 ]
Secondary Outcome Measures:
- Intracranial hemorrhage [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Major bleeding [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Minor bleeding [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Deaths [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Adverse events (serious and non-serious) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Adverse events causing discontinuation of study drug [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Treatment-emergent, abnormal laboratory values [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Incidence of all major and minor bleeding events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014975
Contacts
| Contact: David Fineberg, MD | david.fineberg@grifols.com |
Locations
| Australia, Victoria | |
| Heidelberg Repatriation Hospital, Melbourne | Recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Contact: Helen Dewey, MD 61394963705 helen.dewey@austin.org.au | |
| Principal Investigator: Helen M Dewey, MD | |
| Royal Melbourne Hospital | Recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Contact: Peter Mitchell, MD | |
| Contact: Bernard Yan, MD | |
| Principal Investigator: Peter Mitchell, MD | |
| Principal Investigator: Bernard Yan, MD | |
| Austria | |
| O.O. Landes-Nervenklinik Wagner-Jauregg | Recruiting |
| Linz, Upper Austria, Austria, 4020 | |
| Contact: Hans-Peter Haring, OA Univ.-Doz. Dr. 43505546229202 hanspeter.haring@gespag.at | |
| Principal Investigator: Hans-Peter Haring, MD. | |
| Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie | Recruiting |
| Salzburg, Austria, 5020 | |
| Contact: Monika Killer-Oberpfalzer, PD, Dr. 43662448356058 m.killer@salk.at | |
| Principal Investigator: Monika Killer-Oberpfalzer, PD, MD. | |
| France | |
| Hôpital Gabriel Montpied | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Pierre Clavelou | |
| Principal Investigator: Pierre Clavelou, MD | |
| Hôpital Gui de Chauliac | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Alain Bonafé, MD | |
| Principal Investigator: Alain Bonafé, MD | |
| Hôpital Bichat-Claude Bernard | Recruiting |
| Paris, France, 75877 | |
| Contact: Mikael Mazighi, MD | |
| Principal Investigator: Mikael Mazighi, MD | |
| Hôpital Rangueil | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Vincent Larrue, MD | |
| Principal Investigator: Larrue Vincent, MD | |
| Serbia | |
| Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery | Recruiting |
| Belgrade, Serbia, 11000 | |
| Contact: Lazar DAVIDOVIĆ,, MD, PhD 381 11 306 5176 davidovic.lazar@gmail.com | |
| Principal Investigator: Lazar DAVIDOVIĆ, MD, PhD | |
| Special Hospital for Cerebrovascular Diseases "Sveti Sava" | Recruiting |
| Belgrade, Serbia, 11000 | |
| Contact: Milan Savić, MD, PhD 381 11 6642831 milan.savic@svetisava.rs | |
| Principal Investigator: Milan Savić, MD, PhD | |
| Clinical Center Kragujevac, Center for Radiology Diagnostic | Recruiting |
| Kragujevac, Serbia, 34000 | |
| Contact: Milan MIJAILOVIĆ, MD, PhD 381 63 617 121 milankckragujevac@gmail.com | |
| Principal Investigator: Milan MIJAILOVIĆ, MD, PhD | |
| Clinical Center Niš, Center of Radiology | Recruiting |
| Niš, Serbia, 18000 | |
| Contact: Petar BOŠNJAKOVIĆ, MD, PhD 381 18 422 1469 petarbos@yahoo.com | |
| Principal Investigator: Petar BOŠNJAKOVIĆ, MD, PhD | |
| Clinical Center of Vojvodina, Center for Radiology | Recruiting |
| Novi Sad, Serbia, 21000 | |
| Contact: Viktor Till, MD, PhD 381 21 520 577 vtill@eunet.rs | |
| Principal Investigator: Viktor Till, MD, PhD | |
| Slovakia | |
| Neurology Clinic Hospital with Policlinic of F.D. Roosevelt | Recruiting |
| Banská Bystrica, Slovakia, 97517 | |
| Contact: Vladimir Donath, MD, PhD 421484130397 vdonath@istermet.sk | |
| Principal Investigator: Vladimir Donath, MD, PhD | |
| I. Neurology Clinic, University Hospital Bratislava | Recruiting |
| Bratislava, Slovakia, 813 69 | |
| Contact: Peter Turcani, MD, PhD 421 257 290 452 peter.turcani@sm.unb.sk | |
| Principal Investigator: Peter Turcani, MD, PhD | |
| Radiology Clinic, University Hospital Martin | Recruiting |
| Martin, Slovakia, 03659 | |
| Contact: Kamil Zelenak, MD, PhD 421 434 203 621 kamilzelenak@gmail.com | |
| Principal Investigator: Kamil Zelenak, MD, PhD | |
| Neurology Clinic, Faculty Hospital Nitra | Recruiting |
| Nitra, Slovakia, 95001 | |
| Contact: Miroslav Brozman, MD, PhD 42137 6545530 ext 337 brozman@fnnitra.sk | |
| Principal Investigator: Miroslav Brozman, MD, PhD | |
| Neurology Clinic, Central Military Faculty Hospital | Recruiting |
| Ružomberok, Slovakia, 036 26 | |
| Contact: Daniel Bartko, MD, PhD 421444382111 bartkod@uvn.sk | |
| Principal Investigator: Daniel Bartko, MD, PhD | |
| Spain | |
| Hospital Universitario de Bellvitge | Recruiting |
| L´Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Contact: Pere Cardona, MD 34670680068 pcardonap@bellvitgehospital.cat | |
| Principal Investigator: Pere Cardona, MD | |
| Hospital Universitario Germans Trias i Pujol | Recruiting |
| Badalona, Spain, 08916 | |
| Contact: Antoni Davalos | |
| Principal Investigator: Antoni Davalos, MD | |
| Hospital General Vall d'Hebron, Barcelona | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Marc Ribó Jacobi | |
| Principal Investigator: Marc Ribó Jacobi, MD | |
| Hospital Universitario Ramón y Cajal | Recruiting |
| Madrid, Spain, 28034 | |
| Contact: Jaime Masjuan | |
| Principal Investigator: Jaime Masjuan, MD | |
| Hospital General Universitario Gregorio Marañon | Not yet recruiting |
| Madrid, Spain, 28007 | |
| Contact: Antonio Gil Nuñez, MD 34915868339 agiln@meditex.es | |
| Principal Investigator: Antonio Gil Nuñez, MD | |
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
No publications provided
| 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 |
| Last Updated: | March 11, 2013 |
| 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:
|
Ischemia Stroke Cerebral Infarction Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Brain Infarction Brain Ischemia Fibrinolysin Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013