A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

Completed

Phase 1/2 Results

Update History

22 Oct '15
The Summary of Purpose was updated.
New
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.
Old
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.
The description was updated.
New
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.
Old
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.
2 Aug '14
A location was updated in Heidelberg.
New
The overall status was removed for Heidelberg Repatriation Hospital, Melbourne.
A location was updated in Parkville.
New
The overall status was removed for Royal Melbourne Hospital.
A location was updated in Linz.
New
The overall status was removed for O.O. Landes-Nervenklinik Wagner-Jauregg.
A location was updated in Salzburg.
New
The overall status was removed for Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie.
A location was updated in Clermont-Ferrand.
New
The overall status was removed for Hôpital Gabriel Montpied.
A location was updated in Montpellier.
New
The overall status was removed for Hôpital Gui de Chauliac.
A location was updated in Paris.
New
The overall status was removed for Hôpital Bichat-Claude Bernard.
A location was updated in Toulouse.
New
The overall status was removed for Hôpital Rangueil.
A location was updated in Belgrade.
New
The overall status was removed for Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery.
A location was updated in Belgrade.
New
The overall status was removed for Special Hospital for Cerebrovascular Diseases "Sveti Sava".
A location was updated in Kragujevac.
New
The overall status was removed for Clinical Center Kragujevac, Center for Radiology Diagnostic.
A location was updated in Niš.
New
The overall status was removed for Clinical Center Niš, Center of Radiology.
A location was updated in Novi Sad.
New
The overall status was removed for Clinical Center of Vojvodina, Center for Radiology.
A location was updated in Banská Bystrica.
New
The overall status was removed for Neurology Clinic Hospital with Policlinic of F.D. Roosevelt.
A location was updated in Bratislava.
New
The overall status was removed for I. Neurology Clinic, University Hospital Bratislava.
A location was updated in Martin.
New
The overall status was removed for Radiology Clinic, University Hospital Martin.
A location was updated in Nitra.
New
The overall status was removed for Neurology Clinic, Faculty Hospital Nitra.
A location was updated in Ružomberok.
New
The overall status was removed for Neurology Clinic, Central Military Faculty Hospital.
A location was updated in L´Hospitalet de Llobregat.
New
The overall status was removed for Hospital Universitario de Bellvitge.
A location was updated in Badalona.
New
The overall status was removed for Hospital Universitario Germans Trias i Pujol.
A location was updated in Barcelona.
New
The overall status was removed for Hospital General Vall d'Hebron, Barcelona.
A location was updated in Madrid.
New
The overall status was removed for Hospital Universitario Ramón y Cajal.
A location was updated in Madrid.
New
The overall status was removed for Hospital General Universitario Gregorio Marañon.
17 Jan '14
The Summary of Purpose was updated.
New
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.
Old
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.
A location was updated in Heidelberg.
New
The overall status was removed for Heidelberg Repatriation Hospital, Melbourne.
A location was updated in Parkville.
New
The overall status was removed for Royal Melbourne Hospital.
A location was updated in Linz.
New
The overall status was removed for O.O. Landes-Nervenklinik Wagner-Jauregg.
A location was updated in Salzburg.
New
The overall status was removed for Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie.
A location was updated in Clermont-Ferrand.
New
The overall status was removed for Hôpital Gabriel Montpied.
A location was updated in Montpellier.
New
The overall status was removed for Hôpital Gui de Chauliac.
A location was updated in Paris.
New
The overall status was removed for Hôpital Bichat-Claude Bernard.
A location was updated in Toulouse.
New
The overall status was removed for Hôpital Rangueil.
A location was updated in Belgrade.
New
The overall status was removed for Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery.
A location was updated in Kragujevac.
New
The overall status was removed for Clinical Center Kragujevac, Center for Radiology Diagnostic.
A location was updated in Niš.
New
The overall status was removed for Clinical Center Niš, Center of Radiology.
A location was updated in Novi Sad.
New
The overall status was removed for Clinical Center of Vojvodina, Center for Radiology.
A location was updated in Banská Bystrica.
New
The overall status was removed for Neurology Clinic Hospital with Policlinic of F.D. Roosevelt.
A location was updated in Bratislava.
New
The overall status was removed for I. Neurology Clinic, University Hospital Bratislava.
A location was updated in Martin.
New
The overall status was removed for Radiology Clinic, University Hospital Martin.
A location was updated in Nitra.
New
The overall status was removed for Neurology Clinic, Faculty Hospital Nitra.
A location was updated in Ružomberok.
New
The overall status was removed for Neurology Clinic, Central Military Faculty Hospital.
A location was updated in L´Hospitalet de Llobregat.
New
The overall status was removed for Hospital Universitario de Bellvitge.
A location was updated in Badalona.
New
The overall status was removed for Hospital Universitario Germans Trias i Pujol.
A location was updated in Barcelona.
New
The overall status was removed for Hospital General Vall d'Hebron, Barcelona.
A location was updated in Madrid.
New
The overall status was removed for Hospital Universitario Ramón y Cajal.
A location was updated in Madrid.
New
The overall status was removed for Hospital General Universitario Gregorio Marañon.
14 Nov '12
A location was updated in Belgrade.
New
The overall status was removed for Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery.
A location was updated in Belgrade.
New
The overall status was removed for Special Hospital for Cerebrovascular Diseases "Sveti Sava".
A location was updated in Kragujevac.
New
The overall status was removed for Clinical Center Kragujevac, Center for Radiology Diagnostic.
A location was updated in Niš.
New
The overall status was removed for Clinical Center Niš, Center of Radiology.
A location was updated in Novi Sad.
New
The overall status was removed for Clinical Center of Vojvodina, Center for Radiology.
A location was updated in Banská Bystrica.
New
The overall status was removed for Neurology Clinic Hospital with Policlinic of F.D. Roosevelt.
A location was updated in L´Hospitalet de Llobregat.
New
The overall status was removed for Hospital Universitario de Bellvitge.
20 Jul '12
The Summary of Purpose was updated.
New
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.
Old
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 60 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.
The description was updated.
New
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.
Old
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. A maximum of seventy-five (75) patients will receive Plasmin (Human), a maximum of twenty-five (25) patients at each of the 3 dose levels (20 mg, 40 mg, and 60 mg). The objectives of this study are to determine the safety and tolerability of Plasmin (Human), to select a dose for further testing, and to determine the proportion of patients with partial or full recanalization.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. 18 to 85 years of age 2. Male or female 3. New focal, potentially disabling neurologic deficit clinically localized to the MCA distribution 4. Intra-arterial therapy with Plasmin completed within 9 hours of stroke onset 5. A National Institutes of Health Stroke Scale score ≥ 4 and ≤ 25 Exclusion Criteria: 1. Intracranial procedures or intracranial or systemic bleeding within the last year 2. Intracranial neoplasm (except meningioma), septic embolism, or unsecured aneurysm 3. Active bleeding 4. History of stroke in previous 6 weeks 5. Uncontrolled hypertension 6. Renal disease or renal dialysis 7. Treatment with any plasminogen activator within the last 48 hrs. 8. Therapy with a Glycoprotein IIb/IIIa inhibitor in 5 days prior to study enrollment or at any time during study
Old
Inclusion Criteria: 1. 18 to 85 years of age 2. Male or female 3. New focal, neurologic deficit in the MCA distribution due to occlusion of M1, M2 or M1-2 segments 4. Treatment within 8.5 hours of onset of symptoms 5. A National Institutes of Health Stroke Scale score ≥ 4 and ≤ 25 Exclusion Criteria: 1. Intracranial procedures or intracranial or systemic bleeding within the last year 2. Intracranial neoplasm (except meningioma), septic embolism, or unsecured aneurysm 3. Active bleeding or bleeding tendency 4. History of stroke in previous 6 weeks 5. Uncontrolled hypertension 6. Renal disease or renal dialysis 7. Previous treatment of the stroke with surgery, plasminogen activators, systemic heparin or Glycoprotein IIb/IIIa inhibitors
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: 1. 18 to 85 years of age 2. Male or female 3. New focal, neurologic deficit in the MCA distribution due to occlusion of M1, M2 or M1-2 segments 4. Treatment within 8.5 hours of onset of symptoms 5. A National Institutes of Health Stroke Scale score ≥ 4 and ≤ 25 Exclusion Criteria: 1. Intracranial procedures or intracranial or systemic bleeding within the last year 2. Intracranial neoplasm (except meningioma), septic embolism, or unsecured aneurysm 3. Active bleeding or bleeding tendency 4. History of stroke in previous 6 weeks 5. Uncontrolled hypertension 6. Renal disease or renal dialysis 7. Previous treatment of the stroke with surgery, plasminogen activators, systemic heparin or Glycoprotein IIb/IIIa inhibitors
Old
Inclusion Criteria: 1. 18 to 85 years of age 2. Male or female 3. New focal, neurologic deficit in the MCA distribution due to occlusion of M1, M2 or M1-2 segments 4. Treatment within 8.5 hours of onset of symptoms 5. A National Institutes of Health Stroke Scale score ? 4 and ? 25 Exclusion Criteria: 1. Intracranial procedures or intracranial or systemic bleeding within the last year 2. Intracranial neoplasm (except meningioma), septic embolism, or unsecured aneurysm 3. Active bleeding or bleeding tendency 4. History of stroke in previous 6 weeks 5. Uncontrolled hypertension 6. Renal disease or renal dialysis 7. Previous treatment of the stroke with surgery, plasminogen activators, systemic heparin or Glycoprotein IIb/IIIa inhibitors