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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
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Ischemic Stroke Biological: Plasmin (Human) Phase 1 Phase 2

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.

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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:
  • TAL-05-00018
  • BAY-57-9602

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:
  • TAL-05-00018
  • BAY-57-9602

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:
  • TAL-05-00018
  • BAY-57-9602




Primary Outcome Measures :
  1. Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort [ Time Frame: 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Grifols Therapeutics LLC
Investigators
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Study Director: Jeffrey Saver, MD University of California, Los Angeles
Study Director: Peter Mitchell, MD Melbourne Health
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Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01014975    
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:
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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