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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 16, 2009
First Posted Date  ICMJE November 17, 2009
Results First Submitted Date  ICMJE August 20, 2015
Results First Posted Date  ICMJE October 21, 2015
Last Update Posted Date October 21, 2015
Study Start Date  ICMJE November 2009
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2009)
Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2009)
  • Intracranial hemorrhage [ Time Frame: 90 days ]
  • Major bleeding [ Time Frame: 90 days ]
  • Minor bleeding [ Time Frame: 90 days ]
  • Deaths [ Time Frame: 90 days ]
  • Adverse events (serious and non-serious) [ Time Frame: 90 days ]
  • Adverse events causing discontinuation of study drug [ Time Frame: 90 days ]
  • Treatment-emergent, abnormal laboratory values [ Time Frame: 90 days ]
  • Thrombolytic activity - the proportion of patients with a score of Category 2a, 2b or 3 on the Thrombosis in Cerebral Infarction (TICI) scale as determined by the Central Reading Facility on 15-minute, 30-minute, or 60-minute arteriogram. [ Time Frame: 60 minutes ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
Official Title  ICMJE A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE
  • Biological: Plasmin (Human)
    Plasmin (Human), 20 mg, delivered through a catheter into a thrombus
    Other Names:
    • TAL-05-00018
    • BAY-57-9602
  • Biological: Plasmin (Human)
    Plasmin (Human), 40 mg, delivered through a catheter into a thrombus
    Other Names:
    • TAL-05-00018
    • BAY-57-9602
  • Biological: Plasmin (Human)
    Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
    Other Names:
    • TAL-05-00018
    • BAY-57-9602
Study Arms  ICMJE
  • Experimental: 20 mg Plasmin (Human)
    20 mg of Plasmin (Human)
    Intervention: Biological: Plasmin (Human)
  • Experimental: 40 mg Plasmin (Human)
    40 mg of Plasmin (Human)
    Intervention: Biological: Plasmin (Human)
  • Experimental: 80 mg Plasmin (Human)
    80 mg of Plasmin (Human)
    Intervention: Biological: Plasmin (Human)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2012)
40
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2009)
75
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   France,   Serbia,   Slovakia,   Spain
Removed Location Countries Germany,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01014975
Other Study ID Numbers  ICMJE T05018-1001
2010-019760-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grifols Therapeutics LLC
Study Sponsor  ICMJE Grifols Therapeutics LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jeffrey Saver, MD University of California, Los Angeles
Study Director: Peter Mitchell, MD Melbourne Health
PRS Account Grifols Therapeutics LLC
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP