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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01014975
First received: November 16, 2009
Last updated: July 31, 2014
Last verified: July 2014

November 16, 2009
July 31, 2014
November 2009
November 2013   (final data collection date for primary outcome measure)
Incidence of symptomatic intracranial hemorrhage (SICH) by dose cohort [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01014975 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Ischemic Stroke
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2014
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   France,   Serbia,   Slovakia,   Spain
 
NCT01014975
T05018-1001, 2010-019760-36
Yes
Grifols Therapeutics Inc.
Grifols Therapeutics Inc.
Not Provided
Study Director: Jeffrey Saver, MD University of California, Los Angeles
Study Director: Peter Mitchell, MD Melbourne Health
Grifols Therapeutics Inc.
July 2014

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