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

Recruiting

Phase 1/2 Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Plasmin (Human) Biological
    Other Names: TAL-05-00018; BAY-57-9602
    Intervention Desc: Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
    ARM 1: Kind: Experimental
    Label: 20 mg Plasmin (Human)
    Description: 20 mg of Plasmin (Human)
    ARM 2: Kind: Experimental
    Label: 40 mg Plasmin (Human)
    Description: 40 mg of Plasmin (Human)
    ARM 3: Kind: Experimental
    Label: 60 mg Plasmin (Human)
    Description: 60 mg of Plasmin (Human)
    ARM 4: Kind: Experimental
    Label: 80 mg Plasmin (Human)
    Description: 80 mg of Plasmin (Human)

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of symptomatic intracranial hemorrhage (SICH) by dose cohort 90 days Yes
Secondary Intracranial hemorrhage 90 days Yes
Secondary Major bleeding 90 days Yes
Secondary Minor bleeding 90 days Yes
Secondary Deaths 90 days Yes
Secondary Adverse events (serious and non-serious) 90 days Yes
Secondary Adverse events causing discontinuation of study drug 90 days Yes
Secondary Treatment-emergent, abnormal laboratory values 90 days Yes
Secondary 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. 60 minutes No
Secondary Incidence of all major and minor bleeding events 90 days Yes

Sponsors