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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Ischemia Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thrombosis Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Heidelberg Repatriation Hospital, Melbourne, Heidelberg, Victoria, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 to 85 years of age
Male or female
New focal, potentially disabling neurologic deficit clinically localized to the MCA distribution
Intra-arterial therapy with Plasmin completed within 9 hours of stroke onset
A National Institutes of Health Stroke Scale score ≥ 4 and ≤ 25

Exclusion criteria

Intracranial procedures or intracranial or systemic bleeding within the last year
Intracranial neoplasm (except meningioma), septic embolism, or unsecured aneurysm
Active bleeding
History of stroke in previous 6 weeks
Uncontrolled hypertension
Renal disease or renal dialysis
Treatment with any plasminogen activator within the last 48 hrs.
Therapy with a Glycoprotein IIb/IIIa inhibitor in 5 days prior to study enrollment or at any time during study

Treatment and study plan

Plasmin (Human)

Biological

Plasmin (Human), 20 mg, delivered through a catheter into a thrombus

Other names: TAL-05-00018, BAY-57-9602

Primary outcomes

Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort

Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Grifols Therapeutics LLC

Industry

Registry information

Official study title

A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2014
First posted: Nov 17, 2009
Registry last updated: Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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