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

NCT ID: NCT01014975

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-02-28

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

20 mg Plasmin (Human)

20 mg of Plasmin (Human)

Group Type: EXPERIMENTAL

Plasmin (Human)

Intervention Type: BIOLOGICAL

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

40 mg Plasmin (Human)

40 mg of Plasmin (Human)

Group Type: EXPERIMENTAL

Plasmin (Human)

Intervention Type: BIOLOGICAL

Plasmin (Human), 40 mg, delivered through a catheter into a thrombus

80 mg Plasmin (Human)

80 mg of Plasmin (Human)

Group Type: EXPERIMENTAL

Plasmin (Human)

Intervention Type: BIOLOGICAL

Plasmin (Human), 80 mg, delivered through a catheter into a thrombus

Interventions

Plasmin (Human)

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

Intervention Type: BIOLOGICAL

Plasmin (Human)

Plasmin (Human), 40 mg, delivered through a catheter into a thrombus

Intervention Type: BIOLOGICAL

Plasmin (Human)

Plasmin (Human), 80 mg, delivered through a catheter into a thrombus

Intervention Type: BIOLOGICAL

Other Intervention Names

TAL-05-00018; BAY-57-9602; TAL-05-00018; BAY-57-9602; TAL-05-00018; BAY-57-9602

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Therapeutics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Saver, MD

Role: STUDY_DIRECTOR

University of California, Los Angeles

Peter Mitchell, MD

Role: STUDY_DIRECTOR

Melbourne Health

Locations

Heidelberg Repatriation Hospital, Melbourne

Heidelberg, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie

Salzburg, Salzburg, Austria

O.O. Landes-Nervenklinik Wagner-Jauregg

Linz, Upper Austria, Austria

Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Hôpital Gui de Chauliac

Montpellier, , France

Hôpital Bichat-Claude Bernard

Paris, , France

Hôpital Rangueil

Toulouse, , France

Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery

Belgrade, , Serbia

Special Hospital for Cerebrovascular Diseases "Sveti Sava"

Belgrade, , Serbia

Clinical Center Kragujevac, Center for Radiology Diagnostic

Kragujevac, , Serbia

Clinical Center Niš, Center of Radiology

Niš, , Serbia

Clinical Center of Vojvodina, Center for Radiology

Novi Sad, , Serbia

Neurology Clinic Hospital with Policlinic of F.D. Roosevelt

Banská Bystrica, , Slovakia

I. Neurology Clinic, University Hospital Bratislava

Bratislava, , Slovakia

Radiology Clinic, University Hospital Martin

Martin, , Slovakia

Neurology Clinic, Faculty Hospital Nitra

Nitra, , Slovakia

Neurology Clinic, Central Military Faculty Hospital

Ružomberok, , Slovakia

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

Hospital Universitario Germans Trias i Pujol

Badalona, , Spain

Hospital General Vall d'Hebron, Barcelona

Barcelona, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Countries

Australia; Austria; France; Serbia; Slovakia; Spain

Other Identifiers

2010-019760-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

T05018-1001

Identifier Type: -

Identifier Source: org_study_id