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
2 other identifiers
interventional
40
5 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2009
Longer than P75 for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 16, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
October 21, 2015
CompletedOctober 21, 2015
September 1, 2015
4 years
November 16, 2009
August 20, 2015
September 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort
90 days
Study Arms (3)
20 mg Plasmin (Human)
EXPERIMENTAL20 mg of Plasmin (Human)
40 mg Plasmin (Human)
EXPERIMENTAL40 mg of Plasmin (Human)
80 mg Plasmin (Human)
EXPERIMENTAL80 mg of Plasmin (Human)
Interventions
Plasmin (Human), 20 mg, delivered through a catheter into a thrombus
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Heidelberg Repatriation Hospital, Melbourne
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie
Salzburg, Salzburg, 5020, Austria
O.O. Landes-Nervenklinik Wagner-Jauregg
Linz, Upper Austria, 4020, Austria
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003, France
Hôpital Gui de Chauliac
Montpellier, 34295, France
Hôpital Bichat-Claude Bernard
Paris, 75877, France
Hôpital Rangueil
Toulouse, 31059, France
Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery
Belgrade, 11000, Serbia
Special Hospital for Cerebrovascular Diseases "Sveti Sava"
Belgrade, 11000, Serbia
Clinical Center Kragujevac, Center for Radiology Diagnostic
Kragujevac, 34000, Serbia
Clinical Center Niš, Center of Radiology
Niš, 18000, Serbia
Clinical Center of Vojvodina, Center for Radiology
Novi Sad, 21000, Serbia
Neurology Clinic Hospital with Policlinic of F.D. Roosevelt
Banská Bystrica, 97517, Slovakia
I. Neurology Clinic, University Hospital Bratislava
Bratislava, 813 69, Slovakia
Radiology Clinic, University Hospital Martin
Martin, 03659, Slovakia
Neurology Clinic, Faculty Hospital Nitra
Nitra, 95001, Slovakia
Neurology Clinic, Central Military Faculty Hospital
Ružomberok, 036 26, Slovakia
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, 08916, Spain
Hospital General Vall d'Hebron, Barcelona
Barcelona, 08035, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Henry Li, PhD
- Organization
- Grifols Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Jeffrey Saver, MD
University of California, Los Angeles
- STUDY DIRECTOR
Peter Mitchell, MD
Melbourne Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2009
First Posted
November 17, 2009
Study Start
November 1, 2009
Primary Completion
November 1, 2013
Study Completion
February 1, 2014
Last Updated
October 21, 2015
Results First Posted
October 21, 2015
Record last verified: 2015-09