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

Primary Purpose

Acute Ischemic Stroke

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Plasmin (Human)

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring stroke, plasmin, thrombus, ischemic, middle cerebral artery, thrombolysis, intra-arterial, fibrin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Heidelberg Repatriation Hospital, Melbourne
Royal Melbourne Hospital
O.O. Landes-Nervenklinik Wagner-Jauregg
Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie
Hôpital Gabriel Montpied
Hôpital Gui de Chauliac
Hôpital Bichat-Claude Bernard
Hôpital Rangueil
Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery
Special Hospital for Cerebrovascular Diseases "Sveti Sava"
Clinical Center Kragujevac, Center for Radiology Diagnostic
Clinical Center Niš, Center of Radiology
Clinical Center of Vojvodina, Center for Radiology
Neurology Clinic Hospital with Policlinic of F.D. Roosevelt
I. Neurology Clinic, University Hospital Bratislava
Radiology Clinic, University Hospital Martin
Neurology Clinic, Faculty Hospital Nitra
Neurology Clinic, Central Military Faculty Hospital
Hospital Universitario de Bellvitge
Hospital Universitario Germans Trias i Pujol
Hospital General Vall d'Hebron, Barcelona
Hospital General Universitario Gregorio Marañon
Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

20 mg Plasmin (Human)

40 mg Plasmin (Human)

80 mg Plasmin (Human)

Arm Description

20 mg of Plasmin (Human)

40 mg of Plasmin (Human)

80 mg of Plasmin (Human)

Outcomes

Primary Outcome Measures

Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort

Secondary Outcome Measures

Full Information

NCT ID

NCT01014975

First Posted

November 16, 2009

Last Updated

September 22, 2015

Sponsor

Grifols Therapeutics LLC

1. Study Identification

Unique Protocol Identification Number

NCT01014975

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Grifols Therapeutics LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

stroke, plasmin, thrombus, ischemic, middle cerebral artery, thrombolysis, intra-arterial, fibrin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

20 mg Plasmin (Human)

Arm Type

Experimental

Arm Description

20 mg of Plasmin (Human)

Arm Title

40 mg Plasmin (Human)

Arm Type

Experimental

Arm Description

40 mg of Plasmin (Human)

Arm Title

80 mg Plasmin (Human)

Arm Type

Experimental

Arm Description

80 mg of Plasmin (Human)

Intervention Type

Biological

Intervention Name(s)

Plasmin (Human)

Other Intervention Name(s)

TAL-05-00018, BAY-57-9602

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Plasmin (Human)

Other Intervention Name(s)

TAL-05-00018, BAY-57-9602

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Plasmin (Human)

Other Intervention Name(s)

TAL-05-00018, BAY-57-9602

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Saver, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Peter Mitchell, MD

Organizational Affiliation

Melbourne Health

Official's Role

Study Director

Facility Information:

Facility Name

Heidelberg Repatriation Hospital, Melbourne

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

O.O. Landes-Nervenklinik Wagner-Jauregg

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4020

Country

Austria

Facility Name

Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Hôpital Gabriel Montpied

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

Hôpital Gui de Chauliac

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Hôpital Bichat-Claude Bernard

City

Paris

ZIP/Postal Code

75877

Country

France

Facility Name

Hôpital Rangueil

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Special Hospital for Cerebrovascular Diseases "Sveti Sava"

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Center Kragujevac, Center for Radiology Diagnostic

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Clinical Center Niš, Center of Radiology

City

Niš

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Clinical Center of Vojvodina, Center for Radiology

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Neurology Clinic Hospital with Policlinic of F.D. Roosevelt

City

Banská Bystrica

ZIP/Postal Code

97517

Country

Slovakia

Facility Name

I. Neurology Clinic, University Hospital Bratislava

City

Bratislava

ZIP/Postal Code

813 69

Country

Slovakia

Facility Name

Radiology Clinic, University Hospital Martin

City

Martin

ZIP/Postal Code

03659

Country

Slovakia

Facility Name

Neurology Clinic, Faculty Hospital Nitra

City

Nitra

ZIP/Postal Code

95001

Country

Slovakia

Facility Name

Neurology Clinic, Central Military Faculty Hospital

City

Ružomberok

ZIP/Postal Code

036 26

Country

Slovakia

Facility Name

Hospital Universitario de Bellvitge

City

L´Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Universitario Germans Trias i Pujol

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital General Vall d'Hebron, Barcelona

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Universitario Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

12. IPD Sharing Statement

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

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