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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01014975




Registration number
NCT01014975
Ethics application status
Date submitted
16/11/2009
Date registered
17/11/2009
Date last updated
21/10/2015

Titles & IDs
Public title
A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
Scientific title
A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke
Secondary ID [1] 0 0
2010-019760-36
Secondary ID [2] 0 0
T05018-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Plasmin (Human)
Treatment: Other - Plasmin (Human)
Treatment: Other - Plasmin (Human)

Experimental: 20 mg Plasmin (Human) - 20 mg of Plasmin (Human)

Experimental: 40 mg Plasmin (Human) - 40 mg of Plasmin (Human)

Experimental: 80 mg Plasmin (Human) - 80 mg of Plasmin (Human)


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

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

Treatment: Other: Plasmin (Human)
Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort
Timepoint [1] 0 0
90 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Heidelberg Repatriation Hospital, Melbourne - Heidelberg
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Upper Austria
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
France
State/province [3] 0 0
Clermont-Ferrand
Country [4] 0 0
France
State/province [4] 0 0
Montpellier
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
France
State/province [6] 0 0
Toulouse
Country [7] 0 0
Serbia
State/province [7] 0 0
Belgrade
Country [8] 0 0
Serbia
State/province [8] 0 0
Kragujevac
Country [9] 0 0
Serbia
State/province [9] 0 0
Niš
Country [10] 0 0
Serbia
State/province [10] 0 0
Novi Sad
Country [11] 0 0
Slovakia
State/province [11] 0 0
Banská Bystrica
Country [12] 0 0
Slovakia
State/province [12] 0 0
Bratislava
Country [13] 0 0
Slovakia
State/province [13] 0 0
Martin
Country [14] 0 0
Slovakia
State/province [14] 0 0
Nitra
Country [15] 0 0
Slovakia
State/province [15] 0 0
Ružomberok
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Badalona
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Grifols Therapeutics LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01014975
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffrey Saver, MD
Address 0 0
University of California, Los Angeles
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01014975