Acute Ischemic StrokePhase 1/2NCT01014975
A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
A Phase 1/2 study testing Plasmin (Human) in people with Acute Ischemic Stroke, run by Grifols Therapeutics LLC at 23 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Plasmin (Human)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 23 sitesin 6 countries
- Study dates
- Nov 2009to Feb 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
Serbia5 sites
Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery
Belgrade, 11000
Special Hospital for Cerebrovascular Diseases "Sveti Sava"
Belgrade, 11000
Clinical Center Kragujevac, Center for Radiology Diagnostic
Kragujevac, 34000
Clinical Center Niš, Center of Radiology
Niš, 18000
Clinical Center of Vojvodina, Center for Radiology
Novi Sad, 21000
Slovakia5 sites
Neurology Clinic Hospital with Policlinic of F.D. Roosevelt
Banská Bystrica, 97517
I. Neurology Clinic, University Hospital Bratislava
Bratislava, 813 69
Radiology Clinic, University Hospital Martin
Martin, 03659
Neurology Clinic, Faculty Hospital Nitra
Nitra, 95001
Neurology Clinic, Central Military Faculty Hospital
Ružomberok, 036 26
Spain5 sites
Hospital Universitario Germans Trias i Pujol
Badalona, 08916
Hospital General Vall d'Hebron, Barcelona
Barcelona, 08035
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
France4 sites
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
Hôpital Gui de Chauliac
Montpellier, 34295
Hôpital Bichat-Claude Bernard
Paris, 75877
Hôpital Rangueil
Toulouse, 31059
Australia2 sites
Heidelberg Repatriation Hospital, Melbourne
Heidelberg, Victoria, 3084
Royal Melbourne Hospital
Parkville, Victoria, 3050
Austria2 sites
O.O. Landes-Nervenklinik Wagner-Jauregg
Linz, Upper Austria, 4020
Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie
Salzburg, State of Salzburg, 5020
About this study
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
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.
Read the 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
- Being tested
- Plasmin (Human)
- Keywords
- stroke, plasmin, thrombus, ischemic, middle cerebral artery, thrombolysis, intra-arterial, fibrin
- Medical subject headings
- Ischemic Stroke, Stroke, Thrombosis, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmin (Human)Biological
Also called TAL-05-00018, BAY-57-9602
Plasmin (Human), 20 mg, delivered through a catheter into a thrombus
Plasmin (Human)Biological
Also called TAL-05-00018, BAY-57-9602
Plasmin (Human), 40 mg, delivered through a catheter into a thrombus
Plasmin (Human)Biological
Also called TAL-05-00018, BAY-57-9602
Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
| Study group | Role | What they receive |
|---|---|---|
| 20 mg Plasmin (Human) | Experimental | 20 mg of Plasmin (Human) Receives: Biological: Plasmin (Human) |
| 40 mg Plasmin (Human) | Experimental | 40 mg of Plasmin (Human) Receives: Biological: Plasmin (Human) |
| 80 mg Plasmin (Human) | Experimental | 80 mg of Plasmin (Human) Receives: Biological: Plasmin (Human) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Saver, MD, Study director, University of California, Los AngelesPeter Mitchell, MD, Study director, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014975
- Sponsor's protocol ID
- T05018-1001
- Other IDs
- 2010-019760-36
- Status last verified
- Sep 2015
- First submitted
- 16 Nov 2009
- Last updated
- 21 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01014975
- Acronym / sponsor ID
- T05018-1001
- Conditions
- Acute Ischemic Stroke
- Keywords
- stroke, plasmin, thrombus, ischemic, middle cerebral artery, thrombolysis, intra-arterial, fibrin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Posted 21 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 mg Plasmin (Human) | Experimental | Biological: Plasmin (Human)20 mg of Plasmin (Human) |
| 40 mg Plasmin (Human) | Experimental | Biological: Plasmin (Human)40 mg of Plasmin (Human) |
| 80 mg Plasmin (Human) | Experimental | Biological: Plasmin (Human)80 mg of Plasmin (Human) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmin (Human)Also: TAL-05-00018, BAY-57-9602Plasmin (Human), 20 mg, delivered through a catheter into a thrombus | Biological | 20 mg Plasmin (Human) |
| Plasmin (Human)Also: TAL-05-00018, BAY-57-9602Plasmin (Human), 40 mg, delivered through a catheter into a thrombus | Biological | 40 mg Plasmin (Human) |
| Plasmin (Human)Also: TAL-05-00018, BAY-57-9602Plasmin (Human), 80 mg, delivered through a catheter into a thrombus | Biological | 80 mg Plasmin (Human) |
Primary outcome
Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Saver, MD study director
University of California, Los Angeles
Peter Mitchell, MD study director
Melbourne Health
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Plasmin (Human) in people with Acute Ischemic Stroke, run by Grifols Therapeutics LLC at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Serbia, Slovakia, Spain, France, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.