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    Summary
    EudraCT Number:2009-012086-66
    Sponsor's Protocol Code Number:T05018-1001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-02
    Trial results Removed from public view
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2009-012086-66
    A.3Full title of the trial
    A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke
    A.4.1Sponsor's protocol code numberT05018-1001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGrifols Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGrifols Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrifols Inc
    B.5.2Functional name of contact pointKecia Courtney
    B.5.3 Address:
    B.5.3.1Street Address79 TW Alexander Drive, Research Triangle Park
    B.5.3.2Town/ cityNorth Carolina
    B.5.3.3Post code27709
    B.5.3.4CountryUnited States
    B.5.6E-mailKecia.Courtney@grifols.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePlasmin (Human)
    D.3.2Product code TAL-05-00018
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Thrombus in acute ischemic stroke of the middle cerebral artery
    E.1.1.1Medical condition in easily understood language
    Stroke
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10008190
    E.1.2Term Cerebrovascular accident
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the safety of Plasmin (Human) in escalating doses in patients with acute MCA ischemic stroke given within 9 hours of stroke symptom onset.
    E.2.2Secondary objectives of the trial
    • To determine the proportion of Treatment Successes - the proportion of patients with treatment success defined as partial or full recanalization as designated by a score of 2a, 2b, or 3 on the Thrombosis In Cerebral Infarction (TICI) scale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 through 85 years of age, inclusive
    2. Male and female patients
    3. New focal, potentially disabling neurologic deficit clinically localized to the MCA distribution
    4. Catheter Arteriography - Complete occlusion or contrast penetration with minimal perfusion of either the M1 segment and/or M2 segment and/or M2 division of the MCA (M1, M2, or M1-2 only) as assessed by arteriography (Section 3.2.3.1)
    5. Intra-arterial (IA) therapy with Plasmin must be completed within 9 hours of stroke onset (e.g., Plasmin
    infusion must start: 1) within 8.5 hours of stroke onset in cohorts 1, 2a and 2b; 2) within 8 hours of stroke onset in cohort 2c; and 3) within 8 or 8.5 hours of stroke onset in cohort 3, depending on the infusion rate/time selected from cohort 2).
    6. An NIHSS score of ≥4 and ≤25, except for isolated aphasia
    7. Women of child-bearing potential must practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception,
    placement of an intrauterine device [IUD] or intrauterine system [IUS], condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study and must have a negative pregnancy test prior to study entry
    8. Willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the patient in accordance with local law and institutional policy
    E.4Principal exclusion criteria
    1. Patient is eligible for IV administration of tissue plasminogen activator (e.g. alteplase)
    2. Previous treatment for this event with mechanical embolectomy or cerebral angioplasty / stenting of target lesion
    3. Treatment with any PA (e.g., streptokinase (e.g., Streptase®, Kabikinase®), anistreplase (Eminase®), alteplase (e.g., Activase®), reteplase (e.g., Retavase®), tenecteplase (TNKase™), UK (Abbokinase)) within the last 48 hours
    4. Therapy with a Glycoprotein IIb/IIIa inhibitor (e.g. abciximab) in the 5 days prior to study enrollment or at any time during the study
    5. Clinical evidence of significant medical, neurologic, or psychiatric disease that may confound the study outcome assessments
    6. Women who are pregnant or lactating or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable or implanted
    hormonal methods of contraception, placement of an intrauterine device [IUD] or intrauterine system [IUS] condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout
    the study
    7. Participation in another treatment clinical study within 30 days prior to entry
    8. History of intracranial procedures or intracranial or systemic bleeding within the last year
    9. Previous history of intracranial neoplasm (except meningioma)
    10. History of stroke in previous 6 weeks
    11. Within 48 hours, major or minor surgery, biopsy of a parenchymal organ, or major trauma/injury with internal injuries, lumbar puncture or hemorrhage
    12. Catheter Arteriography - Inability for whatever reason (e.g. arterial stenosis, vessel tortuosity) to access the target lesion and achieve contact between the microcatheter and the proximal aspect of the target thrombus
    13. Acute ICH of any degree or location
    14. Evidence of active bleeding/ hemorrhage or acute trauma on physical examination
    15. Coma or severe obtundation with fixed eye deviation and complete hemiplegia. Coma is defined as 2 or more points in the NIHSS Level of Consciousness exam item.
    16. An NIHSS score > 25
    17. Significant intracranial mass effect leading to midline shift
    18. Acute hypodense/hyperintense parenchymal lesion or effacement of cerebral sulci in more than one third of the MCA distribution as confirmed during pre-study imaging
    19. Seizures at onset of stroke symptoms
    20. Uncontrolled hypertension defined by a systolic blood pressure > 180 mmHg or
    diastolic blood pressure > 110 mmHg on 3 separate occasions at least 10 minutes
    apart or requiring intravenous antihypertensive treatment by continuous infusion to
    reduce blood pressure to within these limits
    21. Known hereditary or acquired hemorrhagic diathesis with baseline international
    normalized ratio (INR) > 1.7, activated partial thromboplastin time (aPTT) > 1.5
    times normal, or baseline platelet count <100 x 109/L
    22. Presence of an unsecured aneurysm
    23. Clinical presentation suggestive of subarachnoid hemorrhage, even if initial imaging study is normal
    24. Suspected lacunar stroke
    25. Proximal stenosis with complete occlusion or simultaneous stenting / angioplasty, if deemed necessary by the interventionalist. Stenosis that does not impair accessibility to the primary lesion is allowed.
    26. Known or presumed septic embolus
    27. Creatinine ≥ 2.0 mg/dL or patient on renal dialysis
    28. Previous severe or anaphylactic or anaphylactoid reaction to contrast agent,
    streptokinase, or blood products
    E.5 End points
    E.5.1Primary end point(s)
    • To evaluate the safety of Plasmin (Human) in escalating doses in patients with acute MCA ischemic stroke given within 9 hours of stroke symptom onset
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/IIa
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    France
    Germany
    Israel
    Serbia
    Slovakia
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV is day 90 of the last patient enrolled in the final cohort
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients are in a emergency situtation they must be willing to provide written informed consent or have a legal representative able to provide written informed consent on behalf of the patient in accordance with local law and institutional policy
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 61
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    n/a
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-10
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