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    Summary
    EudraCT Number:2005-001075-35
    Sponsor's Protocol Code Number:TG-M-003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-08-29
    Trial results View results
    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 - BfArM
    A.2EudraCT number2005-001075-35
    A.3Full title of the trial
    AN OPEN-LABEL CLINICAL TRIAL OF INTRA-ARTERIAL MICROPLASMIN ADMINISTRATION IN PATIENTS WITH ACUTE INTRACRANIAL VERTEBROBASILAR ARTERY OCCLUSION
    A.3.2Name or abbreviated title of the trial where available
    MITI-IA
    A.4.1Sponsor's protocol code numberTG-M-003
    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 SponsorThromboGenics Ltd.
    B.1.3.4CountryIreland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameMicroplasmin
    D.3.2Product code M-PLA-P10/40
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNMicroplasmin
    D.3.9.2Current sponsor codeM-PLA-P10/40
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 No
    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
    ACUTE INTRACRANIAL VERTEBROBASILAR ARTERY OCCLUSION RESULTING IN ACUTE ISCHEMIC STROKE
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10048963
    E.1.2Term Basilar artery occlusion
    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 and the arterial recanalization potential of microplasmin when administered intra-arterially in patients with acute intracranial vertebrobasilar artery occlusion
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. New neurologic signs in the vertebrobasilar artery distribution allowing initiation of study drug treatment within 24 hours of the onset of neurological symptoms (loss of consciousness, dysarthria, anarthria, hemianopia, tetraparesis, tetraplegia, bilateral Babinski sign, dysphagia, double vision, nystagmus); other non-specific neurological symptoms such as dizziness, headache, vomiting, nausea are not restricted to the 24 hour time window
    2. Patients with angiographically documented vertebrobasilar artery occlusion
    3. Age 18-75 (inclusive).
    4. Women of child-bearing potential must have a negative pregnancy test prior to enrolment and be using a reliable form of contraception
    5. For conscious patients, prior to inclusion in the study and following a full explanation of the nature and purpose of the study, the patient or the patient’s legal representative must consent/assent to participate by signing the Informed Consent document. For unconscious patients or patients whose legal representative cannot be contacted or where it is not possible to obtain consent in advance of enrolment in the study, consent must be obtained as soon as possible after inclusion.
    E.4Principal exclusion criteria
    1. Patients with coma >6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation
    2. Rapidly improving neurologic signs at any time before initiation of study drug administration.
    3. Known contrast agent-sensitivity
    4. Uncontrolled hypertension defined as a systolic blood pressure > 180 mm Hg or a diastolic blood pressure > 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.
    5. History of stroke within the previous 6 weeks.
    6. Seizures at any time between stroke onset to planned initiation of study drug.
    7. History of intracranial hemorrhage
    8. History of surgery, lumbar puncture, biopsy or trauma to internal organs within the previous 30 days.
    9. Head trauma within the previous 90 days.
    10. Known bleeding diathesis.
    11. Baseline INR >1.7 or baseline APTT > 2 times normal
    12. Baseline platelet count < 100 X 109/L.
    13. Hypodensity on CT or diffusion abnormality on MRI of greater than half the brain stem
    14. Blood glucose > 400mg/dl
    15. Patients who have received intra-arterial or systemic thrombolytic therapy within the 7 days prior to the study.
    16. Patients who have received tPA or any other thrombolytic agent for the qualifying stroke.
    17. Patients receiving vitamin-K antagonists or heparin which results in either an INR>1.4 or an aPTT>2 times control (ULN for the hospital laboratory), respectively.
    18. Patients who have received glycoprotein IIb/IIIa inhibitors within 48 hours prior to enrolment.
    19. Patients who have received more than one dose of low molecular weight heparin within 48 hours prior to enrolment.
    20. Participation in another study with an investigational drug or device within the previous 30 days, prior participation in the present study, or planned participation in another trial within the timeframe of the current trial
    21. Life expectancy <3 months
    22. Other serious illness that in the opinion of the investigator may confound clinical assessment (eg hepatic, cardiac, or renal failure, advanced cancer)
    E.5 End points
    E.5.1Primary end point(s)
    STUDY ENDPOINTS

    SAFETY EVALUATIONS/CRITERIA

    The safety profile of a single dose regimen of microplasmin administered intra-arterially in patients with acute intracranial vertebrobasilar stroke will be defined based on the rate of occurrence of:

    Safety parameters:
    · Intracranial hemorrhage,
    · Major bleeding *,
    · Bleeding other than major,
    · Reocclusion at 48 hr after initiation of study drug (as determined by CT angiography),
    · Serious and non-serious adverse events,
    · Allergic reactions,
    · Immunology (Microplasmin and Staphylokinase antibody assays)
    · Laboratory data
    · Markers of systemic lysis (fibrinogen, plasminogen, D-dimer, PT and aPTT) and complement activation C3, C4 and CH50)

    * In the context of this study major bleeding is defined as any bleeding event resulting in death; any retroperitoneal hemorrhage; overt bleeding associated with a need for transfusion of 2 or more units of blood or which requires surgical intervention; overt bleeding associated with a decrease from baseline in hemoglobin of at least 2.0 g/dL.

    EFFICACY EVALUATIONS/CRITERIA

    Primary efficacy endpoint
    · Proportion of patients achieving recanalization of the basilar artery (defined as an improvement of at least one TIMI grade*) at the end of study drug administration
    * TIMI 0: no reperfusion
    TIMI 1: reperfusion without distal branch filling
    TIMI 2: reperfusion with incomplete or slow distal branch filling
    TIMI 3: full perfusion

    Secondary efficacy endpoints
    · Duration of study drug administration to achieve recanalization
    . Proportion of patient achieving TIMI 3 and TIMI 2 or 3 grade at the end of study drug administration
    · Survival at day 90
    · NIHSS total score at 90 days (or last rating) adjusted for baseline NIHSS total score
    . Proportion of patients who achieve an NIHSS total score at 90 days (or last rating) of 1 or less or who show an improvement from baseline in NIHSS total score of at least 8 points or more.
    · Change from baseline in NIHSS at day 7
    · Barthel Index and Modified Rankin scale at day 90

    ADDITIONAL EVALUATIONS

    · Markers of systemic lysis (fibrinogen, plasminogen, D-dimer, PT and aPTT) and complement activation (C3, C4 and CH50)
    · Pharmacokinetic measurements.
    · Pharmacodynamic measurements (α2-antiplasmin)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The end of the trial is defined as the last visit of the last subject, unless the Safety Committee recommends premature termination of the trial as a result of safety concerns.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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
    Due to the nature of the indication and the severity of this type of stroke, patients may not be able to give their informed consent to participate. In that case the principle of presumed consent will apply. (See incl. criteria for explanation.)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Standard care
    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 Decision2006-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-09-16
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