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    Summary
    EudraCT Number:2007-007643-27
    Sponsor's Protocol Code Number:V10153-2S-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-02-01
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2007-007643-27
    A.3Full title of the trial
    A Phase IIa, Multi-Centre Study to Evaluate the Safety and Efficacy of V10153 in Acute Ischaemic Stroke
    A.3.2Name or abbreviated title of the trial where available
    VASTT
    A.4.1Sponsor's protocol code numberV10153-2S-01
    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 SponsorVernalis (R & D) Limited
    B.1.3.4CountryUnited Kingdom
    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 nameV10153
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 931101-84-7
    D.3.9.2Current sponsor codeV10153
    D.3.9.3Other descriptive nameRecombinant thrombin-activatable plasminogen
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 to mg/mL
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant, genetically engineered variant of human plasminogen
    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 Ischaemic Stroke
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the safety of five dose levels (1.0, 2.5, 5.0, 7.5 and 10.0 mg/kg) of V10153 in patients with acute ischaemic stroke.
    E.2.2Secondary objectives of the trial
    To compare recanalisation rates across dose levels.
    To compare clinical outcome between treatments by National Institue of Health Stroke Survey (NIHSS) at 24 hours, 5, 30 and 90 days and Modfied Rankin Score and Barthel Index at 5, 30 and 90 days.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Onset of new neurological signs of a stroke within 3 to 9 hours of the time to initiation of treatment with V10153.
    2. Be aged 18 and over.
    3. Provide written informed consent or appropriate surrogate consent and agree to comply with all protocol-specific procedures. (After it has been determined that a patient meets all of the clinical and CT scan inclusion criteria and none of the exclusion criteria, and after the study has been explained to the patient or the patient’s legal representative, he/she will be asked to sign a consent form prior to angiography, (unless angiography is standard of care)).
    4. Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive.
    5. Have a NIHSS score > 5 - at least 20.
    6. Patients with angiographic complete occlusion (TIMI 0) or penetration with minimal perfusion (TIMI 1) in any part of the middle cerebral artery (MCA), with that occlusion being consistent with the patient’s clinical presentation, (see Section 6.2.3 for TIMI definitions). Patients with tandem occlusions (carotid occlusion at bifurcation with thrombus in MCA) may also be enrolled.
    E.4Principal exclusion criteria
    Central Nervous System
    1. Coma.
    2. Stroke with unknown time of onset (unless last known to be well within the 9 hour window).
    3. Minor symptoms and signs (< 6 points on the NIHSS) which are rapidly improving by the time of enrolment.
    4. Major stroke symptoms and signs (> 20 on the NIHSS).
    5. Basilar artery territory strokes.
    6. Suspected lacunar or white matter stroke.
    7. Any history of stroke (haemorrhagic, embolic, thrombotic or transient ischaemic attack) within the previous 6 weeks.
    8. Any prior neurological event which would obscure the interpretation of the signal neurological deficits.
    9. Any history of brain tumours (small incidental meningioma are permitted).
    10. CT scan results in an ASPECT score of < 5, severe hypodensity lesion, haemorrhage of any degree, evidence of significant mass effect with midline shift due to large infarct, or subarachnoid haemorrhage.
    11. CT angiogram shows no visible arterial occlusion in any part of the MCA.
    12. Patients with van Sweiten Grade 4 (severe white matter disease).

    Haemorrhagic Risk
    1. Clinical presentation suggestive of subarachnoid haemorrhage, even if the initial CT scan is normal.
    2. Previous known intracranial haemorrhage at any time, and/or subarachnoid haemorrhage. Patients with a known arteriovenous malformation or aneurysm with any evidence of associated haemorrhage.
    3. Any recent invasive procedure (e.g. puncture of a non-compressible vessel (artery or vein) within 7 days of drug administration; surgery including ophthalmologic surgery, biopsy of a parenchymal organ, or lumbar puncture within 30 days of drug administration).
    4. Trauma, including head trauma, with internal injuries or ulcerative wounds within 90 days of drug administration.
    5. Active peptic ulcer disease within the 3 months prior to drug administration.
    6. Any clinically significant active or recent haemorrhage within 30 days of drug administration.
    7. Known hereditary or acquired haemorrhagic diathesis, e.g. activated Partial Thromboplastin Time (aPTT) greater than 1.5 times normal.
    8. Treatment with heparin within 12 hours prior to drug administration other than a small amount for flushing intravenous cannulae.
    9. Treatment with warfarin (unless the International Normalised Ratio (INR) is 1.5 or less) within 5 days prior to drug administration.
    10. Treatment with low molecular weight heparin within 5 days prior to study drug administration.
    11. Treatment with antiplatelet agents (dipyridamole, Aggrenox, ticlopidine) within 6 days prior to study drug administration with the exception of either aspirin (325 mgs or less daily) or clopidogrel (75 mgs, or less, daily) which are allowed, (but not both).

    Laboratory
    1. Baseline laboratory values which reveal platelets < 100,000/mm3, Haematocrit (Hct) or Packed Cell Volume (PCV) < 25 % or INR > 1.5.
    2. If creatinine is known, exclude for serum creatinine > 2.5 times the upper limit of normal (ULN).
    3. Haemoglobin < 10 g/dL = 100 g/L.
    4. Haematocrit (Hct) or PCV < 25 %.

    General
    1. Positive urine pregnancy test, breast feeding or parturition within the previous 30 days.
    2. Weight >135kg.
    3.Uncontrolled hypertension at study entry, non-responsive to acute intravenous therapy. Uncontrolled hypertension is defined as mean systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg on three repeated measures at least 5 minutes apart.
    4. Blood glucose > 12.0 mmol/L.
    5. Known serious sensitivity to contrast agents, or any condition in which CT angiography is contraindicated.
    6. Myocardial infarction within 30 days prior to study drug administration.
    7. Presumed septic embolus.
    8. History of or current serious illness e.g., known chronic renal disease or renal insufficiency, known active inflammatory bowel disease, ulcerative colitis, or diverticular disease, active or recent alcohol or substance abuse, cancer, Human Immunodeficiency Virus (HIV), significant hepatic, pulmonary, endocrine, neurological, haematological disease or any other condition which the investigator considers would increase the risk to the patient or reduce the validity of the study.
    9. Traumatic or prolonged cardiopulmonary resuscitation within 2 weeks prior to drug administration.
    10. Patients participating in another clinical trial evaluating an investigational study drug or device within 4 weeks prior to drug administration.
    11. Patients unwilling to participate or patients or their legal representative unable or unwilling to give informed consent.
    12. Patients or their legal representatives who are unable to provide an adequate medical history, onset time of stroke and a complete list of concomitant medication.
    13. Known prior exposure to aprotinin.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety:
    Safety determined through clinical assessment (intercranial haemorrhage (ICH), major systemic bleed, other serious adverse events (SAEs)).

    Adverse Events.

    Laboratory Variables.

    Vital Signs.

    ECG.

    Primary Efficacy:
    Recanalisation rates from a blinded assessment of CT Angiograms at 0 and 2 hours will be compared between dose levels.

    Secondary Efficacy:
    Clinical Outcome according to NIHSS at 24 hours, 5, 30 and 90 days, Modified Rankin Scale and Barthel Index at 5 days, 30 days and 90 days after treatment.
    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 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 concerned2
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.5.1Number of sites anticipated in the EEA14
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 No
    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
    Acute Ischaemic Stroke surrogate consent if unable to consent personally
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 80
    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 Decision2008-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-08-28
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