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    Summary
    EudraCT Number:2011-005317-37
    Sponsor's Protocol Code Number:THR-2010-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-01-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-005317-37
    A.3Full title of the trial
    Double blind, placebo controlled, escalating single-dose, pilot study to assess the safety of THR-18 when administered to patients suffering acute ischemic stroke and treated with tPA
    Estudio piloto a doble ciego, controlado con placebo, con escalado de dosis única, para evaluar la seguridad de THR-18 cuando se administra a pacientes que sufren un ictus isquémico agudo y tratados con tPA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Double blind, placebo controlled, escalating single-dose, pilot study to assess the safety of THR-18 when administered to patients suffering acute ischemic stroke and treated with tPA
    Estudio piloto a doble ciego, controlado con placebo, con escalado de dosis única, para evaluar la seguridad de THR-18 cuando se administra a pacientes que sufren un ictus isquémico agudo y tratados con tPA
    A.4.1Sponsor's protocol code numberTHR-2010-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01253512
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThrombotech Ltd.
    B.1.3.4CountryIsrael
    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 supportThrombotech Technologies Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThrombotech Technologies Ltd.
    B.5.2Functional name of contact pointArnon Aharon
    B.5.3 Address:
    B.5.3.1Street Address5 Golda Meir St.
    B.5.3.2Town/ cityNess Ziona
    B.5.3.3Post code74036
    B.5.3.4CountryIsrael
    B.5.4Telephone number97208-9102920
    B.5.5Fax number97208-9102867
    B.5.6E-mailarnon@thrombotech.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.3.2Product code THR-18
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTHR-18
    D.3.9.3Other descriptive name18 mer peptide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.25 to 0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute isquemic stroke
    Ictus isquémico agudo
    E.1.1.1Medical condition in easily understood language
    Acute isquemic stroke
    Ictus isquémico agudo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    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
    Assess the safety of intravenous administration of two escalating doses (0.25 and 0.5 mg/kg, 150 ml) of THR-18 or placebo, infused as a 10% bolus over 2 minutes (15 ml) followed by a 60 min infusion of the remaining dose (135 ml), to acute ischemic stroke patients treated with tPA.
    Evaluar la seguridad de la administración intravenosa de dos dosis crecientes (0,25 y 0,5 mg / kg, 150 ml) de THR-18 o placebo, infusión en bolo de 10% durante 2 minutos
    (15 ml) seguido de una infusión de 60 minutos de la dosis restante (135 ml), en pacientes con ictus isquémico agudo tratados con tPA.
    E.2.2Secondary objectives of the trial
    Assess the feasibility of evaluation of the efficacy parameters following intravenous administration of two escalating doses (0.25 and 0.5 mg/kg, 150 ml) of THR-18 or placebo, infused as a 10% bolus over 2 minutes (15 ml) followed by a 60 min infusion of the remaining dose (135 ml), to acute ischemic stroke patients treated with tPA.
    Evaluar la viabilidad de la evaluación de los parámetros de eficacia tras la administración por vía intravenosa de dos dosis crecientes (0,25 y 0,5 mg / kg, 150 ml) de THR-18 o placebo, infusión en bolo de 10% durante 2 minutos (15 ml), seguido de una infusión de 60 minutos de la dosis restante (135 ml), a pacientes con ictus agudo isquémico tratados con tPA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female.
    2) Diagnosis of acute ischemic stroke onset less than 3 hours prior to the planned start of intravenous tPA (alteplase).
    3) Have suffered an acute hemispheric ischemic stroke, defined as acute, focal, neurological deficit(s), secondary to a presumed vascular event, which must include at least one of the following:
    ? At least one of the following components (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11):
    o Language dysfunction (aphasic disorder, excluding dysarthria)
    o Visual field defect (excluding monocular blindness)
    o Extinction and Inattention (formerly Neglect)
    ? An indication on routine diffusion-weighted magnetic resonance imaging (DW-MRI) or computed tomography perfusion scan at screening /baseline that the acute stroke involves the cerebral cortex
    4) NIHSS larger > 5 and < 18 for left and right hemisphere strokes.
    5) Age 18-85 years both inclusive.
    6)Signed informed consent from patient or legally authorized representative or an independent witness or an independent physician, if applicable according to the Details about the consent procedure described in country-specific supplements to this protocol.
    7) Subjects are indicated for the application of intravenous tPA (alteplase).
    1) Hombre o mujer
    2) Diagnóstico del inicio de accidente cerebrovascular isquémico agudo inicio menor de 3 horas antes del inicio planeado de tPA intravenoso (alteplasa)
    3) Haber tenido un ictus isquémico agudo hemisférico, definido como agudo, con déficit focal y neurológico,
    secundaria a un evento vascular supone, que debe incluir al menos uno de los siguiente: Al menos uno de los siguientes componentes (como se refleja por lo menos 1 punto
    en cualquiera de los puntos correspondientes de la NIHSS: 9, 3 o 11): Lenguaje o disfunción (trastorno afásico, con exclusión de disartria) o defectos del campo visual (con exclusión de
    ceguera monocular) o de extinción y falta de atención (antes negligencia) - Indicación de RMN o TAC en el screening, de que ictus incluye la corteza cerebral
    4) NIHSS mayores> 5 y <de 18 para ictus del hemisferio izquierdo y derecho.
    5) Edad 18-85 años, ambos inclusive.
    6) Consentimiento informado del paciente o del representant legalmente autorizado o un testigo independiente o un médico independiente, según sea aplicable según los etalles del procedimiento de consentimiento decrito en los anexos a este proocolo específicos por país.
    7) Pacientes indicados ara la aplicación de tPA intravenoso (alteplasa)
    E.4Principal exclusion criteria
    2) Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence.
    3) Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage.
    7) Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2).
    8) High clinical suspicion of septic embolus.
    9) Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
    10) Baseline NIHSS greater than 18 for left and right hemisphere stroke.
    11) Evidence of acute or chronic ICH by head CT or MRI.
    14) Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control.
    15) Blood glucose greater than 200 mg/dl.
    18) Have suffered a stroke within 90 days of the screening/baseline assessments that is either diagnostically confirmed or assumed to be in the same cerebral territory as is the current acute stroke.
    32) Subjects with disabling congestive heart failure (CHF) or unstable angina.
    34) Subjects that suffered a myocardial infarction in the last 90 days.
    47) Have a positive urine pregnancy test at screening/baseline or be a lactating female.
    48) Any condition that in the investigator?s judgement precludes participation in the study.
    2) Intervalo de tiempo desde el inicio del ictus menor de 3 horas es imposible determinar con alto grado de confianza.
    3) Los síntomas que sugieren hemorragia subaracnoidea, aunque el TAC o la RMN sea negativo para la hemorragia.
    7) Déficit neurológico que ha llevado a estupor o coma (nivel de conciencia en la puntuación NIHSS mayor
    o igual a 2.
    8) Alta sospecha clínica de embolismo séptico.
    9) Ictus menor con déficit no invalidante o mejora rápida de síntomas neurológicos.
    10) NIHSS basal superior a 18 por ictus en el hemisferio izquierdo y derecho.
    11) Evidencia de hemorragia intracraneal en TAC o RMN
    14) Hipertensión persistente con presión sistólica mayor de 185 mmHg o diastólica superior a BP 110 mmHg (Media de tres lecturas consecutivas con brazo- manguito durante 20-30 minutos), no controlada por tratamiento antihipertensivo o que requieran nitroprusiato para el control
    15) Glucosa en sangre superior a 200 mg/dl.
    18) Haber sufrido un ictus dentro de los 90 días de la
    selección / evaluación basal que sea un diagnóstico confirmado o supuesto en el mismo territorio cerebral que el ictus actual
    32) Pacientes con insuficiencia cardíaca congestiva (ICC) discapacitante o angina inestable.
    34) Pacientes con infarto de miocardio en los últimos 90 días.
    47) Tener una prueba de embarazo positiva en orina en la selección o ser una mujer lactante.
    48) Cualquier otra condición que a juicio del investigador impida la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study variables will include the evaluation of the safety and elucidation of the PK profile of THR-18 in ischemic stroke subjects treated with tPA.
    Las variables principales del estudio incluirá la evaluación de la seguridad y el aclaramiento del perfil de farmacocinética de THR-18 en pacientes con ictus tratados con tPA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - The general safety assessments (physical examination, vital signs, clinical laboratory analyses and 12-lead ECGs) during the study will be compared descriptively between subjects.

    - Clinical laboratory test results

    - Occurrence of adverse events.
    - Pharmacokinetic study variables:

    Concentration-time data
    Las evaluaciones de seguridad general (examen físico, signos vitales, análisis de laboratorio clínico y electrocardiogramas de 12 derivaciones) durante el estudio se compararán de forma descriptiva entre los sujetos.
    - Pruebas de laboratorio clínico
    - Aparición de eventos adversos
    ? Variables de estudio de farmacocinética: datos de concentración-tiempo
    E.5.2Secondary end point(s)
    The secondary study variables include evaluation of the feasibility to use the efficacy parameters to detect an initial signal of efficacy.
    Las variables secundarias de estudio incluyen la evaluación de la factibilidad de utilizar los parámetros de eficacia para detectar una señal inicial de eficacia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Rate of improvement in imaging parameters from baseline to day 3 in infarct and edema size using MRI

    2) Number of subjects achieving good neurological outcome as assessed by NIHSS and mRS scores

    3) Number of subjects achieving good neurological outcome as assessed by NIHSS and mRS scores
    1)La tasa de mejoría en los parámetros de imagen desde el inicio hasta el día 3 del ictus y el tamaño del edema mediante RMN
    2)Número de individuos que alcanzaron un buen resultado neurológico según la evaluación de las puntuaciones NIHSS y mRS 3)Número de paciente que alcanzaron buenos resultados neurológicos según la evaluación de resultados de la NIHSS y la mRS
    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 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) 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    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
    India
    Israel
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with acute ischemic stroke
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 22
    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)
    No
    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 Decision2012-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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