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    Summary
    EudraCT Number:2015-000105-39
    Sponsor's Protocol Code Number:PRL001-PB-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-15
    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 number2015-000105-39
    A.3Full title of the trial
    A PHASE 2B/3, MULTICENTER, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE COMBINATION OF CYCLOSPORINE AND OMEPRAZOLE AND OMEPRAZOLE ALONE IN PARTICIPANTS WITH NEW ONSET TYPE 1 DIABETES
    Estudio de Fase 2b/3, multicéntrico, aleatorizado, abierto para evaluar la combinación de ciclosporina y omeprazol frente a omeprazol sólo, en sujetos con Diabetes tipo 1 de reciente aparición.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Insulin Independence Trial
    A.3.2Name or abbreviated title of the trial where available
    IIT
    A.4.1Sponsor's protocol code numberPRL001-PB-01
    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 SponsorPerle Bioscience 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 supportPerle Bioscience Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyreon Corporation
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address260-1401 West 8th Avenue
    B.5.3.2Town/ cityVancouver
    B.5.3.3Post codeBC V6H 1C9
    B.5.3.4CountryCanada
    B.5.4Telephone number0016046765900
    B.5.5Fax number0016046765911
    B.5.6E-mailkarina.rodrigues@syreon.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 Yes
    D.2.1.1.1Trade name Omeprazole 20mg Gastro-resistant hard Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameOmeprazole
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmeprazole
    D.3.9.1CAS number 73590-58-6
    D.3.9.2Current sponsor codeOmeprazole
    D.3.9.3Other descriptive nameOMEPRAZOL
    D.3.9.4EV Substance CodeSUB09439MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Neoral Soft Gelatin Capsules 25mg Neciclopin 25mg Soft Gelatin Capsules & Neoral Soft Gelatin Capsules 100mg Neciclopin 100mg Soft Gelatin Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK Ltd (Trading as Sandoz Pharmaceuticals)
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCyclosporine
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.2Current sponsor codeCyclosporine
    D.3.9.3Other descriptive nameCyclosporina
    D.3.9.4EV Substance CodeSUB06250MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early onset type 1 diabetes mellitus
    Diabetes mellitus tipo 1 de reciente aparición
    E.1.1.1Medical condition in easily understood language
    Early onset diabetes mellitus type 1
    Diabetes mellitus tipo 1 de reciente aparicion
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10012609
    E.1.2Term Diabetes mellitus juvenile onset
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 compare the frequency of insulin independence in participants with new onset type 1 diabetes who are randomized to receive either combination therapy with cyclosporine and omeprazole, or omeprazole alone, for a period of 24 weeks.
    Comparar la frecuencia de la independencia de la insulina en participantes con diabetes de tipo 1, de aparición reciente, que han sido aleatorizados para recibir el tratamiento asociado con ciclosporina y omeprazol, u omeprazol solo, durante un período de 24 semanas.
    E.2.2Secondary objectives of the trial
    ? Evaluate safety and tolerability of combination therapy with cyclosporine and omeprazole.
    ? Compare the frequency of insulin independence of combination therapy with cyclosporine and omeprazole therapy versus no treatment (historical controls).
    ? Compare the frequency of insulin independence with omeprazole alone versus no treatment (historical controls).
    ? Assess pancreatic beta cell function.
    ? Assess blood glucose control.
    ? Assess average daily insulin requirement per week.
    ? Evaluate changes in immune markers.
    ? Evaluar la seguridad y la tolerabilidad del tratamiento asociado con ciclosporina y omeprazol.
    ? Comparar la frecuencia de la insulino-independencia del tratamiento asociado con ciclosporina y omeprazol, en comparación con la ausencia de tratamiento (grupo de referencia histórico).
    ? Comparar la frecuencia de la insulino-independencia del omeprazol solo en comparación con la ausencia de tratamiento (grupo de referencia histórico).
    ? Evaluar la función de las células beta del páncreas.
    ? Evaluar la determinación de la glucemia.
    ? Evaluar el uso diario de insulina a la semana.
    ? Evaluar los cambios en los marcadores inmunológicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female participant 10-20 years old.
    2. Diagnosis of new onset type 1 diabetes within 12 weeks of symptoms according to the American Diabetes Association (ADA) criteria.
    3. History of at least one positive result on testing for any of the following antibodies: Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2), Glutamic Acid Decarboxylase (GAD) autoantibodies, Insulin autoantibodies.
    4. Body weight > 30 kg at Screening (Day -14 and Extension).
    5. Day 0 within 12 weeks of the first visit to any physician for symptoms or signs of diabetes.
    6. Requires insulin > 0.2 units/kg body weight/day for T1DM between diagnosis and Day 0.
    7. Fasting C-peptide at Screening (Day -14 and Extension) greater than 0.3 ng/mL = 0.1 nmol/L = 100 pmol/L = 0.1 pmol/mL and Glucagon Stimulated C-peptide greater than 0.6 ng/mL = 0.2 nmol/L = 200 pmol/L = 0.2 pmol/mL.
    8. Female of child bearing potential must have a negative pregnancy test and practice acceptable contraception [e.g., oral, intramuscular, or implanted hormonal contraception, sexual partner with nonreversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intrauterine device] or surgically sterile (tubal ligation or hysterectomy at least 6 months prior to Day 0)]. Female of childbearing potential must undergo pregnancy testing within 24 hours prior to administration of the first dose of IMP.
    9. Able to swallow capsules.
    10. Able to read, understand, and provide signed informed consent for the study (participants under the age of 18, shall provide an assent for the study as per country requirements).
    1. Participantes hombres o mujeres, de 10 a 20 años de edad.
    2. Diagnóstico de diabetes de tipo 1, de aparición reciente, en un plazo de 12 semanas a partir de la aparición de los síntomas, conforme a los criterios de la Asociación Estadounidense de Diabetes (American Diabetes Association, ADA).
    3. Antecedentes de al menos un resultado positivo en las pruebas para cualquiera de los siguientes anticuerpos: autoanticuerpos contra las células de los islotes 512 (ICA512)/antígeno de islote-2 (IA-2), autoanticuerpos contra la descarboxilasa del ácido glutámico (Glutamic Acid Decarboxylase, GAD), autoanticuerpos contra la insulina.
    4. Peso corporal > 30 kg en la selección (día -14 y ampliación).
    5. El día 0, en un plazo de 12 semanas a partir de la primera visita a cualquier médico, por síntomas o signos de diabetes.
    6. Precisa tratamiento con insulina > 0,2 unidades de insulina/kg de peso corporal al día para la diabetes mellitus de tipo 1 entre el diagnóstico y el día 0.
    7. Péptido C en ayunas, en la selección, superior a 0,3 ng/ml = 0,1 nmol/l = 100 pmol/l = 0,1 pmol/ml, y péptido C estimulado por glucagón superior a 0,6 ng/ml = 0,2 nmol/l = 200 pmol/l = 0,2 pmol/ml.
    8. Las mujeres en edad fértil deben obtener un resultado negativo en la prueba de embarazo y deben utilizar métodos anticonceptivos aceptables (por ej., anticoncepción hormonal oral, intramuscular o implantada, pareja sexual con vasectomía no reversible [con azoospermia en dos pruebas], dos métodos de barrera [por ej., preservativo, diafragma o espermicida], o dispositivo intrauterino) o estéril de manera quirúrgica (ligadura de trompas o histerectomía al menos 6 meses antes de la inscripción). Las mujeres en edad fértil deben someterse a pruebas de embarazo en las 24 horas anteriores a la administración de la primera dosis del fármaco del estudio.
    9. Ser capaces de tragar cápsulas.
    10. Ser capaces de leer, comprender y proporcionar el consentimiento informado firmado para el estudio (los participantes menores de 18 años deben proporcionar el asentimiento para el estudio conforme a los requisitos del país).
    E.4Principal exclusion criteria
    1. Any medical condition that, in the opinion of the investigator, would interfere withsafe completion of the trial or impact participant safety or evaluability of drug effect.
    2. Prior administration of immunosuppressants at any time in the past, including in a clinical trial for type 1 diabetes.
    3. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks prior to Day 0.
    4. Taking any prescription medications, vitamins or herbal supplements that are contraindicated with cyclosporine within the last 14 days prior to Day 0.
    5. Pregnant or lactating female.
    6. Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion.
    7. Current treatment with oral antidiabetic agents.
    8. Evidence of active or latent tuberculosis.
    9. Vaccination with a live virus or organism within the last 8 weeks prior to Day 0.
    10. Influenza vaccination with a killed virus, including booster vaccinations, within the last 4 weeks prior to Day 0.
    11. Vaccination with other antigens or killed organisms within the last 8 weeks prior to Day 0.
    12. Any infectious mononucleosis-like illness within the last 6 months prior to Day 0.
    13. History of or known active infection with HIV, HCV, or HBV.
    14. Systolic or diastolic blood pressure >150 mmHg and > 90 mmHg, respectively, at Screening (Day -14 and Extension) as measured by an appropriately sized cuff.
    15. 95th percentile for weight at Screening (Day -14, Day -7, and Extension).
    16. An aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin level >2 times the upper limit of normal (ULN) at Screening (Day -7 and Extension).
    17. A blood urea nitrogen (BUN) > 50 mg/dL (> 17.85 mmol/L) or a serum creatinine level > 1.3 mg/dL (> 115 µmol/L) at Screening (Day -7 and Extension).
    18. A serum amylase level > 1.5 times the ULN or a serum lipase level > 2 times the ULN at Screening (Day -7 and Extension).
    19. A history of substance abuse or dependence within the last 12 months prior to Day 0 as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria.
    1. Cualquier afección médica que, en opinión del investigador, interferiría con la finalización de forma segura del ensayo clínico, o afectaría a la seguridad del participante o a la capacidad de evaluación del efecto del fármaco.
    2. Administración anterior de inmunosupresores en cualquier momento en el pasado, incluido en un ensayo clínico para la diabetes de tipo 1.
    3. Participación en cualquier tipo de ensayo clínico de fármacos o vacunas terapéuticas en las últimas 12 semanas antes del día 0 del estudio.
    4. Tomar cualquier medicamento con receta, vitaminas o suplementos herbarios que esté contraindicado con la ciclosporina 14 días antes del día 0.
    5. Mujeres embarazadas o en período de lactancia.
    6. Tratamiento actual con agonistas del receptor de GLP-1 (por ej., exenatida o pramlintida), o con cualquier otro fármaco que pueda estimular la regeneración de las células ? del páncreas o la secreción de insulina.
    7. Tratamiento actual con antidiabéticos orales.
    8. Indicio de tuberculosis activa o latente.
    9. Vacunación con un virus u organismo vivo dentro de las 8 semanas antes del día 0.
    10. Vacunación contra la gripe elaborada con un virus muerto, incluidas las vacunaciones de refuerzo, dentro de las 4 semanas antes del día 0.
    11. Vacunación con otros antígenos u organismos muertos dentro de las 8 semanas antes del día 0.
    12. Cualquier enfermedad infecciosa similar a la mononucleosis dentro de los 6 meses antes del día 0.
    13. Antecedentes de infección activa conocida por el VIH, VHC o VHB, o presencia de dicha infección.
    14. Tensión arterial sistólica o diastólica > 150 mmHg y > 90 mmHg, respectivamente, en la selección, medida con un esfigmomanómetro de tamaño adecuado. (día -14 y ampliación)
    15. Percentil del 95 para peso en la selección (día -14, día -7 y ampliación)
    16. Una concentración de aspartato transaminasa (AST), alanina transaminasa (ALT) o de bilirrubina total > 2 veces el límite superior de la normalidad (LSN) en la selección (día -7 y ampliación).
    17. Una concentración de nitrógeno ureico en la sangre > 50 mg/dl (>17,85 mmol/L) o una concentración de creatinina sérica > 1,3 mg/dl (>115umol/L) en la selección (día -7 y ampliación).
    18. Una concentración de amilasa sérica > 1,5 veces el LSN o una concentración de lipasa sérica > 2 veces el LSN en la selección (día -7 y ampliación).
    19. Antecedentes de abuso de o dependencia de sustancias en el último año, según lo definido por los criterios del Manual diagnóstico y estadístico de los trastornos mentales (Diagnostic and Statistical Manual of Mental Disorders, DSM V).
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants achieving insulin independence, defined as use of exogenous insulin of ? 0.2 units/kg body weight/day and hemoglobin A1c < 6.5%, with the combination therapy of cyclosporine and omeprazole versus omeprazole alone in participants with new onset type 1 diabetes at 24 weeks.
    La proporción de participantes que logren independencia de la insulina, definida como el uso de insulina exógena de ? 0,2 unidades/kg de peso corporal por día y hemoglobina A1c (A1C) < 6,5%, con el tratamiento asociado de ciclosporina y omeprazol , en comparación con omeprazol solo, en participantes con diabetes de tipo 1, de aparición reciente, a las 24 semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks after the start of investigational therapy
    24 semanas despues del comienzo del tratamiento experimental
    E.5.2Secondary end point(s)
    ?Safety and tolerability by collection of adverse events (AEs), serious adverse events (SAEs), hematology and serum chemistry, urinalysis, ECGs, and vital signs.
    ?Pancreatic beta cell function measured by plasma C-peptide response to a glucagon stimulated test for combination therapy of cyclosporine and omeprazole versus omeprazole alone versus no treatment (historical controls) in participants with new onset type 1 diabetes at 24 weeks.
    ?Proportion of participants achieving insulin independence with the combination therapy of cyclosporine and omeprazole versus no treatment (historical controls) andomeprazole alone versus no treatment (historical controls) in participants with new onset type 1 diabetes at 24 weeks.
    ?Blood glucose control measured by hemoglobin A1c (A1C) for combination therapy of cyclosporine and omeprazole versus omeprazole alone versus no treatment (historical controls).
    ?Average daily insulin requirement per week calculated as insulin units/kg body weight/day
    ?Blood glucose monitoring using Continuous Glucose Monitoring (CGMS) for 1 week at Week 4 and at Week 24.
    ?Changes in Immune Markers as analyzed by flow cytometry.
    ?Safety, tolerability, efficacy, and immune markers in participants randomized to a lower concentration of cyclosporine in the study extension.
    ? La seguridad y la tolerabilidad, mediante la recogida de los acontecimientos adversos (AA), los acontecimientos adversos graves (AAG), los parámetros hematológicos, los parámetros bioquímicos del suero, el análisis de orina, el ECG y las constantes vitales.
    ? La función de las células beta del páncreas, medida mediante la respuesta del péptido C plasmático a una prueba estimulada por glucagón en el caso del tratamiento asociado de ciclosporina y omeprazol, en comparación con omeprazol solo, en comparación con la ausencia de tratamiento (grupo de referencia histórico), en participantes con diabetes de tipo 1, de aparición reciente, a las 24 semanas.
    ? La proporción de participantes que logren la independencia de la insulina con el tratamiento asociado de ciclosporina y omeprazol, en comparación con la ausencia de tratamiento (grupo de referencia histórico), y omeprazol solo, en comparación con la ausencia de tratamiento (grupo de referencia histórico), en participantes con diabetes de tipo 1, de aparición reciente, a las 24 semanas.
    ? La determinación de la glucemia, medida mediante la hemoglobina A1c (A1C), en el caso del tratamiento asociado de ciclosporina y omeprazol, en comparación con omeprazol solo, en comparación con la ausencia de tratamiento (grupo de referencia histórico).
    ? El uso diario de insulina por semana, calculado como unidades de insulina/kg de peso corporal al día.
    ? La determinación de la glucemia, mediante la vigilancia continua de glucosa (Continuous Glucose Monitoring, CGMS) durante una semana, en las semanas 4 y 24.
    ? La cantidad de episodios de hipoglucemia.
    ? Los cambios en los marcadores inmunológicos analizados mediante la citometría de flujo.
    ? La seguridad, la tolerabilidad, la eficacia y los marcadores inmunológicos en los participantes aleatorizados a una concentración más baja de ciclosporina en la ampliación del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks after the start of investigational therapy
    24 semanas despues del comienzo del tratamiento experimental
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Controles historicos sin tratar
    Untreated historical controls
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Israel
    Italy
    Spain
    E.8.7Trial has a data monitoring committee No
    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
    Ultima visita de seguimiento del ultimo paciente reclutado
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 41
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 81
    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)
    Ss (regardless of arm) insulin independent (as use of insulin of ?0.2 units/kg body weight/day) at 24 wks and meeting inclusion criteria may continue on to the Extension for up to an additional 48 weeks. In particular Ss of Arm 1, insulin independent at Week 48, during the Extension will be randomized 1:1 to either 1) continue the dose of cyclosporine with target trough levels of 250-300 ng/ml or 2) reduce the dose of cyclosporine by 10%/week to achieve a target trough levels of 150-200 ng/ml.
    Sujetos (independientemente de grupo) insulino-independientes (uso insulina de ?0.2 u/kg/día) a 24 semanas y que cumplan criterios de inclusión pueden continuar en extensión hasta máx. de 48 semanas adicionales. Sujetos del Grupo 1, insulino-independientes en la semana 48, durante la extensión se asignará (1:1) a 1) continuar con dosis de ciclosporina con niveles mínimos de 250 a 300 ng/ml o 2) reducir dosis de ciclosporina 10%/semana para lograr niveles mínimos de 150 a 200 ng/ml.
    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 Decision2015-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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