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    Summary
    EudraCT Number:2011-005226-21
    Sponsor's Protocol Code Number:ARD12181
    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:2012-01-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-005226-21
    A.3Full title of the trial
    A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated with Ruxolitinib and with a Current Diagnosis of Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
    Estudio Fase 2, multicéntrico, abierto, de un solo brazo de tratamiento con SAR302503 en pacientes previamente tratados con Ruxolitinib y con un diagnóstico actual de Mielofibrosis Primaria o Mielofibrosis post-Policitemia vera o Mielofibrosis post-Trombocitemia esencial, de riesgo intermedio-2 o alto riesgo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated with Ruxolitinib and with a Current Diagnosis of Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
    Estudio Fase 2, multicéntrico, abierto, de un solo brazo de tratamiento con SAR302503 en pacientes previamente tratados con Ruxolitinib y con un diagnóstico actual de Mielofibrosis Primaria o Mielofibrosis post-Policitemia vera o Mielofibrosis post-Trombocitemia esencial, de riesgo intermedio-2 o alto riesgo
    A.4.1Sponsor's protocol code numberARD12181
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1124-0967
    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 SponsorSanofi-aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointCSU Director
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 93 485 9466
    B.5.5Fax number+34 93 489 5466
    B.5.6E-mailbibiana.figueres@sanofi-aventis.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/810 and EU/3/10/811 and EU/3/10/794
    D.3 Description of the IMP
    D.3.2Product code SAR302503
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeSAR302503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Hematopoietic neoplasm
    Neoplasia hematopoyética
    E.1.1.1Medical condition in easily understood language
    Hematopoietic neoplasm
    Neoplasia hematopoyética
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018864
    E.1.2Term Haematopoietic neoplasm NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles
    ? Evaluar la eficacia de una dosis diaria de SAR302503 en sujetos tratados previamente con ruxolitinib y con un diagnóstico actual de mielofibrosis primaria (MFP), mielofibrosis post-policitemia vera (MF-PPV) o mielofibrosis post-trombocitemia esencial (MF-PTE), de riesgo intermedio-2 o alto, en función de la reducción del volumen esplénico al final de 6 ciclos de tratamiento.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
    To evaluate the durability of splenic response
    To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
    To evaluate the splenic response to SAR302503 through the first 6 treatment cycles
    To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
    To evaluate the safety and tolerability of SAR302503 in this population
    To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted
    ? Evaluar el efecto de SAR302503 sobre los síntomas asociados a la mielofibrosis (MF), determinado mediante el diario del Formulario modificado de evaluación de los síntomas de Mielofibrosis (Myelofibrosis Symptom Assessment Form ? MFSAF).
    ? Evaluar la duración de la respuesta esplénica.
    ? Evaluar la respuesta esplénica a SAR302503 mediante palpación al final del Ciclo 6.
    ? Evaluar la respuesta esplénica a SAR302503 a lo largo de los 6 primeros ciclos de tratamiento.
    ? Evaluar el efecto de SAR302503 sobre la carga alélica de la mutación V617F del gen Janus Kinase 2 (JAK2).
    ? Evaluar la seguridad y la tolerabilidad de SAR302503 en esta población.
    ? Evaluar las concentraciones plasmáticas de SAR302503 para el análisis farmacocinético poblacional, si está justificado.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetic, 20-Oct-2011, version 1
    To determine a possible relationship between genes and responses to treatment with Drug SAR302503, how the body processes Drug SAR302503 and possible side effects to Drug SAR302503.
    Farmacogenético, 20-oct-2011, version 1
    Determinar la posible relación entre los genes y la respuesta al tratamiento con SAR302503, cómo el cuerpo metaboliza el SAR302503 y posibles efectos secundarios SAR302503.
    E.3Principal inclusion criteria
    Diagnosis of PMF or Post-PV MF or Post-ET MF, according to the 2008 World Health Organization and IWG-MRT response criteria
    Subjects who previously received Ruxolitinib treatment for PMF or Post-PV MF or Post-ET MF or PV or ET for at least 14 days and discontinued the treatment for at least 30 days prior to study entry
    MF classified as high-risk or intermediate-risk level 2 (IWG-MRT response criteria IPSS assess myelofibrosis score, Cervantes, et al, Blood 2009)
    Spleen ?5 cm below costal margin as measured by palpation
    Male and female subjects ?18 years of age
    Signed written informed consent.
    I 01. Diagnóstico de MFP, MF-PPV o MF-PTE, según los criterios de 2008 de la Organización Mundial de la Salud (Anexo B) y de los criterios del IWG-MRT (Anexo C).
    I 02. Sujetos que recibieron tratamiento previo con ruxolitinib para MFP, MF-PPV, MF-PTE, PV o TE durante al menos 14 días y lo terminaron al menos 30 días antes de la inclusión en el estudio.
    I 03. Mielofibrosis clasificada como de riesgo alto o intermedio-2 según la puntuación para la MF en el IPI aplicando los criterios de respuesta del IWG-MRT (Cervantes y cols., Blood 2009 [1]).
    I 04. Bazo ? 5 cm por debajo del borde costal a la palpación.
    I 05. Varones y mujeres ? 18 años.
    I 06. Consentimiento informado por escrito firmado.
    E.4Principal exclusion criteria
    Splenectomy
    Eastern Cooperative Oncology Group (ECOG) performance status of >2 at study entry
    The following laboratory values within 14 days prior to the initiation of SAR302503:
    Absolute Neutrophil Count (ANC) <1.0 x 10exp9/L
    Platelet count <50 x 10exp9/L
    Serum creatinine >1.5 x Upper limit of normal (ULN)
    Serum amylase and lipase >1.5 x ULN
    Direct bilirubin >2.0 x ULN
    Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x ULN; higher values (ie, >5 x ULN) are allowed if clinically compatible with hepatic extramedullary hematopoiesis
    Subjects with any other prior malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 5 years
    Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of SAR302503; darbepoetin use within 28 days prior to initiation of SAR302503
    Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of SAR302503
    E 01. Estado funcional > 2 en el momento de inclusión en el estudio, según la escala del Eastern Cooperative Oncology Group (ECOG).
    E 02. Los siguientes resultados analíticos en los 14 días previos al inicio del tratamiento con SAR302503:
    ? Recuento absoluto de neutrófilos (RAN) < 1,0 x 109/l.
    ? Cifra de plaquetas < 50 x 109/l.
    ? Creatinina sérica > 1,5 x límite superior de la normalidad (LSN).
    ? Amilasa y lipasa séricas > 1,5 x LSN.
    E 03. Bilirrubina directa > 2,0 x LSN.
    E 04. Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 3 x LSN; se permiten valores superiores (> 5 x LSN) si son clínicamente compatibles con hematopoyesis extramedular hepática.
    E 05. Esperanza de vida < 6 meses.
    E 06. Los sujetos con cualquier otra neoplasia maligna previa no son aptos para su inclusión en el estudio, excepto en los siguientes casos: carcinoma cutáneo espinocelular o basocelular tratado adecuadamente, cáncer de cuello uterino in situ u otra neoplasia maligna de la que el paciente esté libre de enfermedad por lo menos durante 5 años.
    E 07. Falta de disposición o capacidad para ajustarse a las visitas programadas, los planes terapéuticos, las pruebas analíticas y otros procedimientos del estudio.
    E 08. Esplenectomía.
    E 09. Cualquier tratamiento con quimioterapia (p.ej., hidroxiurea); farmacoterapia con inmunomoduladores (p.ej., talidomida o interferón alfa); anagrelida; tratamiento con inmunodepresores; corticoesteroides > 10 mg/día de prednisona o equivalente; tratamiento con factores de crecimiento (p.ej., eritropoyetina) u hormonas (p.ej., andrógenos o danazol) recibido en los 14 días antes de iniciar la administración de SAR302503. Uso de darbepoetina en los 28 días previos al inicio del tratamiento con SAR302503.
    E 10. Cirugía mayor en los 28 días previos al inicio del tratamiento con SAR302503 o radiación en los 6 meses previos al inicio del tratamiento con SAR302503.
    E 11. Tratamiento concomitante con fármacos o plantas medicinales que se sepan que son inhibidores moderados o potentes o inductores del citocromo CYP3A4.
    E 12. Tratamiento con ácido acetilsalicílico en dosis > 150 mg/día durante una semana.
    E 13. Infección aguda activa que requiera el uso de antibióticos
    E 14. Insuficiencia cardíaca congestiva no controlada (Clase 3 o 4 según la clasificación de la New York Heart Association), angina de pecho, infarto de miocardio, accidente cerebrovascular, cirugía de revascularización coronaria/periférica, accidente isquémico transitorio o embolia pulmonar en los 3 meses previos al inicio del tratamiento con SAR302503.
    E 15. Participación en cualquier otro estudio de un agente en fase de investigación (fármaco, agente biológico o dispositivo) en los 30 días previos al inicio del tratamiento con SAR302503, excepto durante una fase de no tratamiento.
    E 16. Mujer embarazada o en período de lactancia.
    E 17. Mujer con posibilidad de quedar embarazada, a menos que utilice un método anticonceptivo eficaz durante la administración de SAR302503.
    E 18. Varón cuya pareja sea una mujer con posibilidad de quedar embarazada, a menos que accedan a utilizar un método anticonceptivo eficaz durante el tratamiento con SAR302503.
    E 19. Enfermedad conocida por el virus de la inmunodeficiencia humana o enfermedad relacionada con el síndrome de inmunodeficiencia humana.
    E 20. Hepatitis B o C clínicamente activa.
    E 21. Cualquier enfermedad psiquiátrica, neurológica o de otro tipo, crónica o aguda grave, o anomalía en las pruebas analíticas, que puedan aumentar el riesgo asociado a la participación en el estudio o a la administración de SAR302503; interferir en el proceso de consentimiento informado y/o en el cumplimiento de los requisitos del estudio; interferir en la interpretación de los resultados del estudio y que, en opinión del investigador, pudiera incapacitar al sujeto para participar en este estudio.
    E 22. Incapacidad para tragar cápsulas.
    E 23. Presencia de algún trastorno digestivo, o de otro tipo, que inhiba la absorción oral de la medicación.
    E.5 End points
    E.5.1Primary end point(s)
    Response Rate (RR), defined as the proportion of subjects who have a ?35% reduction from baseline in volume of spleen at the end of Cycle 6 as measured by Magnetic Resonance Imaging (MRI) (or CT scan in subjects with contraindications for MRI)
    Tasa de respuesta (TR), definida como el porcentaje de sujetos con una reducción del volumen del bazo con respecto al periodo basal ? 35 % al final del Ciclo 6, determinada mediante resonancia magnética (RM), o tomografía computarizada (TC) en sujetos en los que la RM esté contraindicada.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    - Symptom Response Rate (SRR): Proportion of subjects with a ?50% reduction from baseline to the end of Cycle 6 in the total symptom score using the modified MFSAF
    - Duration of spleen response, measured by MRI (or CT scan in subjects with contraindications for MRI)
    6 months
    - Proportion of subjects with a ?50% reduction in length of spleen by palpation from baseline at the end of Cycle 6
    - Response Rate by Cycle 6 (RR6), defined as the proportion of subjects who have a ?35% reduction from baseline in volume of spleen at any time up to Cycle 6 as measured by MRI (or CT scan in subjects with contraindications for MRI)
    - The effect of SAR302503 on the JAK2V617F allele burden
    - Safety, as assessed by clinical, laboratory, ECG, and vital sign events; graded by the NCI CTCAE v4.03
    - Plasma concentrations of SAR302503
    - Tasa de respuesta sintomática (TRS): porcentaje de sujetos con una reducción ? 50 % desde el periodo basal hasta el final del Ciclo 6 en la puntuación total del MFSAF modificado para la evaluación de los síntomas.
    - Duración de la respuesta esplénica, determinada mediante RM (o TC en sujetos en los que la RM esté contraindicada).
    - Porcentaje de sujetos con una reducción a la palpación ? 50 % en la longitud del bazo desde el periodo basal hasta el final del Ciclo 6.
    - Tasa de respuesta en el Ciclo 6 (TR6), definida como el porcentaje de sujetos con una reducción del volumen del bazo con respecto al periodo basal ? 35 % en cualquier momento hasta el Ciclo 6, determinado mediante RM (o TC en sujetos en los que la RM esté contraindicada).
    - El efecto de SAR302503 sobre la carga alélica de JAK2V617F.
    - Seguridad y tolerabilidad, evaluadas mediante la determinación de las constantes vitales, la realización de electrocardiogramas (ECG), analíticas y exploraciones físicas; utilizando de la escala CTCAE v4.03.
    - Concentraciones plasmáticas de SAR302503.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - For the 4 first secondary end points:
    6 months
    - The effect of SAR302503 on the JAK2V617F allele burden: 2 years
    - Safety, as assessed by clinical, laboratory, ECG, and vital sign events; graded by the NCI CTCAE v4.03: approx 5 years
    Plasma concentrations of SAR302503: 4 years
    - Para los 4 primeros criterios secundarios: 6 meses
    - El efecto de SAR302503 sobre la carga alélica de JAK2V617F: 2 años
    - Seguridad y tolerabilidad, evaluadas mediante la determinación de las constantes vitales, la realización de electrocardiogramas (ECG), analíticas y exploraciones físicas; utilizando de la escala CTCAE v4.03: aprox 5 años
    - Concentraciones plasmáticas de SAR302503: 4 años
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    United States
    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
    Última visita del último paciente
    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 months10
    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 months10
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 41
    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)
    NA
    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 Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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