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    Summary
    EudraCT Number:2011-000261-12
    Sponsor's Protocol Code Number:CNTO328MDS2001
    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:2011-07-01
    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 number2011-000261-12
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter
    Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus
    Best Supportive Care in Anemic Subjects with International Prognostic
    Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome
    Ensayo fase 2, multicéntrico, aleatorizado, doble ciego y controlado con placebo para comparar siltuximab más la mejor terapia de soporte con placebo más la mejor terapia de soporte en sujetos anémicos con síndrome mielodisplásico de riesgo bajo o intermedio-1 conforme al sistema de clasificación IPSS (International Prognostic Scoring System)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    A.4.1Sponsor's protocol code numberCNTO328MDS2001
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group, Archimedesweg, 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number..31 071 524 21 66.
    B.5.5Fax number..31 071 524 21 10.
    B.5.6E-mailClinicalTrialsEU@jnj.its.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.3.1Product nameSiltuximab
    D.3.2Product code CNTO328
    D.3.4Pharmaceutical form Powder for solution for infusion
    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.3.8INN - Proposed INNSiltuximab
    D.3.9.2Current sponsor codeCNTO328
    D.3.9.3Other descriptive nameAnti IL-6 quimérico múrido-humano
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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) 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 Yes
    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 typeAnticuerpo monoclonal
    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 placeboPowder for solution for infusion
    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
    Anemia associated with Low- or Intermediate-1-Risk Myelodysplastic
    Syndrome
    Tratamiento de la anemia asociada a síntrome mielodisplástico de riesgo Bajo o Intermedio-1
    E.1.1.1Medical condition in easily understood language
    NA
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10028534
    E.1.2Term Myelodysplastic syndrome NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10002272
    E.1.2Term Anemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic 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
    The primary objective is to assess the clinical efficacy of siltuximab,
    demonstrated by a reduction in RBC transfusions to treat the anemia of
    MDS.
    El objetivo principal es evaluar la eficacia clínica del siltuximab, demostrada por una reducción de las transfusiones de eritrocitos para tratar la anemia asociada al SMD.
    E.2.2Secondary objectives of the trial
    • To demonstrate symptomatic improvement of subjects treated with
    siltuximab compared with the placebo group
    • To compare the number of RBC units transfused to treat the anemia of
    MDS, and the proportion of subjects treated with siltuximab who do not
    require a RBC transfusion to treat the anemia of MDS, from Week 5 to
    Week 12, compared with the placebo group
    • To assess the change in hemoglobin among MDS subjects treated with
    siltuximab compared with the placebo group
    • To compare disease progression (proportion of bone marrow blasts
    and cytogenetic change) for subjects treated with siltuximab compared
    with the placebo group
    • To assess the safety profile of siltuximab and RBC transfusions among
    subjects with Low- or Intermediate-1 (INT-1)-risk MDS
    • To assess the pharmacodynamics, pharmacokinetics, and antibodies
    to siltuximab (immunogenicity) in MDS subjects
    •See protocol for additional objectives
    Demostrar mejoría síntomas de sujetos con siltuximab frente a placebo. Comparar el nº unidades de eritrocitos transfundidas para tratar anemia asociada a SMD y proporción sujetos en siltuximab que no precisan transfusión de eritrocitos para tratar la anemia asociada al SMD, entre Semanas 5 y 12, frente a placebo. Cambio de hemoglobina en sujetos con SMD tratados con siltuximab y placebo. Comparar progresión enfermedad (%blastocitos en médula ósea y cambio citogenético) en sujetos con siltuximab frente a placebo. Evaluar perfil seguridad de siltuximab y de las transfusiones de eritrocitos en sujetos con SMD de riesgo Bajo o INT-1. Evaluar PD, PK y anticuerpos contra siltuximab (inmunogenia) en sujetos SMD. Investigar perfil de biomarcadores que pronostique la respuesta al siltuximab en sujetos SMD. Realizar validación inicial de encuesta de pacientes (NCA-SS). Evaluar utilización de recursos y productividad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age (or the legal age of consent in the jurisdiction
    in which the study is taking place)
    2. Confirmed diagnosis of MDS, according to WHO or FAB pathologic
    classification, with an IPSS score 0, 0.5, or 1.0, indicating Low- or INT-1-
    risk disease. Subjects with 5q- or PDGFR gene mutations are eligible if
    they are intolerant to or have failed prior specific therapy (eg,
    lenalidomide and imatinib mesylate).
    3. Documented RBC transfusion of at least 2 units of RBC for the
    treatment of the anemia of MDS in the 8 weeks preceding the start of the
    Screening Period.
    4. Adequate iron stores, demonstrated by either the presence of
    stainable iron in the bone marrow or a serum ferritin of > 100 ng/mL
    5. ECOG performance status score of 0 to 2
    6. Symptomatic anemia (defined by a score > 0 on the NCA-SS).
    7. Women of childbearing potential must agree to use adequate birth
    control measures during the study and for 3 months after receiving the
    last dose of study agent, and have a negative serum or urine beta human
    chorionic gonadotropin (beta hCG) pregnancy test at screening. Men
    must agree to use a double barrier method of birth control and to not
    donate sperm during the study and for 3 months after receiving the last
    dose of study agent
    8.Be willing and able to adhere to the prohibitions and restrictions
    specified in this protocol
    9.Sign (or their legally acceptable representatives must sign) an
    informed consent document indicating that they understand the purpose
    of and procedures required for the study and are willing to participate in
    the study.
    1. Al menos 18 años de edad (o la edad legal para consentir en la jurisdicción donde se esté llevando a cabo el estudio).
    2. Diagnóstico confirmado de SMD, según la clasificación anatomopatológica FAB o de la OMS, con una puntuación IPSS de 0, 0,5 o 1,0, que indica una enfermedad de riesgo bajo o INT-1. Los sujetos con mutaciones génicas de 5q o PDGFR podrán participar si presentan intolerancia o no han respondido a un tratamiento específico previo (por ejemplo, lenalidomida y mesilato de imatinib).
    3. Transfusión documentada de al menos 2 unidades de eritrocitos para el tratamiento de la anemia asociada al SMD en las 8 semanas previas al comienzo del período de selección.
    4. Depósitos de hierro suficientes, confirmados por la presencia de hierro tingible en la médula ósea o un valor de ferritina sérica > 100 ng/ml.
    5. Puntuación de capacidad funcional del ECOG entre 0 y 2.
    6. Anemia sintomática (definida por una puntuación > 0 en el cuestionario NCA-SS).
    7. Las mujeres con capacidad reproductiva deben comprometerse a utilizar métodos anticonceptivos adecuados durante el estudio y durante los 3 meses siguientes a la última dosis del fármaco del estudio y tener un resultado negativo de una prueba de embarazo basada en la subunidad beta de la gonadotropina coriónica humana (&#946;-hCG) en suero u orina en la visita de selección. Los varones deberán comprometerse a utilizar un método anticonceptivo de doble barrera y a no donar semen durante el estudio y durante 3 meses después de recibir la última dosis del fármaco del estudio.
    8. Ser capaz y estar dispuesto a cumplir las prohibiciones y restricciones especificadas en este protocolo.
    9. Los sujetos (o sus representantes legales) deben firmar un documento de consentimiento informado que indique que entienden el objetivo del estudio y los procedimientos que exige y que están dispuestos a participar en él.
    E.4Principal exclusion criteria
    1.Had treatment with ESAs, androgens, hypomethylating agents,
    immunomodulatory drugs (IMiDs), or other agents targeting IL-6 or its
    receptor within 4 weeks of randomization
    2.Any condition that, in the opinion of the investigator, would make
    participation not be in the best interest (eg, compromise the well-being)
    of the subject or that could prevent, limit, or confound the
    protocolspecified
    assessments (eg, has a history of clinically significant,
    uncontrolled disease of the pulmonary, cardiovascular, endocrine,
    neurologic, gastrointestinal, or genitourinary systems that is not
    attributable to MDS). Subjects with Chronic Myelomonocytic Leukemia
    (CMML) are to be excluded from the study.
    3.Causes other than MDS contributing to anemia, such as Vitamin B12 or
    folate deficiency, bleeding, hemolysis, hemoglobinopathy, or chronic
    renal failure
    4.Known unmanageable allergies, hypersensitivity, or intolerance to
    monoclonal antibodies or to murine, chimeric, or human proteins or their
    excipients
    5.A history of seropositivity for human immunodeficiency virus (HIV),
    hepatitis B virus (HBV), or hepatitis C virus (HCV) (Note: HBV
    antibodypositivity
    is not a reason for exclusion from the study)
    6.Received an investigational drug (including investigational vaccines)
    or used an invasive investigational medical device within 30 days or 5
    half lives before randomization or is currently enrolled in an
    investigational study
    7.Had a modification of an effective preexisting therapy for the explicit
    purpose of entering the study.
    8.Is a woman who is pregnant, or breast-feeding, or planning to become
    pregnant or is a man who plans to father a child while enrolled in this study or within 12 weeks after the last dose of study agent
    9.Had hospitalization for infection or major surgery, (eg, requiring
    general anesthesia) within 2 weeks before randomization or will not
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    have fully recovered from surgery.
    Note: subjects with planned surgical procedures to be conducted under
    local anesthesia may participate
    10.Been vaccinated with live, attenuated vaccines within 4 weeks of
    randomization
    11.Has clinically significant laboratory abnormalities:
    •Platelets < 20 x 109/L
    •Estimated glomerular filtration rate (eGFR) <=20 mL/min
    •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≥
    2.5 x upper limit of normal (ULN)
    •Bilirubin > 2.5 x ULN
    •Alkaline phosphatase ≥ 3 x ULN
    12.Is an employee of the investigator or study site, with direct
    involvement in the proposed study or other studies under the direction
    of that investigator or study site, as well as family members of the
    employees or the investigator
    NOTE: Investigators should ensure that all study enrollment criteria
    have been met at screening. If a subject's status (including laboratory
    results) changes after screening but before the first dose of study agent
    is given such that they now meet an exclusion criterion, then they should
    be excluded from participation in the study.
    1. Ha recibido tratamiento con FEE (fármacos estimuladores de la eritropoyesis), andrógenos, fármacos hipometilantes, fármacos inmunomoduladores (FIM) u otros fármacos que actúen sobre la IL 6 o su receptor en las 4 semanas previas a la aleatorización.
    2. Cualquier condición que, a juicio del investigador, haría que la participación en el estudio no fuera lo mejor (por ejemplo, compromiso del bienestar) para el paciente o que podría impedir, limitar o generar confusión en las evaluaciones especificadas en el protocolo (por ejemplo, antecedentes de enfermedad clínicamente significativa e incontrolada de los sistemas pulmonar, cardiovascular, endocrino, nervioso, digestivo o aparato genitourinario no atribuible al SMD). Los sujetos con leucemia mielomonocítica crónica (LMMC) deben ser excluidos del estudio.
    3. Causas distintas del SMD que contribuyen a la anemia, como el déficit de vitamina B12 o folato, hemorragia, hemólisis, hemoglobinopatía o insuficiencia renal crónica.
    4. Alergias, hipersensibilidad o intolerancia conocidas y no controlables a anticuerpos monoclonales, a proteínas múridas, quiméricas o humanas o a sus excipientes.
    5. Antecedentes de seropositividad para el virus de la inmunodeficiencia humana (VIH), el virus de la hepatitis B (VHB) o el virus de la hepatitis C (VHC). (Nota: la positividad para anticuerpos contra el VHB no es motivo de exclusión del estudio).
    6. Haber recibido un fármaco experimental (incluidas las vacunas experimentales) o haber utilizado un producto sanitario experimental invasivo en los 30 días o 5 semividas previos a la aleatorización o participar actualmente en un estudio de investigación.
    7. Haber modificado un tratamiento previo eficaz con la finalidad expresa de participar en el estudio.
    8. Ser una mujer que está embarazada, esta amamantando o tiene intención de quedarse embarazada o es un varón que planea tener un hijo durante su participación en este estudio o en las 12 semanas siguientes a la última dosis del fármaco del estudio.
    9. Haber sido hospitalizado a causa de una infección o cirugía mayor (por ejemplo, con necesidad de anestesia general) en las 2 semanas previas a la aleatorización o no habrerse recuperado totalmente de la cirugía.
    Nota: podrán participar los sujetos con intervenciones quirúrgicas programadas que se llevarán a cabo bajo anestesia local.
    10. Haber sido vacunado con vacunas de virus vivos atenuados durante las 4 semanas previas a la aleatorización.
    11. Presentar anomalías analíticas clínicamente significativas:
    Plaquetas < 20 x 109/l
    Índice de filtración glomerular estimado (IFGe) 20 ml/min
    Aspartato-aminotransferasa (AST)/alanina-aminotransferasa (ALT) 2,5 x límite superior de la normalidad (LSN)
    Bilirrubina > 2,5 x LSN
    Fosfatasa alcalina 3 x LSN
    12. Ser empleado del investigador o del centro de estudio con participación directa en el estudio propuesto o en otros bajo la dirección de ese investigador o centro de estudio, así como los familiares de los empleados o del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Proporción de sujetos que consigan una reducción de transfusiones.Se evaluará en un intervalo de 8 semanas, de la 5 a la 12. Los criterios secundarios: valoracón de hemoglobina(en la semana 12) , examen aspirado médula (en la Semana 13 y cada 24 semanas durante el tratamiento) y valoración de síntomas de la anémia (a diario durante 12 semanas, depues mensual para el resto del periodo de tratamiento).
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 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 Yes
    E.8.1.7.1Other trial design description
    Abierto,continua hasta fallecimiento,aparición toxicidad inaceptable,retirada CI o limite clinico
    Open; study will continue until death, unacceptable toxicity, withdraw
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Australia
    Belgium
    Netherlands
    Russian Federation
    Spain
    Sweden
    United States
    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
    El limite clínico es 24 semanas después de la aleatorización del último paciente. El fin del estudio se alcanzará 36 semanas después de la aleatorización 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 months0
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 75
    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 Decision2011-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-09-13
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