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    Summary
    EudraCT Number:2006-006175-20
    Sponsor's Protocol Code Number:UC-0110/0608
    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:2012-12-17
    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 number2006-006175-20
    A.3Full title of the trial
    Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
    Ensayo en fase III evaluando la función de la quimiohipertermia intraperitoneal intraoperatoria (CHIP) después de una resección máxima en carcinomatosis peritoneal de origen colorrectal asociado con quimioterapia sistémica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
    Ensayo en fase III evaluando la función de la quimiohipertermia intraperitoneal intraoperatoria (CHIP) después de una resección máxima en carcinomatosis peritoneal de origen colorrectal asociado con quimioterapia sistémica.
    A.3.2Name or abbreviated title of the trial where available
    PICH
    CHIP
    A.4.1Sponsor's protocol code numberUC-0110/0608
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUNICANCER
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnicancer
    B.5.2Functional name of contact pointBEATA JUZYNA
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number+33144 23 55 67
    B.5.5Fax number+33144 23 55 69
    B.5.6E-mailb-juzyna@unicancer.fr
    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 ELOXATINE®
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameELOXATINE®
    D.3.2Product code NON APPLICABLE
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxaliplatine
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 FOLINATO CÁLCICO
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS NORMON S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCalcium Lévofolinate
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcide folinique
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 3
    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 FLUOROURACILO
    D.2.1.1.2Name of the Marketing Authorisation holderFERRER FARMA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameFluorouracile
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluorouracile
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
    Pacientes que tendrán una cirugía de citoreducción máxima por una carcinomatosis peritoneal de origen colorrectal
    E.1.1.1Medical condition in easily understood language
    Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
    Pacientes que tendrán una cirugía de citoreducción máxima por una carcinomatosis peritoneal de origen colorrectal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052171
    E.1.2Term Peritoneal carcinoma
    E.1.2System Organ Class 100000004864
    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 overall survival in patients affected with peritoneal carcinosis of
    colorectal origin and having undergone a macroscopically complete or suboptimal (with unresected residual tumor tissues ? 1mm) surgical resection and benefiting from a maximized treatment with chemotherapy (i.e.: maximal surgery + chemohyperthermia + pre- or post-operatory systemic chemotherapy) or a maximized treatment without chemohyperthermia (i.e.: maximal surgery + pre-or post-operatory systemic chemotherapy).
    Comparar la supervivencia global en pacientes con carcinomatosis peritoneal de origen colorrectal que hayan sido sometidos a una cirugía citoreductora completa macroscópicamente o subóptima (residuo tumoral menor de 1 mm) , complementándola con quimiohipertermia y quimioterapia sistémica o bien , sólo con quimioterapia sistémica.
    E.2.2Secondary objectives of the trial
    ?Evaluate recurrence-free survival of these patients.
    ?Evaluate treatment toxicities.
    ?Determine morbidity from surgical complications.
    ?Determine prognostic factors of survival.
    - Evaluar la supervivencia sin recidiva
    -Evaluar la toxicidad del tratamiento (CTC-AE v3.0)
    -Evaluar la tasa de morbilidad
    -Evaluar los factores pronósticos de supervivencia
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    nutrition and digestive surgery study: aim:
    patient nutrition evaluation treated for a peritoneal carcinomatosis before and 3 months after the surgery.
    Correlation between nutritional status and complications
    to mesure specific morbidity
    To study patient evolution
    -Estudio sobre nutrición y cirugía digestiva: objetivos:
    -evaluación nutricional de los pacientes en tratatmiento por una carcinomatosis peritoneal antes y 3 meses después de la cirugía
    -Correlación entre estado nutricional y complicaciones
    -Medir la morbilidad más específicamente
    -Estudiar la evolución de los pacientes
    E.3Principal inclusion criteria
    1) Histologically confirmed colorectal cancer,
    2) Minimal or moderate peritoneal carcinosis with a Sugarbaker peritoneal score ? à 25 (see
    annex 9), (peroperatory assessment),
    3) A surgically obtained tumor reduction, macroscopically complete R1 or with a residual
    thickness not exceeding 1 mm (R2), (peroperatory assessment)
    4) Absence of extra peritoneal metastases including hepatic and pulmonary metastases (
    confirmed by a PET scan, if possible),
    5) Patient to be treated by systemic chemotherapy for its carcinosis,
    6) 18 ? age ? 70 yo,
    7) WHO performance status ? 1,
    8) Life expectancy > 12 weeks,
    9) Adequate hematological function: polynuclear neutrophiles ? 1,5x10
    9
    /L, platelets ? 100x10
    9
    /L,
    10) Adequate hepatic function : total bilirubin ? 1,5 x ULN, ASAT (SGOT) and ALAT (SGPT) ? 3 x
    ULN, alkaline phosphatases ? 3 x ULN,
    11) Seric creatinine ? 1,25 x ULN,
    12) Operable patient,
    13) Peripheral neuropathy with grade ? 3 (CTC AE v3.0 annex 7)
    14) Patient information and written informed consent form signed before any protocol specific
    procedure is started.
    15) Patient is affiliated with a proper/French national health insurance fund
    1) Cáncer colorrectal histológicamente demostrado
    2) Carcinomatosis peritoneal de extensión leve o moderada , con un Score de extensión peritoneal de Sugarbaker menor a 25( Anexo 9) ( Evaluación intraoperatoria)
    3) La obtención de una citorreducción quirúrgica macroscópicamente completa ( R1 ) o residuo tumoral no superior a 1 mm (R2), (evaluación intraoperatoria)
    4) Ausencia de metástasis extraperitoneales, incluyendo metástasis hepáticas y pulmonares(si es posible confirmadas por la práctica de un PET)
    5) Haber recibido tratamiento con quimioterapia sistémica.
    6) Edad comprendida entre 18 y 70 años
    7) Performance status OMS ≤ 1
    8) Esperanza de vida> 12 semanas
    9) Función hematológica: PNN ≥1,5 x 109/L, plaquetas 100x109/L,
    10) Función hepática: bilirrubina total sin sobrepasar 1.5 veces los valores normales, AST (SGOT) y ALT (SGPT) sin sobrepasar 3 veces los valores normales.
    11) creatinina plasmática sin sobrepasar 1.25 veces los valores normales.
    12) Pacientes operables
    13) Neuropatía periférica de grado 3 (CTC AE v 3.0, Anexo 7)
    14) Información al paciente y firma de un consentimiento informado antes de cualquier procedimiento especifico del estudio
    15) Afiliación a un régimen de seguridad social.
    E.4Principal exclusion criteria
    1) Carcinosis of other-than-colorectal origin, specifically appendiculary carcinomas,
    2) Large volume carcinosis with Sugarbaker peritoneal-extent score >25 (annex 9), (peroperatory
    assessment)
    3) Patient has already been treated by chemohyperthermia
    4) History of previous cancer (except cutaneous basocellular carcinoma or in situ carcinoma of
    the uterine cervix) with a relapse occurred within the 5-year period prior to inclusion,
    5) Patient already included in another first-line therapeutic trial aimed at the same disease study,
    6) Pregnant women, women who are likely to become pregnant or are breast-feeding,
    7) Individual deprived of liberty or placed under the authority of a tutor,
    8) Patients with any psychological, familial, sociological or geographical condition potentially
    hampering compliance with the study protocol and follow-up schedule.
    1) Carcinomatosis de cualquier otro origen, en particular el carcinoma apendicular.
    2) Carcinomatosis peritoneal de extensión grave, con un Score de extensión peritoneal de Sugarbaker > 25 ( Anexo 9) (evaluación intraoperatoria)
    3) Pacientes tratados previamente con quimiohipertermia
    4) Antecedentes de cáncer (excepto el carcinoma de basocelular cutáneo o carcinoma in situ de cuello uterino) con recaída en los 5 años previos a la entrada en el estudio.
    5) Paciente incluido en otro ensayo clínico de primera línea para la enfermedad estudiada
    6) Embarazo (o sospecha del mismo), periodo de lactancia.
    7) Las personas privadas de libertad o bajo tutela,
    8) Incapacidad para someterse a examen médico por razones geográficas, sociales o psicológicas.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival will be taken into account. Estimate of the median survival is 30 months in the
    control group. The trial objective is to increase the median survival time to 48 months using the
    experimental treatment PICH (hazard ratio = 0.625).
    Se evaluará principalmente la supervivencia global. La media de supervivencia está estimada en 30 meses en el grupo control. El objetivo es aumentar la media de supervivencia hasta alcanzar los 48 meses en el tratamiento experimental CHIP (hasard ratio= 0,625)
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 years
    7 años
    E.5.2Secondary end point(s)
    Survival without relapse : the following cases will be considered as relapse :
    - Histologically confirmed relapse or a suggestive context (palpable nodules, visible on
    imaging, with concomitant elevation of significant markers)
    - Distant relapse (evident on imaging or Histologically confirmed),
    - Any patient's death.

    Treatment toxicity : according to the CTC AE v3.0 scale (annex 7)
    Surgical complications :
    - Abdominal complications : (digestive fistula, urinary fistula, deep abscess without fistula,
    hemoperitoneum, number of percutaneous drainages)
    - Extra-abdominal complications: (pulmonary, infectious urinary, central catheter infection,
    venous (thrombo-embolic), parietal, renal insufficiency, cardiac disorders)
    - Aplasia: postoperatory, febrile aplasia or other non-febrile complications.

    Morbidity :
    - Patients' deaths occurring within 60 days following surgery,
    - Serious hemorrhages (> 30 % of blood volume),
    - Serious hemodynamic impairments,
    - Any visceral impairments, notably :
    o Renal insufficiency or rhabdomyolysis requiring dialysis.
    o Respiratory impairment requiring assisted ventilation = 2 days.
    o Hepatic impairment: bilirubine > 10 N.
    o Serious neurophysiological and motricity disorders.
    - Parenteral feeding at home > 1 month,
    - Any infectious complication (locoregional infection, abscess drainage?.)
    - Grade 4 thrombopenia (< 25 000), Neutropenia < 500 PN, blood transfusion > 4 CG,
    Diarrheas > 15 times/day and beyond D21, serious decrease of auditive capacity,
    - Any SAE putting the vital prognosis at stake or causing permanent invalidity or
    serious temporary incapacity.
    -Survival prognostic factors
    1- Supervivencia sin recidiva, siendo consideradas recidivas:
    - Recidiva peritoneal demostrada histológicamente o contexto clínico muy sugestivo (Nódulos palpables o hallados en prueba de imagen con elevación concomitante de marcadores tumorales).
    - Recidiva a distancia (evidente en la iconografía o comprobada histológicamente)
    - Las muertes por todas las causas.
    2- La toxicidad del tratamiento: de acuerdo con CTC AE v3.0 (Anexo 7)
    3- Complicaciones quirúrgicas:
    - Complicaciones abdominales (Fístula digestiva, fístula urinaria, absceso profundo sin fístula, hemoperitoneo, número de drenajes percutáneos)
    - Complicaciones extra-abdominales: (pulmonares, infección urinaria, infección del catéter central, venosas (tromboembolismo), parietal, insuficiencia renal, cardiacas)
    - Aplasia postoperatoria, aplasia febril o complicaciones no febriles.
    3- Morbilidad:
    - Mortalidad en los 60 días después de la cirugía,
    - Sangrado severo (> 30% del volumen sanguíneo)
    - Inestabilidad hemodinámica severa,
    - Toda insuficiencia orgánica, en especial,
    Insuficiencia renal o rabdomiolisis que requiera diálisis
    Fracaso respiratorio que requiera ventilación asistida = 2 días
    Insuficiencia hepática : bilirrubina> 10 N.
    Alteraciones cerebro-motoras graves
    - Nutrición parenteral > 1 mes a domicilio
    - Cualquier complicación infecciosa (infección locorregional, drenaje de abscesos ....)
    - Trombocitopenia grado 4 (<25 000), neutropenia <500 PN, transfusión> 4 concentrados de hematíes, diarrea > 15 deposiciones / día más allá del día 21 hipoacusia severa
    -Todos los efectos adversos graves que comprometan la vida o provoquen una invalidez permanente o una incapacidad temporal grave.
    4- Factores pronósticos de supervivencia
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 years
    7 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 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) No
    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 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 Yes
    E.8.2.3.1Comparator description
    maximal surgery without chemohyperthermia
    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 EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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 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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    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 No
    F.3.3.7Others Information not present in EudraCT
    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 264
    F.4.2.2In the whole clinical trial 264
    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)
    Medical control every 6 months
    controles médicos cada 6 meses
    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 Decision2013-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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