Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36781   clinical trials with a EudraCT protocol, of which   6074   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-004499-23
    Sponsor's Protocol Code Number:LIVERHOPE_SAFETY
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-01-25
    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 number2016-004499-23
    A.3Full title of the trial
    Safety and tolerability of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis: a multicenter, double-blind, placebo controlled randomized clinical trial.
    Seguridad y tolerabilidad de la combinación de simvastatina y rifaximina en pacientes con cirrosis descompensada: ensayo clínico multicéntrico aleatorizado, doble-ciego, controlado con placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Simvastatin plus rifaximin in decompensated cirrhosis
    Simvastatina más rifaximina en cirrosis descompensada
    A.4.1Sponsor's protocol code numberLIVERHOPE_SAFETY
    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 SponsorIDIBAPS
    B.1.3.4CountrySpain
    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 supportH2020
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clínic
    B.5.2Functional name of contact pointPere Ginés
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754001713
    B.5.5Fax number+34932279877
    B.5.6E-mailpgines@clinic.cat
    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 nameRifaximin-EIR
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNRIFAXIMIN
    D.3.9.1CAS number 80621-81-4
    D.3.9.4EV Substance CodeSUB10312MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 Sivastin
    D.2.1.1.2Name of the Marketing Authorisation holderSIGMA-TAU Industrie Farmaceutiche Riunite SpA Viale Shakespeare, 47 – 00144 Roma
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameSivastin
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSIMVASTATIN
    D.3.9.2Current sponsor codeSIVASTIN
    D.3.9.4EV Substance CodeSUB10529MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with decompensated cirrhosis
    Pacientes con cirrosis descompensada
    E.1.1.1Medical condition in easily understood language
    Patients with decompensated cirrhosis
    Pacientes con cirrosis descompensada
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10019641
    E.1.2Term Hepatic cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary 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 evaluate the treatment-related toxicity of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis.
    Evaluar la toxicidad relacionada con el tratamiento de la administración oral de simvastatina más rifaximina en pacientes con cirrosis descompensada.
    E.2.2Secondary objectives of the trial
    1.To evaluate the appearance of muscle toxicity as defined using a statin-associated myopathy questionnaire.
    2.To evaluate hormone levels: plasma renin concentration, serum aldosterone, plasma norepinephrine and plasma copeptin.
    3. To evaluate systemic inflammatory response by measurement in a large array of plasma cytokine levels during the treatment period.
    4.To evaluate levels of plasma biomarkers (FABP4, CD-163) and urine biomarkers (NGAL, IL-18, MCP-1, osteopontin and albumin) during the treatment period.
    5.To evaluate blood levels of bacterial DNA or bacterial products during the treatment period.
    6.To evaluate genetic polymorphisms of statins membrane transporter OATPB1 in patients developing treatment-related toxicity.
    7.To evaluate the treatment-related serious adverse events during the treatment period.
    1.Evaluar la aparición de toxicidad muscular a través del cuestionario de miopatía relacionado con el uso de estatinas.
    2.Evaluar los niveles de hormonas: concentración de renina, aldosterona, norepinefrina y copeptina.
    3.Evaluar la respuesta inflamatoria sistémica mediante la medición de los niveles plasmáticos de un gran número de citoquinas durante el periodo de tratamiento del estudio.
    4.Evaluar niveles plasmáticos de biomarcadores (FABP4, CD-163) y biomarcadores en orina a (NGAL, IL-18, MCP-1, osteopontina y albúmina) durante el periodo de tratamiento del estudio.
    5.Evaluar los niveles en sangre de DNA bacteriano o productos bacterianos durante el periodo de tratamiento del estudio.
    6.Evaluar el polimorfismo genético del transportador de membrana OATPB1 en pacientes que desarrollen toxicidad relacionada con el tratamiento.
    7.Evaluar los acontecimientos adversos graves relacionados con el tratamiento durante el periodo de tratamiento del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years old.
    2. Cirrhosis defined by standard clinical criteria and ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included. Patients with cirrhosis of autoimmune etiology on treatment with corticosteroids must be on stable corticosteroid dose for ≥3-month period before study inclusion.
    3. Child Pugh B/C patients (from 7 to 12 points).
    4. Women of child-bearing potential must have a negative pregnancy test in urine before the inclusion of the study and agree to use highly effective contraceptive methods (combined oral pill, injectable or implanted contraceptive, intrauterine device / intrauterine hormone-releasing system) during the study.
    1. Edad ≥ 18 años.
    2. Cirrosis definida según criterios clínicos estándar y resultados de ultrasonográficos y/o histología. Puede incluirse cirrosis de cualquier etiología. Los pacientes con cirrosis de etiología autoinmune en tratamiento con corticosteroides deberán estar con dosis estables de corticosteroides por ≥ 3 meses previa inclusión en el estudio.
    3. Pacientes con Child-Pugh B y C (de 7 a 12 puntos).
    4. Las mujeres en edad fértil deben tener una prueba negativa de embarazo en orina antes de la inclusión en el estudio y deben comprometerse a utilizar métodos anticonceptivos altamente eficaces (combinado con píldora oral, anticonceptivo inyectable o implante, dispositivo intrauterino / sistema intrauterino liberador de hormona) durante el estudio.
    E.4Principal exclusion criteria
    1. Patients on treatment with statins or rifaximin one month before study inclusion.
    2. Patients on the waiting list for liver transplantation.
    3. Patients with acute-on-chronic liver failure according to the criteria published by Moreau et al. (see appendix 1)
    4. Serum creatinine ≥2 mg/dL.
    5. Serum bilirubin>5 mg/dL.
    6. INR ≥2.5.
    7. Patients with CK elevation of 50% or more above the upper limit of normal at study inclusion.
    8. Bacterial infection within 15 days before study inclusion.
    9. Gastrointestinal bleeding within 15 days before study inclusion.
    10. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy.
    11. HIV infection.
    12. Hepatocellular carcinoma outside Milan criteria, defined as a single nodule ≤5 cm or a maximum of 3 nodules with none >3 cm.
    13. Patients on antiviral therapy for HCV or those who have received it within the last 6 months.
    14. Patients with previous history of myopathy.
    15. Patients on treatment with potent inhibitors of CYP3A4 enzyme (See section 5.2: Concomitant, nonpermitted and permitted medication)
    16. Patients on treatment with drugs with potential interactions with simvastatin (see section 5.2: Concomitant, nonpermitted and permitted medication)
    17. Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
    18. Patients with current extrahepatic malignancies including solid tumours and hematologic disorders.
    19. Patients with previous history or increased risk of intestinal obstruction.
    20. Pregnancy or breastfeeding.
    21. Patients included in other clinical trials in the previous month.
    22. Patients with active alcohol consumption of more than 3 units per day.
    23. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
    24. Severe alcoholic hepatitis requiring corticosteroid therapy (Maddrey’s Discriminant function ≥ 32 and/or ABIC score > 6.7).
    25. Refusal to give informed consent.
    26. Patients with contraindications for statins or rifaximin.
    27. Known hypersensitivity to rifaxamin (or rifamycin derivatives) or to simvastatin.
    1. Pacientes en tratamiento con estatinas o rifaximina durante el mes antes de la inclusión en el estudio.
    2. Pacientes en lista de espera de trasplante hepático.
    3. Pacientes con el síndrome de “acute-on-chronic liver failure” de acuerdo con los criterios de Moreau et al (ver apéndice 1).
    4. Creatinina sérica ≥ 2 mg/dL.
    5. Bilirrubina sérica > 5 mg/dL.
    6. INR ≥ 2,5.
    7. Pacientes con aumento de los niveles de CK del 50% o superiores del límite alto de la normalidad en el momento de la inclusión en el estudio.
    8. Infección bacteriana en los 15 días previos a la inclusión.
    9. Hemorragia gastrointestinal en los 15 días previos a la inclusión.
    10. Encefalopatía hepática clínica en el momento de la inclusión, definida como grado II a IV.
    11. Infección por VIH.
    12. Carcinoma hepatocelular fuera de los criterios de Milán, definido como un nódulo único ≥ 5 cm o un máximo de 3 nódulos de los que ninguno sea > 3 cm.
    13. Pacientes en tratamiento antiviral para el VHC o que lo hayan recibido en los últimos 6 meses.
    14. Pacientes con antecedentes de miopatía.
    15. Pacientes que reciban tratamiento con inhibidores potentes de la enzima CYP3A4 (ver sección 5.2: Medicación concomitante no permitida y permitida).
    16. Pacientes que reciban tratamiento con fármacos con interacciones potenciales con la simvastatina (ver sección 5.2: Medicación concomitante no permitida y permitida).
    17. Pacientes con historia de enfermedad extrahepática significativa con mal pronóstico a corto plazo, incluyendo insuficiencia cardiaca congestiva grado III/IV de la clasificación de New York Heart Association, enfermedad pulmonar obstructiva crónica GOLD >2, enfermedad renal crónica con creatinina sérica > 2 mg/dL o en tratamiento con hemodiálisis.
    18. Pacientes con cáncer actual extrahepático, incluyendo tumores sólidos o enfermedades hematológicas.
    19. Pacientes con antecedente o con riesgo aumentado de obstrucción intestinal.
    20. Embarazo o lactancia.
    21. Pacientes incluidos en otros ensayos clínicos en el último mes.
    22. Pacientes con consumo activo de alcohol de más de 3 unidades de bebida al dia.
    23. Pacientes con incapacidad mental, barrera lingüística mayor, pobre soporte social o alguna otra razón que el investigador considere que no permita una adecuada comprensión, cooperación o seguimiento del estudio.
    24. Hepatitis alcohólica severa que requiera tratamiento con corticoides (función discriminante de Maddrey ≥ 32 y/o score ABIC > 6,7).
    25. Ausencia de consentimiento informado.
    26. Pacientes con contraindicaciones para la rifaximina o la simvastatina.
    27. Hipersensibilidad conocida a la rifaximina (o derivados de la rifamicina) o a la simvastatina.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in transaminases, alkaline phosphatase and creatine kinase during the treatment period, to evaluate treatment-related toxicity.
    This quantitative analysis will be complemented by qualitative binary assessment which will consist of:
    (1) liver toxicity assessed by the development of liver injury defined as 3-fold increase in serum transaminases to a final value at least 3 times the upper normal limit, or 2-fold increase in serum levels of alkaline phosphatase with respect to baseline value to a final value at least 2 times the upper normal limit, or
    (2) muscle toxicity, defined as 5-fold increase in creatinine kinase (CK) levels during treatment.
    Cambios desde la visita basal en la toxicidad relacionada con el tratamiento en transaminasas, fosfatasa alcalina y creatina quinasa a las 12 semanas.
    Este análisis cuantitativo se complementará con una evaluación cualitativa binaria que consistirá en:
    (1) toxicidad hepática evaluada a través del desarrollo de daño hepático definido como un incremento 3 veces por encima de los niveles de transaminasas en suero con respecto al valor basal, a un valor al menos 3 veces superior al límite superior de normalidad o un incremento 2 veces por encima de los niveles de fosfatasa alcalina en suero con respecto al valor basal, a un valor al menos 2 veces superior al límite superior de normalidad, o (2) incremento 5 veces por encima de los niveles de creatinina quinasa (CK) con respecto al valor basal durante el tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    1. Appearance of muscle toxicity at weeks 2, 4, 6, 8, 10 and 12 as defined using a specific statin-associated myopathy questionnaire (see appendix 2).
    2. Changes from baseline in plasma renin concentration, serum aldosterone, plasma norepinephrine, and plasma copeptin levels at weeks 2, 4, 8 and 12.
    3. Changes from baseline in a large array of plasma cytokine levels including, but not limited to, VCAM-1, VEGF-A, Fractalkine, MIP-1α, Eotaxin, IP-10, RANTES, GM-CSF, IL-1β, IL-2, ICAM-1, MCP-1, L-6, and IL-8, as well as an oxidized form of albumin, human nonmercaptalbumin-2 (HNA2) at weeks 2, 4, 8 and 12.
    4. Changes from baseline in plasma biomarkers FABP4 and CD-163 and urine biomarkers NGAL, IL-18, MCP-1, osteopontin, and albumin at weeks 2, 4, 8 and 12.
    5. Changes in blood levels of bacterial DNA or bacterial products at weeks 2, 4, 8 and 12.
    6. Assessment of genetic polymorphisms of statins membrane transporter OATPB1 in patients developing treatment-related toxicity (defined as the primary endpoint of the study).
    7. Proportion of patients with treatment-related serious adverse events during the study period.
    1. Aparición de toxicidad muscular en las semanas 2, 4, 6, 8, 10 y 12 a través del cuestionario de miopatía relacionado con el uso de estatinas.
    2. Cambios desde la basal en los niveles de renina en plasma, aldosterona en suero, norepinefrina en suero y copeptina en plasma en las semanas 2, 4, 8 y 12.
    3. Cambios desde la basal en los niveles plasmáticos de citoquinas incluidos, pero no limitados a VCAM-1, VEGF-A, Fractalquina, MIP-1α, Eotaxina, IP-10, RANTES, GM-CSF, IL-1β, IL-2, ICAM-1, MCP-1, IL-6 and IL-8, así como la forma oxidada de albúmina y no mercaptoalbúmina humana 2 (HNA2) en las semanas 2, 4, 8 y 12.
    4. Cambios desde la basal en biomarcadores plasmáticos FABP4 y CD-163 y biomarcadores en orina NGAL, IL-18, MCP-1, osteopontina y albúmina en las semanas 2, 4, 8 and 12.
    5. Cambios desde la basal en los niveles en sangre de DNA bacteriano o productos bacterianos en las semanas 2, 4, 8 and 12.
    6. Evaluación del polimorfismo genético del transportador de membrana de estatina OATPB1 en pacientes que desarrollan toxicidad relacionada con el tratamiento (definido como la variable principal del estudio).
    7. Proporción de pacientes con acontecimientos adversos graves relacionados con el tratamiento durante todo el periodo de tratamiento del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    weeks 2, 4, 6, 7, 10 and 12
    semanas 2, 4, 6, 7, 10 y 12
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    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 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
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    Expected normal treatment
    Tratamiento clínico habitual
    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 Decision2017-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-12
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA