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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2013-000563-81
    Sponsor's Protocol Code Number:EME
    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:2013-06-26
    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 number2013-000563-81
    A.3Full title of the trial
    Metformin treatment of minimal hepatic encephalopathy in patients with liver cirrhosis
    Tratamiento con metformina de la encefalopatía hepática mínima en pacientes con cirrosis hepática
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Metformin treatment of minimal hepatic encephalopathy in patients with liver cirrhosis
    Tratamiento con metformina de la encefalopatía hepática mínima en pacientes con cirrosis hepática
    A.3.2Name or abbreviated title of the trial where available
    EME
    EME
    A.4.1Sponsor's protocol code numberEME
    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 SponsorFUNDACION PUBLICA ANDALUZA PARA LA GESTION DE LA INVESTIGACION EN SALUD DE SEVILLA
    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 supportFUNDACION PUBLICA ANDALUZA PARA LA GESTION DE LA INVESTIGACION EN SALUD DE SEVILLA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGRUPO DE INVESTIGACION DEL DOCTOR ROMERO
    B.5.2Functional name of contact pointUNIDAD MEDICO QUIRURGICA DE ENFERME
    B.5.3 Address:
    B.5.3.1Street AddressAVDA DE BELLAVISTA
    B.5.3.2Town/ citySEVILLA
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number955015870
    B.5.5Fax number955015799
    B.5.6E-mailsara.mascort.exts@juntadeandalucia.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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 nameMETFORMIN
    D.3.2Product code HCL
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule
    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
    minimal hepatic encephalopathy in patients with liver cirrhosis
    encefalopatía hepática mínima en pacientes con cirrosis hepática
    E.1.1.1Medical condition in easily understood language
    minimal hepatic encephalopathy in patients with liver cirrhosis
    encefalopatía hepática mínima en pacientes con cirrosis hepática
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10014630
    E.1.2Term Encephalopathy hepatic
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effect of decreasing insulin resistance by administration of metformin in the treatment of minimal hepatic encephalopathy in patients with liver cirrhosis.
    Evaluar el efecto de la disminución de la resistencia a la insulina, mediante la administración de metformina, en el tratamiento de encefalopatía hepática mínima, en pacientes con cirrosis hepática.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and safety of treatment with metformin in patients with liver cirrhosis.
    Evaluar la eficacia y seguridad del tratamiento con metformina en pacientes con cirrosis hepática.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men and women aged 18 years. Diagnosis of EHM, introducing at least one of the following alterations:
    PHES <4.
    FCP <39 Hz Diagnosis of liver cirrhosis by imaging techniques (ultrasound, CT computeriazada, MRI) or liver biopsy (Metavir classification F4). In women of childbearing potential, negative pregnancy test. Effective contraceptive measures during treatment and for 6 months after treatment ends.
    Hombres y mujeres 18 años de edad. Diagnóstico de EHM, tras presentar, al menos, una de las siguientes alteraciones:
    PHES < 4.
    FCP < 39 Hz. Diagnóstico de cirrosis hepática por técnicas de imagen (ecografía, tomografía computeriazada, resonancia magnética) o por biopsia hepática (F4 en clasificación Metavir). En mujeres en edad fértil, prueba de embarazo negativa. Medidas contraceptivas eficaces durante el tratamiento y durante 6 meses después de finalizar el tratamiento.
    E.4Principal exclusion criteria
    Patients who have experienced an episode of hepatic encephalopathy before the start of the study. Patients with type 1 diabetes mellitus. Patients with type 2 diabetes mellitus treated with insulin, metformin or any other oral antidiabetic. Patients treated with benzodiazepines. Pregnant or breastfeeding. Systemic antineoplastic treatment or immunomodulators (including steroids and supraphysiological doses of radiation) 6 months prior to the first dose of treatment. Treatment with any investigational drug within 6 weeks prior to the first dose of treatment. Signs or symptoms of hepatocellular carcinoma. Background or other evidence of bleeding from esophageal varices. Neutrophil count <1500 cells/mm3 or a platelet count <90,000 cells/mm3 at the time of screening. Hgb <10 at the time of evaluation. Patients with documented or suspected coronary artery disease or cerebrovascular disease should not be treated if in the judgment of the investigator, could see their conditions worsened during the study. Serum creatinine> 1.5 times the upper limit of normal at the time of evaluation. History of severe psychiatric illness, particularly depression. It is defined as a severe psychiatric disorder that requires treatment with antidepressants or major tranquillizers in therapeutic doses required for major depression or psychosis, respectively, for at least three months at any time before or any of the following background: attempted suicide, hospitalization for of psychiatric illness, or disability period due to psychiatric illness. Background severe seizure disorder or current use of anticonvulsants. History of autoimmune disease, chronic lung disease associated with limited functionality, serious heart disease, congestive heart failure, advanced arteriosclerosis, increased organ transplant or other indications of serious disease, neoplasia, or any other condition that, in the opinion of the investigator, would prevent the patient is suitable for the study. History of thyroid disease poorly controlled with medications prescribed, elevated thyroid stimulating hormone (TSH) with increased thyroid peroxidase antibodies and any clinical manifestations of thyroid disease. Acute conditions involving a risk of impaired renal function: dehydration (diarrhea, vomiting), fever, infectious conditions and / or severe hypotonic (shock, sepsis, urinary tract infection, neuropathy).
    Radiological examination with intravenous administration of contrast media (IVP, angiography). Evidence of drug use in the six months preceding the survey. Alcohol. Inability or unwillingness to give informed consentiomiento or to meet the requirements of the study.
    Pacientes que hayan presentado un episodio de encefalopatía hepática previo al inicio del estudio. Pacientes con diabetes mellitus tipo 1. Pacientes con diabetes mellitus tipo 2 en tratamiento previo con insulina, con metformina o con cualquier otro antidiabético oral. Pacientes en tratamiento con benzodiacepinas. Mujeres embarazadas o en período de lactancia. Tratamiento con antineoplásicos sistémicos o con inmunomoduladores (incluyendo dosis suprafisiológicas de esteroides y radioterapia) 6 meses antes de la primera dosis del tratamiento. Tratamiento con cualquier fármaco en investigación 6 semanas antes de la primera dosis del tratamiento. Signos o síntomas de carcinoma hepatocelular. Antecedentes u otra evidencia de sangrado a causa de varices esofágicas. Recuento de neutrófilos <1500 células/mm3 o recuento de plaquetas <90,000 células/mm3 en el momento del Screening. Hgb <10, en el momento de la evaluación. Los pacientes con coronariopatía documentada o presuntiva o enfermedad cerebrovascular no deberán ser tratados si, a juicio del investigador, pudiesen ver empeoradas sus patologías durante el estudio. Nivel de creatinina sérica >1.5 veces por encima del límite superior normal en el momento de la evaluación. Antecedentes de enfermedad psiquiátrica grave, en particular depresión. Se define como enfermedad psiquiátrica grave la que requiera tratamiento con antidepresivos o tranquilizantes mayores en dosis terapéuticas requeridas para depresión mayor o psicosis, respectivamente, durante al menos 3 meses en cualquier momento previo o cualquiera de los siguientes antecedentes: intento de suicidio, hospitalización a causa de enfermedad psiquiátrica, o período de discapacidad debido a enfermedad psiquiátrica. Antecedentes de trastorno convulsivo grave o uso actual de anticonvulsivos. Antecedentes de enfermedad inmunológica, enfermedad pulmonar crónica asociada con funcionalidad limitada, cardiopatía grave, insuficiencia cardiaca congestiva, arterioesclerosis avanzada, trasplante mayor de órgano u otros indicios de enfermedad grave, neoplasia, o cualquier otra enfermedad que, a juicio del investigador, impida que el paciente sea apto para el estudio. Antecedentes de enfermedad tiroidea mal controlada con las medicaciones prescritas, concentraciones elevadas de la hormona estimulante del tiroides (TSH) con aumento de anticuerpos a la peroxidasa tiroidea y cualquier manifestación clínica de enfermedad tiroidea. Patología aguda que impliquen riesgos de alteración de la función renal: deshidratación (diarrea, vómitos), fiebre, estados infecciosos y/o hipotónicos graves (choques, septicemia, infección urinaria, neuropatía).
    Exploración radiológica con administración intravenosa de medios de contraste (UIV, angiografía). Evidencia de consumo de drogas en los seis meses previos al estudio. Consumo de alcohol. Incapacidad o reticencia para dar el consentiomiento informado o para cumplir los requerimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Minimal hepatic encephalopathy improvement after reducing insulin resistance in patients treated with metformin.
    Mejoría de encefalopatía hepática mínima tras la reducción de la resistencia a la insulina en pacientes tratados con metformina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    END OF TREATMENT
    FINAL DE TRATAMIENTO
    E.5.2Secondary end point(s)
    Efficacy and safety of treatment with metformin in patients with liver cirrhosis
    Eficacia y seguridad del tratamiento con metformina en pacientes con cirrosis hepática
    E.5.2.1Timepoint(s) of evaluation of this end point
    END OF TREATMENT
    FIN DE TRATAMIENTO
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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
    NVLS
    NVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    NO
    NO
    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 Decision2014-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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