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    Summary
    EudraCT Number:2019-000302-29
    Sponsor's Protocol Code Number:AlbuCAT
    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:2019-04-12
    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 number2019-000302-29
    A.3Full title of the trial
    ALBUMIN FOR MANAGEMENT OF HYPERVOLEMIC HYPONATREMIA IN PATIENTS WITH DECOMPENSATED CIRRHOSIS. A PROOF OF CONCEPT STUDY
    ALBUMINA PARA EL MANEJO DE LA HIPONATREMIA HIPERVOLEMICA EN PACIENTES CON CIRROSIS DESCOMPENSADA. Estudio de concepto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ALBUMIN FOR MANAGEMENT OF HYPERVOLEMIC HYPONATREMIA IN PATIENTS WITH DECOMPENSATED CIRRHOSIS. A PROOF OF CONCEPT STUDY
    ALBUMINA PARA EL MANEJO DE LA HIPONATREMIA HIPERVOLEMICA EN PACIENTES CON CIRROSIS DESCOMPENSADA. Estudio de concepto.
    A.3.2Name or abbreviated title of the trial where available
    AlbuCAT
    AlbuCAT
    A.4.1Sponsor's protocol code numberAlbuCAT
    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 SponsorFundació Clinic per a la Recerca Biomèdica
    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 supportInstituto Grifols S.A
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical trial Unit (CTU)
    B.5.2Functional name of contact pointCTU
    B.5.3 Address:
    B.5.3.1Street AddressRossello 138
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932279838
    B.5.6E-mailacruceta@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 Yes
    D.2.1.1.1Trade name Human Albumin 200 g/l, solution for infusion
    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 nameHuman Albumin
    D.3.4Pharmaceutical form Solution 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 INNHuman serum albumin
    D.3.9.3Other descriptive nameHUMAN SERUM ALBUMIN
    D.3.9.4EV Substance CodeSUB20344
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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
    HYPERVOLEMIC HYPONATREMIA IN PATIENTS WITH DECOMPENSATED CIRRHOSIS
    hiponatremia hipervolémica en pacientes con cirrosis descompensada
    E.1.1.1Medical condition in easily understood language
    hipervolemic hiponatremia in descomensated cirrhosis
    hiponatremia en cirrosis descomensada
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009211
    E.1.2Term Cirrhosis liver
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period
    resolución de hiponatremia, definida como un aumento en el sodio sérico de más de 5 mEq / L con un valor final> 130 mEq / L, mantenido durante al menos 48 horas consecutivas durante el período de tratamiento de 10 días
    E.2.2Secondary objectives of the trial
    1. number of patients that present a partial resolution of hyponatremia, defined as an increase in serum sodium of more than 5meq/L with a final value below 130meq/L, maintained for at least 48 consecutive hours during the 10-day treatment period.
    2. daily measurement of mean arterial pressure and the activity of the Renin-Angiotensin-Aldosterone axis,
    3. creatinine levels, glomerular filtration rate as assessed by MDRD-4 formula and urine volume, and also serum cystatin C levels
    4. PCR and leukocytes levels, PGE2 levels and of a large array of plasma cytokines .
    5. PHES questionnaire and HRQL tests
    6. Magnetic Resonance Spectroscopy (MRS)
    7. performance of hepatic SPECT
    8. (Phagotest and Phagoburst) evaluating
    9. microbiome composition
    10. development of infections, f complications of cirrhosis and survival.
    11. measurement of serum albumin levels
    12. To evaluate treatment-related serious adverse events
    13. albumin, bilirubin an prothrombin
    1. resolución parcial de hiponatremia, definido como un aumento en el sodio sérico de más de 5 meq / l con un valor final por debajo de 130 meq / l, mantenido durante al menos 48 horas consecutivas durante el período de tratamiento de 10 días.
    2. Medición de la presión arterial media y del eje renina-angiotensina-aldosterona.
    3. Los niveles de creatinina, la tasa de filtración glomerular según la fórmula de MDRD-4 y el volumen de orina, ylos niveles séricos de cistatina C
    4. Niveles de PCR y leucocitos, niveles de PGE2 y de una gran variedad de citoquinas plasmáticas.
    5. Cuestionario de PHES y pruebas de CVRS.
    6. Espectroscopia de Resonancia Magnética (MRS)
    7. SPECT hepática.
    8. (Phagotest y Phagoburst)
    9. composición microbioma
    10. Desarrollo de infecciones, complicaciones por cirrosis y supervivencia.
    11. Medición de los niveles de albúmina sérica.
    12. Evaluar eventos adversos graves relacionados con el tratamiento.
    13. albúmina, bilirrubina y protrombi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients included into the study must meet all the following criteria:
    This study will include patients with liver cirrhosis and hypervolemic hyponatremia (serum sodium<130 mEq/L) admitted to hospital for any decompensation of the disease. Patients will be enrolled if hyponatremia persists after 3 days of diuretic withdrawal and fluid restriction.
    Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner.
    Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
    Este estudio incluirá pacientes con cirrosis hepática e hiponatremia hipervolémica (sodio sérico <130 mEq / L) ingresados ​​en el hospital por cualquier descompensación de la enfermedad. Se inscribirá a los pacientes si la hiponatremia persiste después de 3 días de abstinencia diurética y restricción de líquidos.
    Las mujeres en edad fértil deben tener una prueba de embarazo negativa en suero antes de la inclusión en el estudio y aceptar el uso de métodos anticonceptivos altamente efectivos, como dispositivos intrauterinos, oclusión tubárica bilateral o un compañero vasectomizado.
    Se evitarán los métodos anticonceptivos hormonales debido al riesgo de eventos adversos y al deterioro de la función hepática.
    E.4Principal exclusion criteria
    1) Patients with Acute kidney injury 1B or higher;
    2) Chronic kidney disease grade 3a or higher, defined as glomerular filtration rate <60ml/min for three months and markers of kidney damage (one or more): Albuminuria (Albumin excretion rate > 30 mg/24h; Albumin-to-creatinine ratio > 30 mg/g), Urine sediment abnormalities, Electrolyte and other abnormalities due to tubular disorders, Electrolyte and other abnormalities due to tubular disorders, Abnormalities detected by histology or Structural abnormalities detected by imaging.
    3) Previous kidney or liver transplant;
    4) Active infection apart from spontaneous bacterial peritonytis based on positive culture (blood, urine, sputum or other samples) or by the following criteria:
    (a) Urinary infections: signs of systemic inflammation and more than 10 leukocytes per high-power field in urine;
    (b) Pneumonia: compatible symptoms (cough, purulent sputum, chest pain, shortness of breath) and presence of new infiltrates on chest x-ray;
    (c) Skin/soft tissue infection: physical exam findings of swelling, erythema, heat and tenderness in the skin;
    (d) Acute cholangitis: signs of systemic inflammation1, compatible symptoms (right upper quadrant pain and jaundice) and radiological data of biliary obstruction, analytical data of cholestasis;
    (e) Suspected bacterial infection: signs of systemic inflammation1 but no identifiable origin of this infection (polymorphonuclear cells in ascitic and pleural fluid < 250/mm3, normal urine sediment and chest X-ray)
    After 48 hours of appropriate antibiotic treatment patients can be enrolled.
    5) Spontaneous bacterial peritonitis.
    6) Hypo or hyperthyroidism not controlled under adequate treatment.
    7) Associated heart failure, defined as a New York Heart Association (NYHA) classification III or IV or heart failure with reduced ejection fraction (LVEF<40%). Previously known structural cardiomyopathy including ischemic cardiomyopathy, restrictive cardiomyopathy or valvular cardiomyopathy.
    8) Hepatocellular carcinoma beyond Milan criteria.
    9) Severe alcoholic hepatitis defined by Maddrey score ≥32 and/or MELD score ≥ 20
    10) ACLF with two or more organ failures
    11) Treatment with diuretics (furosemide or spironolactone), albumin infusion, somatostatin or terlipresin in the previous 3 days.
    12) Symptomatic hyponatremia (manifested by cardio-respiratory distress, abnormal and deep somnolence, seizures or coma) with serum sodium below 120 mEq/L.
    13) Previous known hypersensitivity to human albumin
    14) Refuse to give informed consent
    1) Pacientes con lesión renal aguda 1B o superior;
    2) Enfermedad renal crónica de grado 3a o superior, definida como tasa de filtración glomerular <60 ml / min durante tres meses y marcadores de daño renal (uno o más): albuminuria (tasa de excreción de albúmina> 30 mg / 24h; relación albúmina-creatinina > 30 mg / g), anomalías en los sedimentos de orina, electrolitos y otras anomalías debidas a trastornos tubulares, electrolitos y otras anomalías debidas a trastornos tubulares, anomalías detectadas por histología o anomalías estructurales detectadas mediante imágenes.
    3) Trasplante renal o hepático previo;
    4) Infección activa aparte de peritonitis bacteriana espontánea basada en cultivo positivo (sangre, orina, esputo u otras muestras) o según los siguientes criterios:
    (a) Infecciones urinarias: signos de inflamación sistémica y más de 10 leucocitos por campo de alto poder en la orina;
    (b) Neumonía: síntomas compatibles (tos, esputo purulento, dolor en el pecho, dificultad para respirar) y presencia de nuevos infiltrados en la radiografía de tórax;
    (c) Infección de la piel / tejidos blandos: hallazgos en el examen físico de hinchazón, eritema, calor y sensibilidad en la piel;
    (d) Colangitis aguda: signos de inflamación sistémica1, síntomas compatibles (dolor en el cuadrante superior derecho e ictericia) y datos radiológicos de obstrucción biliar, datos analíticos de colestasis;
    (e) Sospecha de infección bacteriana: signos de inflamación sistémica1 pero ningún origen identificable de esta infección (células polimorfonucleares en líquido ascítico y pleural <250 / mm3, sedimento urinario normal y radiografía de tórax)
    Después de 48 horas de tratamiento antibiótico apropiado, los pacientes pueden ser incluidos.
    5) Peritonitis bacteriana espontánea.
    6) Hipo o hipertiroidismo no controlado bajo tratamiento adecuado.
    7) Insuficiencia cardíaca asociada, definida como clasificación III o IV de la New York Heart Association (NYHA) o insuficiencia cardíaca con fracción de eyección reducida (FEVI <40%). Cardiomiopatía estructural previamente conocida, que incluye cardiomiopatía isquémica, miocardiopatía restrictiva o miocardiopatía valvular.
    8) Carcinoma hepatocelular más allá de los criterios de Milán.
    9) hepatitis alcohólica grave definida por la puntuación de Maddrey ≥32 y / o la puntuación MELD ≥ 20
    10) ACLF con dos o más fallas de órganos
    11) Tratamiento con diuréticos (furosemida o espironolactona), infusión de albúmina, somatostatina o terlipresina en los 3 días anteriores.
    12) Hiponatremia sintomática (manifestada por insuficiencia cardiorrespiratoria, somnolencia anormal y profunda, convulsiones o coma) con sodio sérico por debajo de 120 mEq / L.
    13) Hipersensibilidad conocida anterior a la albúmina humana.
    14) Negarse a dar consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    Resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L maintained for at least 48 consecutive hours during the 10-day treatment period. Treatment with albumin will be stopped whenever the endpoint is reached or after 10 days.
    La resolución de la hiponatremia, definida como un aumento en el sodio sérico de más de 5 mEq / L con un valor final> 130 mEq / L mantenido durante al menos 48 horas consecutivas durante el período de tratamiento de 10 días. El tratamiento con albúmina se detendrá cuando se alcance el punto final o después de 10 días.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Evaluation of the number of patients that present a partial resolution of hyponatremia, defined as an increase in serum sodium of more than 5meq/L with a final value below 130meq/L, maintained for at least 48 consecutive hours during the 10-day treatment period.
    1. Evaluación del número de pacientes que presentan una resolución parcial de hiponatremia, definida como un aumento de sodio sérico de más de 5 meq / l con un valor final por debajo de 130 meq / l, mantenido durante al menos 48 horas consecutivas durante los 10 días del tratamiento.
    E.5.2Secondary end point(s)
    1. Evaluation of the number of patients that present a partial resolution of hyponatremia, defined as an increase in serum sodium of more than 5meq/L with a final value below 130meq/L, maintained for at least 48 consecutive hours during the 10-day treatment period.
    2. Evaluation of systemic hemodynamics by daily measurement of mean arterial pressure and also by evaluation of the activity of the Renin-Angiotensin-Aldosterone axis, by measurement of plasma copeptin, plasma aldosterone, plasma renin and plasma norepinephrine concentration and urine sodium and urine cAMP levels at at day 0, at day 5 and at day 10 (or at the end of study in case of early termination) of the study period.
    3. Evaluation of serum sodium levels and kidney function along the study period, by daily measurement of creatinine levels, glomerular filtration rate as assessed by MDRD-4 formula and urine volume, and also by measurement of serum cystatin C levels at day 0, 5 and 10 (or at the end of study in case of early termination).
    4. Effects on the inflammatory profile will be assessed by evaluation of PCR and leukocytes levels, PGE2 levels and of a large array of plasma cytokines by using a multiplex kit including plasmatic cytokines related to immune response. This multiplex test will be performed at day 0 and day 10 of the study period (or at the end of study in case of early termination).
    5. Effects on neurocognitive function and quality and will be assessed by: PHES questionnaire and HRQL tests will be performed at day 0 and day 10 of the study period (or at the end of study in case of early termination).
    6. Effects on brain water content will be evaluated by performance of a Magnetic Resonance Spectroscopy (MRS) at day 0 and at day 10 of the study period (or at the end of study in case of early termination).
    7. Effects of albumin administration on liver phagocytic capacity as assessed by performance of hepatic SPECT with 99mTc-phytate at day 0 and 10 (or at the end of study in case of early termination).
    8. Effects on phagocytic capacity and inflammatory response of peripheral monocytes will be assessed by performance specific tests (Phagotest and Phagoburst) evaluating the in vitro phagocytic capacity and burst response. Monocytes will be isolated and analysed at day 0 and at day 10 of the study period (or at the end of study in case of early termination).
    9. Effects of albumin administration of microbiome composition as assessed by analysis of microbiome composition at day 0 and 10 of the study period (or at the end of study in case of early termination).
    10. Effects of albumin administration on development of infections, development of complications of cirrhosis and survival.
    11. Effects of albumin administration on serum albumin levels as assessed by measurement of serum albumin levels at day 0, 5, 10, 28 and 90 of study period.
    12. To evaluate treatment-related serious adverse events during the treatment period (visit day 1,2,3,4,5,6,7,8,9,28 and 90).
    13. To evaluate liver function assessed by albumin, bilirubin an prothrombin time ad days 0 and 10(or at the end of study in case of early termination).
    1. Evaluación del número de pacientes que presentan una resolución parcial de hiponatremia, definida como un aumento de sodio sérico de más de 5 meq / l con un valor final por debajo de 130 meq / l, mantenido durante al menos 48 horas consecutivas durante los 10 días Período de tratamiento.
    2. Evaluación de la hemodinámica sistémica mediante la medición diaria de la presión arterial media y también mediante la evaluación de la actividad del eje Renina-Angiotensina-Aldosterona, mediante la medición de la copeptina plasmática, la aldosterona plasmática, la renina plasmática y la concentración plasmática de norepinefrina y la orina de sodio y cAMP. niveles en el día 0, en el día 5 y en el día 10 (o al final del estudio en caso de finalización anticipada) del período de estudio.
    3. Evaluación de los niveles séricos de sodio y la función renal a lo largo del período de estudio, mediante la medición diaria de los niveles de creatinina, la tasa de filtración glomerular según la fórmula MDRD-4 y el volumen de orina, y también la medición de los niveles séricos de cistatina C en el día 0, 5 y 10 (o al final del estudio en caso de terminación anticipada).
    4. Los efectos sobre el perfil inflamatorio se evaluarán mediante la evaluación de los niveles de PCR y leucocitos, los niveles de PGE2 y una gran variedad de citoquinas plasmáticas mediante el uso de un kit multiplex que incluye citoquinas plasmáticas relacionadas con la respuesta inmune. Esta prueba múltiple se realizará el día 0 y el día 10 del período de estudio (o al final del estudio en caso de finalización anticipada).
    5. Los efectos sobre la función y la calidad neurocognitiva se evaluarán mediante: El cuestionario PHES y las pruebas de la CVRS se realizarán el día 0 y el día 10 del período de estudio (o al final del estudio en caso de terminación anticipada).
    6. Los efectos sobre el contenido de agua en el cerebro se evaluarán mediante la realización de una Espectroscopia de Resonancia Magnética (MRS) el día 0 y el día 10 del período de estudio (o al final del estudio en caso de terminación anticipada).
    7. Efectos de la administración de albúmina sobre la capacidad fagocítica hepática según lo evaluado por el rendimiento de SPECT hepático con 99mTc-fitato en los días 0 y 10 (o al final del estudio en caso de finalización temprana).
    8. Los efectos sobre la capacidad fagocítica y la respuesta inflamatoria de los monocitos periféricos se evaluarán mediante pruebas específicas de rendimiento (Phagotest y Phagoburst) que evalúan la capacidad fagocítica in vitro y la respuesta al estallido. Los monocitos se aislarán y analizarán el día 0 y el día 10 del período de estudio (o al final del estudio en caso de terminación anticipada).
    9. Efectos de la administración de albúmina de la composición del microbioma según se evaluó mediante el análisis de la composición del microbioma en los días 0 y 10 del período de estudio (o al final del estudio en caso de terminación anticipada).
    10. Efectos de la administración de albúmina en el desarrollo de infecciones, desarrollo de complicaciones de la cirrosis y supervivencia.
    11. Efectos de la administración de albúmina en los niveles de albúmina sérica según lo determinado por la medición de los niveles de albúmina sérica en los días 0, 5, 10, 28 y 90 del período de estudio.
    12. Evaluar los eventos adversos graves relacionados con el tratamiento durante el período de tratamiento (día de la visita 1,2,3,4,5,6,7,8,9,28 y 90).
    13. Para evaluar la función hepática evaluada por albúmina, bilirrubina y tiempo de protrombina hasta los días 0 y 10 (o al final del estudio en caso de finalización temprana).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.maintained for at least 48 consecutive hours during the 10-day treatment period.
    2.levels at at day 0, at day 5 and at day 10 (or at the end of study in case of early termination) of the study period.
    3. levels at day 0, 5 and 10 (or at the end of study in case of early termination).
    4 ,5, 6, 7 ,8 and 9.levels at day 0, and 10 (or at the end of study in case of early termination).
    10. Effects of albumin administration on development of infections, development of complications of cirrhosis and survival.
    11. levels at day 0, 5, 10, 28 and 90 of study period.
    12.(visit day 1,2,3,4,5,6,7,8,9,28 and 90).
    13. days 0 and 10(or at the end of study in case of early termination).
    1. durante al menos 48 horas consecutivas durante el período de tratamiento de 10 días.
    2. niveles en el día 0, el día 5 y el día 10 (o al final del estudio en caso de finalización anticipada) del período de estudio.
    3. niveles en los días 0, 5 y 10 (o al final del estudio en caso de finalización anticipada).
    4, 5, 6, 7, 8 y 9. niveles en los días 0 y 10 (o al final del estudio en caso de finalización anticipada).
    10. Efectos de la administración de albúmina en el desarrollo de infecciones, desarrollo de complicaciones de la cirrosis y supervivencia.
    11. niveles en los días 0, 5, 10, 28 y 90 del período de estudio.
    12. (visita el día 1,2,3,4,5,6,7,8,9,28 y 90).
    13. días 0 y 10 (o al final del estudio en caso de finalización anticipada)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States 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
    LVLS
    LVLS
    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 days0
    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 days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 52
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state52
    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)
    none
    ninguno
    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 Decision2019-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-31
    P. End of Trial
    P.End of Trial StatusOngoing
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