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    Summary
    EudraCT Number:2013-002416-27
    Sponsor's Protocol Code Number:INFECIR2
    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:2013-09-16
    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 number2013-002416-27
    A.3Full title of the trial
    Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.
    Efecto de la administración de albúmina en la prevención del síndrome hepatorrenal (SHR) y mortalidad de pacientes con cirrosis, infecciones bacterianas diferentes de peritonitis bacteriana espontánea (PBE) y alto riesgo de mortalidad hospitalaria.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.
    Efecto de la administración de albúmina en la prevención del síndrome hepatorrenal (SHR) y mortalidad de pacientes con cirrosis, infecciones bacterianas diferentes de peritonitis bacteriana espontánea (PBE) y alto riesgo de mortalidad hospitalaria.
    A.3.2Name or abbreviated title of the trial where available
    The INFECIR-2 Albumin Prevention Study
    INFECIR 2 estudio de prevención con infusión de albumina
    A.4.1Sponsor's protocol code numberINFECIR2
    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 SponsorFundacio Clinic per a la recerca biomedica
    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 supportFundacio Clinic per a la recerca biomedica
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundacio Clinic per a la recerca biomedica
    B.5.2Functional name of contact pointFundacio Clinic
    B.5.3 Address:
    B.5.3.1Street AddressCalle Mallorca 183
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number00349322718261826
    B.5.6E-mailrigarcia@clinic.ub.es
    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
    D.2.1.1.2Name of the Marketing Authorisation holdergrifols
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Patients with advanced cirrhosis (serum creatinine ? 1.2 mg/dl, serum sodium ? 130 mEq/l and/or serum bilirubin ?4 mg/dl), signs of systemic inflammation and urinary infection, pneumonia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will be included
    Se incluiran pacientes con cirrosis avanzada (creatinina ? 1.2 mg/dl, sodio ?130 mEq/l y/o bilirrubina ?4 mg/dl), signos de inflamacion sistemica e infeccion urinaria, neumonia, infeccion de piel y partes blandas, colangitis aguda o sospecha de infeccion bacteriana
    E.1.1.1Medical condition in easily understood language
    Patients with advanced cirrhosis, signs of systemic inflammation and urinary infection, pneumonia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will be included
    Se incluiran pacientes con cirrosis avanzada , signos de inflamacion sistemica e infeccion urinaria, neumonia, infeccion de piel y partes blandas, colangitis aguda o sospecha de infeccion bacteriana
    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 10024667
    E.1.2Term Liver cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10008954
    E.1.2Term Chronic liver disease and cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10019641
    E.1.2Term Hepatic cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10064704
    E.1.2Term Decompensated cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10009213
    E.1.2Term Cirrhosis of liver
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10009211
    E.1.2Term Cirrhosis liver
    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
    In hospital and 28-day mortality reduction in patients with advance cirrhosis, infection other than spontaneous bacterial peritonitis and high risk mortality
    Reduccion de la mortalidad hospitalaria y a los 28 dias en pacientes con cirrhosis avanzada, infecciones diferentes de la peritonitis bacteriana espontanea y elevado riesgo de muerte.
    E.2.2Secondary objectives of the trial
    ? 90-day survival
    ? Incidence of renal dysfunction during hospitalization
    ? Incidence of type-1 and type-2 HRS during hospitalization
    ? Changes in plasma levels of renin and noradrenaline and in serum lactate levels during treatment of infection in both treatment arms
    ? Changes in serum levels of IL-6, TNF-alpha and NOX and in plasma levels of vWF:Ag in both treatment arms
    ? Changes in blood leukocyte count and serum CRP levels during treatment of infection in both treatment arms
    ? Changes in CLIF-SOFA, CLIF-Consortium, CHILD-PUGH and MELD scores in both treatment arms
    ? Incidence of new individual organ failures during hospitalization in both treatment arms
    ? Incidence of ACLF (type 1, 2 and 3 according to the Canonic Study) during hospitalization in both treatment arms
    ? Risk factors of HRS and ACLF in both treatment arms
    ? Risk factors of short-term mortality in both treatment arms
    ? Causes of death in both treatment arms
    ? Length of hospital stay
    ? Mortalidad a los 90 días
    ? Disfunción renal y síndrome hepatorrenal durante la hospitalización
    ? Cambios en los niveles plasmáticos de renina, noradrenalina y lactato durante el tratamiento de la infección.
    ? Cambios en los niveles plasmáticos de IL6, TNF, óxido nítrico y von Willebrand factor.
    ? Cambio en los niveles plasmáticos de la proteína C reactiva y leucocitos
    ? Cambios en los score pronósticos: CLIF-SOFA, CLIF-consortium, CHILD-PUGH, MELD
    ? Incidencia de un nuevo fallo de órgano durante la hospitalización
    ? Incidencia de Acute-on-Chronicliverfailure (ACLF) y sus subtipos durante la hospitalización
    ? Factores de riesgo de SHR, ACLF y mortalidad a corto plazo
    ? Estancia hospitalaria (longitud)
    ? Causas de muerte.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age between 18 and 79 years.
    - Diagnosis of liver cirrhosis established by histology or by the combination of clinical, analytical and ultrasonographic data.
    - Clinical data of systemic inflammation indicated by the presence of at least 1 diagnostic criterion of SIRS and high serum CRP levels (? 2 mg/dL or 20 mg/L).
    - Diagnosis of urinary infection, pneumonia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection at hospital admission or during hospitalization. Diagnostic criteria at inclusion will be the following: (a) urinary infections: more than 10 leukocytes per high-power field in urine or a positive reagent strip; (b) pneumonia: 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: cholestasis, compatible symptoms (right upper quadrant pain and jaundice) and radiological data of biliary obstruction and (e) suspected bacterial infection: signs of infection but no identifiable origin of this infection (polymorphonuclear cells in ascitic and pleural fluid < 250/mm3, normal urine sediment and chest X-ray).
    - Presence of renal and/or liver dysfunction (serum creatinine ?1.2 mg/dl, serum bilirubin ?4 mg/dl or serum sodium ? 130 mEq/l). Patients with pneumonia will require the presence of at least 1 of these analytical criteria to be included in the study. Two or more criteria will be required in patients with urinary infection, skin/soft tissue infection, acute cholangitis or suspected bacterial infection.
    ? Pacientes cirróticos entre 18 y 79 años
    ? > 1 Signo de respuesta inflamatoria sistémica.
    ? Proteína C reactiva > 2 mg/dl (marcador de infección bacteriana en cirrosis)
    ? Neumonía, infección urinaria, infección de piel/partes blandas, colangitis o sospecha de infección bacteriana
    ? Datos analíticos de insuficiencia hepática/renal (creatinina > 1.2 mg/dl, bilirrubina > 4 mg/dl, sodio < 130 mEq/L). Al menos un parámetro en pacientes con neumonía, y al menos 2 para el resto de infecciones son requeridos para participar en el estudio
    E.4Principal exclusion criteria
    - > 48h after the diagnosis of infection.
    - Pregnancy.
    - Acute or subacute liver failure without underlying cirrhosis.
    - Septic shock (mean arterial pressure below 60 mmHg during more than 1 hour despite adequate fluid resuscitation and need of vasopressor drugs).
    - Acute respiratory distress syndrome [PaO2/Fi02 ?200 or a pulse oximetric saturation (SpO2) to FiO2 ratio ?214].
    - Gastrointestinal bleeding in the last 5 days.
    - Biopsy proven severe acute alcoholic hepatitis requiring specific treatment.
    - Type-1 HRS (IAC criteria: serum creatinine ? 2.5 mg/dl).
    - Type-3 ACLF.
    - Intrinsic nephropathy (proteinuria, hematuria or abnormal findings on renal ultrasonography) with renal failure (serum creatinine chronically ? 1.5 mg/dl).
    - Renal replacement therapy.
    - Arterial hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg).
    - Evidence of current malignancy (except for hepatocellular carcinoma within Milan criteria or non-melanocytic skin cancer),
    - Moderate or severe chronic heart (NYHA class II, III or IV).
    - Severe pulmonary disease (GOLD III or IV).
    - Severe psychiatric disorders.
    - Any immunosuppressive drug.
    - HIV infection.
    - Contraindications to albumin (allergy, signs of pulmonary edema)
    - Administration of any dose of IV albumin in the last 10 days
    - Clinical indication for albumin use at inclusion (spontaneous bacterial peritonitis coinfection, large volume paracentesis)
    - Refusal to participate.
    - Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
    - Physician and team not committed to intensive care if needed.
    ? > 48 horas desde el diagnóstico de la infección
    ? Embarazo
    ? Insuficiencia hepática aguda/subaguda sin cirrosis previa
    ? Shock séptico
    ? Síndrome de distress respiratorio agudo
    ? Hemorragia digestiva en los últimos 5 días
    ? Hepatitis aguda alcohólica grave demostrada por biopsia que requiere tratamiento especifico
    ? ACLF tipo 3
    ? SHR tipo 1
    ? Nefropatía intrínseca (creatinina > 1.5 mg/dl crónicamente).
    ? Hemodiálisis u otra diálisis renal
    ? Hipertensión arterial (TAS > 160 mmHg y/o TAD > 90mmHg)
    ? Neoplasia maligna (excepto hepatocarcinoma dentro de los criterios de Milán o tumor de piel no melanocitico).
    ? Insuficiencia cardiaca crónica moderada o severa (clases II, III o IV de la NYHA) o enfermedad pulmonar crónica moderada o severa (GOLD III o IV).
    ? Trastorno psiquiátrico grave
    ? Tratamiento inmunosupresor
    ? Infección por el virus de la inmunodeficiencia humana (VIH)
    ? Administración de albumina en los últimos 10 días
    ? Indicación clínica para albumina en el momento de la inclusión (paracentesis de alto volumen, PBE)
    ? Contraindicación para recibir albumina (alergia, congestión pulmonar).
    ? Negativa del paciente a participar
    ? Imposibilidad de obtener consentimiento informado, y cuando existe evidencia documental de que el paciente dará su consentimiento de forma diferida.
    ? Imposibilidad para garantizar tratamiento intensivo si se necesita.
    E.5 End points
    E.5.1Primary end point(s)
    ? To evaluate the effect of albumin administration on hospital and 28-day survival
    ? Evaluar el efecto de la albumina en la mortalidad hospitalaria y a los 28 días
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 3, day of infection resolution (or day 7 and every 7 days) and 28 day
    dia 3, dia de la resolucion de la infeccion (o dia 7 y cada 7 dias hasta resolucion) y dia 28
    E.5.2Secondary end point(s)
    ? Effect of albumin administration on 90-day survival.
    ? Effect of albumin infusion on the incidence of renal dysfunction, type-1 and type-2 HRS during hospitalization.
    ? Effect of albumin on circulatory function estimated by changes in plasma levels of renin and noradrenaline and by changes in serum lactate levels among infection diagnosis, day 3 and infection resolution.
    ? Effect of albumin on serum levels of IL-6, TNF-alpha and NOX and on plasma levels of vWF:Ag at infection diagnosis and at infection resolution.
    ? Effect of albumin on blood leukocyte count and serum CPR levels during infection.
    ? Effect of albumin infusion on the development of other individual organ failures (renal, liver, cerebral, circulatory, coagulation and respiratory) during hospitalization.
    ? Effect of albumin on the development of other individual organ failures (renal, liver, cerebral, circulatory, coagulation and respiratory), acute-on-chronic liver failure (ACLF type 1, 2 and 3 according to the Canonic Study), CLIF-SOFA score, CLIF-Consortium score, Child-Pugh score and MELD score during hospitalization.
    ? Evaluation of predictive factors of HRS and ACLF development in non-SBP infections.
    ? Samples (blood, plasma, serum and urine) will be obtained and stored for genomic, proteomic and standard biochemical investigations in future ancillary studies related to the aim of the study.
    ? Mortalidad a los 90 días
    ? Disfunción renal y síndrome hepatorrenal durante la hospitalización
    ? Cambios en los niveles plasmáticos de renina, noradrenalina y lactato durante el tratamiento de la infección.
    ? Cambios en los niveles plasmáticos de IL6, TNF, óxido nítrico y von Willebrand factor.
    ? Cambio en los niveles plasmáticos de la proteína C reactiva y leucocitos
    ? Cambios en los score pronósticos: CLIF-SOFA, CLIF-consortium, CHILD-PUGH, MELD
    ? Incidencia de un nuevo fallo de órgano durante la hospitalización
    ? Incidencia de Acute-on-Chronicliverfailure (ACLF) y sus subtipos durante la hospitalización
    ? Factores de riesgo de SHR, ACLF y mortalidad a corto plazo
    ? Estancia hospitalaria (longitud)
    ? Causas de muerte.
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 3, day of infection resolution (or day 7 and every 7 days) day 28 and day 90
    dia 3, dia de la resolucion de la infeccion (o dia 7 y cada 7 dias hasta resolucion) dia 28 y dia 90
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 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) 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 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
    no tratamiento
    lack of treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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
    Premature termination based on:
    ?? Post-consent determination of ineligibility based on safety or eligibility criteria
    ?? Physician?s judgment following an adverse event
    ?? Patient?s decision
    ?? Termination of the trial by a regulatory authority
    ?? Any other reason for withdrawal that the trial physician or patient feels is in the best interest of the patient
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 362
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with advanced cirrhosis may develop encephalopathy . This complication is not an exclusion criteria. A relative will be asked for informed consent and the patient will confirm the participation afterwards, when encephalopathy is resolved.
    Los pacientes con cirrosis avanzada pueden desarrollar encefalopatia, y ello no seria motivo de exclusion. Se le pedira consentimiento informado a un familiar y el paciente confirmara su participacion posteriormente, tras resolverse la encefalopatia
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 490
    F.4.2.2In the whole clinical trial 512
    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
    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 Decision2013-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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