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    Summary
    EudraCT Number:2013-002416-27
    Sponsor's Protocol Code Number:INFECIR2
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-04-25
    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 ConcernedGermany - PEI
    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.
    Die Gabe von Albumin zur Prävention von hepatorenalem Syndrom und Tod bei Patienten mit Leberzirrhose und bakteriellen Infektionen, ausgenommen der spontan bakteriellen Peritonitis (SBP), die ein hohes Mortalitätsrisiko im Krankenhaus haben
    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.
    Die Gabe von Albumin zur Prävention von hepatorenalem Syndrom und Tod bei Patienten mit Leberzirrhose und bakteriellen Infektionen, ausgenommen der spontan bakteriellen Peritonitis (SBP), die ein hohes Mortalitätsrisiko im Krankenhaus haben
    A.3.2Name or abbreviated title of the trial where available
    The INFECIR-2 Albumin Prevention Study
    INFECIR 2 Albumin Präventionsstudie
    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 AddressHospital Clinic - Hepatic ICU; C/Villaroel, 170 - ESC 7- Planta 3a
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number003493227 54 00 3329
    B.5.5Fax number003493227 9348
    B.5.6E-mailJFDEZ@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 Albutein 20%
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlbumin
    D.3.9.3Other descriptive nameHuman serum albumin
    D.3.9.4EV Substance CodeSUB20344
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Male and female cirrhotic patients with advanced cirrhosis (serum creatinine ≥ 1.2 mg/dl, serum sodium ≤ 130 mEq/l and/or serum bilirubin ≥4 mg/dl), and diagnosis of urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection at hospital admission or during hospitalization.
    - Männer und Frauen im Alter = oder > 18
    -Leberzirrhose (Laborwerte: Kreatinin ≥ 1,2 mg/dl, Natrium ≤ 130 mmol/l und/oder Bilirubin ≥ 4 mg/dl)
    -Diagnose eines bakteriellen Infekts (Harnwegsinfekt, Pneumonie, spontane oder sekundäre Bakteriämie, Haut/Weichteilinfekt, akute Cholangitis, Verdacht auf bakterielle Infektion)
    E.1.1.1Medical condition in easily understood language
    Patients with advanced cirrhosis ,and urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will be included
    Patienten mit fortgeschrittener Leberzirrhose und einer bakteriellen Infektion (nicht SBP) - (Harnwege, Luftwege, spontane/sekundäre Bakteriämie, Haut/Weichteile, akute Cholangitis).
    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 18.1
    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 18.1
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10019641
    E.1.2Term Hepatic cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 18.1
    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 18.1
    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
    Effect of albumin administration on in-hospital survival.
    Effekt der Albumingabe auf das Überleben im Krankenhaus
    E.2.2Secondary objectives of the trial
    Effect of albumin administration on
    •28-day and 90 day survival
    • incidence of AKI, renal dysfunction, type-1 and 2 HRS during hospitalization
    • circulatory function estimated by changes in plasma levels of renin and noradrenaline and in serum levels of lactate among infection diagnosis, day 3 and infection resolution
    • serum levels of IL-6, tTNF-alpha and nitric oxide (NOX) and on plasma levels of von Willebrand factor (vWF:Ag) at diagnosis and resolution of infection
    • blood leukocyte count and serum C-reactive protein levels (CRP) during infection
    • 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 including antibiotic prophylaxis.
    Effekt d. Albumingabe auf
    - das 28 und 90-Tg-Überleben
    -die Inzidenz einer Nierenfunktionseinschränkung, des hepatorenalen Syndroms Typ 1 oder 2
    -die Kreislauffunktion, gemessen an Renin-, Noradrenalin- und Laktat-Spiegeln im Serum
    -die Serumspiegel von IL-6, TNF-alpha, NO und von Willebrand Faktor (im Plasma)
    -auf die Leukozytenzahl und die CRP-Konzentration
    -Effekt d. Albumingabe auf die Entwicklung von Organversagen, gemessen mit verschiedenen Scores
    -Bewertung des prädiktiven Faktors eines HRS und ACLF Entwicklung bei nicht-SBP Infektionen einschließlich Antibiotika Prophylaxe.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients with age ≥ 18 years.
    2. Diagnosis of liver cirrhosis established by histology or by the combination of clinical, analytical and ultrasonographic data.
    3. Diagnosis of urinary infection, pneumonia, spontaneous or secondary bacteremia, 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: signs of systemic inflammation (described in criterion number 4) and more than 10 leukocytes per high-power field in urine or a positive reagent strip;
    (b) Pneumonia: signs of infection (described below) and presence of new infiltrates on chest x-ray;
    (c) Skin/soft tissue infection: signs of infection and physical exam findings of swelling, erythema, heat and tenderness in the skin;
    (d) Acute cholangitis: signs of infection and cholestasis, compatible symptoms (right upper quadrant pain and jaundice) and radiological data of biliary obstruction;
    (e) Spontaneous bacteremia: positive blood cultures and no cause of bacteremia;
    (f) Secondary bacteremia: positive blood and catheter cultures or bacteremia within 24h after invasive procedure;
    (g) Suspected bacterial infection: signs of systemic inflammation (described in criterion number 4) but no identifiable origin of this infection (polymorphonuclear cells in ascitic and pleural fluid < 250/mm3, normal urine sediment and chest X-ray).
    4. Patients with uncomplicated urinary infections or suspected bacterial infections will require the presence of signs of systemic inflammation: at least 1 diagnostic criterion of systemic inflammatory response syndrome (SIRS) and high serum CRP levels (≥1 mg/dL or 10 mg/L). This criterion will not be required for the rest of infections.
    5. Analytical data of renal and/or liver dysfunction (serum creatinine ≥1.2 mg/dl, serum sodium ≤130 mEq/l or serum bilirubin ≥4 mg/dl). Patients with pneumonia or documented bacteremia (positive blood cultures) will require the presence of at least 1 of these analytical criteria to be included in the study. Patients with urinary infection, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will require 2 or more criteria for inclusion.
    -Männer und Frauen 18 Jahre und älter
    -Leberzirrhose
    -Diagnose eines bakteriellen Infekts (z.B. Harnwegsinfekt, Pneumonie, spontane oder sekundäre Bakteriämie, Haut/Weichteilinfekt, akute Cholangitis, Verdacht auf bakterielle Infektion) entsprechend der Diagnosekriterien
    -Bei Patienten mit unkomplizierten HWI oder dem Verdacht auf bakterielle Infektion muss mindestens 1 diagnostisches Kriterium einer SIRS vorliegen und erhöhte CRP Werte (≥1 mg/dL or 10 mg/L); dieses Kriterium ist nicht erforderlich bei anderen Infektionen
    -Vorhandensein einer Nieren- und/oder Leberfunktionsstörung (Laborwerte: (serum creatinine ≥1.2 mg/dl, serum sodium ≤130 mEq/l oder serum bilirubin ≥4 mg/dl); bei Patienten mit Pneumonie oder dokumentierter Bakteriämie (eindeutige Blutkultur) erfordert es die Präsenz eines dieser analytischen Kriterien, um in die Studie eingeschlossen werden zu können; bei Patienten mit HWI, Haut/Weichteilinf., akuter Cholangitis oder Verdacht auf bakterielle Infektion werden 2 oder mehr Kriterien erforderlich.
    E.4Principal exclusion criteria
    1. More than 72h after infection diagnosis.
    2. Pre-menopausal women (last menstruation ≤ 12 months prior to enrolment) who are nursing or pregnant or are of child bearing potential and are not practicing an acceptable method of birth control. The methods considered as acceptable are: intrauterine devices, double barrier method (condom or diaphragm with spermicide), hormonal methods (oral contraceptive, contraceptive patch, long-acting injectable contraceptive) and tubal ligation.
    3. Acute or sub-acute liver failure without underlying cirrhosis.
    4. Septic shock (mean arterial pressure below 60 mmHg during more than 1 hour despite adequate fluid resuscitation and need of vasopressor drugs).
    5. Severe acute respiratory distress syndrome [PaO2/Fi02 ≤100 or a pulse oximetric saturation (SpO2) to FiO2 ratio ≤89].
    6. Active or recent variceal bleeding (unless controlled for > 48h).
    7. Ongoing type-1 HRS (IAC criteria; serum creatinine ≥ 2.5 mg/dl).
    8. Type-3 ACLF (defined according to the Canonic Study criteria).
    9. Hemodialysis or other type of renal replacement therapy.
    10. Evidence of current malignancy (except for hepatocellular carcinoma within Milan criteria or non-melanocytic skin cancer).
    11. Previously known moderate or severe chronic heart failure (NYHA class II, III or IV).
    12. Previously known severe chronic pulmonary disease (GOLD IV).
    13. Previously known severe psychiatric disorders that prevent the patient from giving informed consent and from making autonomous decisions.
    14. Previous liver transplantation.
    15. Previously known HIV infection (except for patients under antiretroviral therapy with undetectable viral load, CD4 levels > 200/mm3 and no previous history of opportunistic infections diagnostic of AIDS).
    16. Contraindications to albumin (allergy, signs of pulmonary edema).
    17. Albumin administration (≥ 80 g) in the last 2 days.
    18. Spontaneous bacterial peritonitis co-infection.
    19. Usage of any investigational drug within 90 days prior to randomization or the planned use of an investigational drug during the course of the current study.
    20. Refusal to participate.
    21. 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.
    22. Physician and team not committed to intensive care if needed.
    -Diagnose des bakteriellen Infekts ist mehr als 72 Stunden zurückliegend
    -Pre-menopausale Frauen, die stillen oder schwanger sind oder keine zuverlässige Schwangerschaftsverhütung anwenden. Zu den zuverlässigen Methoden der Empfängnisverhütung gehören:
    Intrauterinpessar, Doppelte Barriere-Methoden (Kondom oder Diaphragma mit Spermizide), hormonelle Empfängnisverhütung (orale Kontrazeptiva, Verhütungspflaster, lang anhaltende injezierbare Kontrazeptiva), Sterilisation.
    -(Sub-)Akutes Leberversagen ohne Zirrhose
    -Septischer Schock
    -ARDS (acute respiratory distress syndrome);[PaO2/Fi02 ≤100 or a pulse oximetric saturation (SpO2) to FiO2 ratio ≤89]
    -aktive oder jüngere Varizenblutung (ausgenommen unter Kontrolle > 48h)
    -Akute alkoholische Hepatitis (durch Biopsie gesichert), die eine spezifische Behandlung erfordert
    -anhaltendes Hepatorenales Syndrom Typ I (IAC criteria; serum creatinine ≥ 2.5 mg/dl)
    -ACLF Typ 3 (acute on chronic liver failure); (nach Canonic Study Kriterien definiert)
    -Hämodialyse oder andere Nierenersatzverfahren
    -Maligne Grunderkrankung (außer HCC innerhalb Milan Kriterien oder nicht melanozytärer Hautkrebs)
    -Bekannte moderate oder schwere Herzinsuffizienz ab NYHA II
    -Bekannte schwere COPD (GOLD IV)
    -Vorher bekannte schwere psychiatrische Störungen, die den Patienten daran hinter, ihr Einverständnis zu geben und autonome Entscheidungen zu treffen
    -Vorherige Lebertransplantationen
    -Bekannte HIV Infektion (Ausnahme: Patienten unter antiretroviraler Therapie mit unauffindbarer Viruslast, CD4 levels > 200/mm3 und keine Vorgeschichte opportunistischer Infektionen AIDS Diagnose
    -Kontraindikationen gegen Albumin (Allergie, Zeichen eines pulmonalen Ödems)
    -Albumingabe (≥ 80 g) in den letzten 2 Tagen
    -SBP Ko-Infektion
    -Anwendung von Prüfpäparaten innerhalb der letzten 90 Tage vor Randomisierung oder der geplante Gebrauch von Prüfpräparaten während der Durchführung dieser klinischen Prüfung
    -Ablehnung an der klinischen Prüfung teilzunehmen
    -Patienten, die vorher keine Einwilligung erteilen können und bei denen es keinen dokumentierten rechtlich stellvertretenden Entscheider gibt und es unwahrscheinlich ist, dass der Patient das Bewußtsein wiedererlangt oder die ausreichende Möglichkeit, nachfolgend die Einwilligung zu erteilen
    -Ablehnung eventuell erforderlicher intensivmedizinischer Maßnahmen durch die betreuenden Ärzte
    E.5 End points
    E.5.1Primary end point(s)
    Hospital survival in both treatment arms
    Überleben im Krankenhaus in beiden Behandlungsarmen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 3, day of infection resolution (or day 7 and every 7 days)
    Tag 3, Tag der Genesung von der Infektion (oder Tag 7 und jeder weitere 7. Tag)
    E.5.2Secondary end point(s)
    -Effect of albumin administration on 28-day-survival
    -Effect of albumin administration on 90-day survival.
    -Effect of albumin infusion on the incidence of renal dysfunction, AKI, 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 including antibiotic prophylaxis.
    -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.
    -Effekt der Albuminabgabe auf das 28-Tage-Überleben
    -Effekt der Albumingabe auf das 90-Tage-Überleben
    -Effekt der Albumingabe auf die Inzidenz einer Nierenfunktionseinschränkung, AKI, des hepatorenalen Syndroms Typ 1 oder 2 während des Krankenhausaufenthaltes
    -Effekt der Albumingabe auf die Kreislauffunktion, gemessen an Renin-, Noradrenalin- und Laktat-Spiegeln im Serum
    -Effekt der Albumingabe auf die Serumspiegel von IL-6, TNF-alpha, NO und von Willebrand Faktor (im Plasma)
    -Effekt der Albumingabe auf die Leukozytenzahl und die CRP-Konzentration
    -Effekt der Albumingabe auf die Entwicklung von einzelnen Organversagen, gemessen mit verschiedenen Scores
    -Auswertund der vorhersehbaren Faktoren einer HRS und ACLF Entwicklung in nicht-SBP Infektionen inklusive Antibiotika Prophylaxe
    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. A time window of ± 1 day is allowed in visits of days 7, 14, 21, 28 and 90.
    Tag 3, Tag der Genesung von der Infektion (oder Tag 7 und jeder weitere 7. Tag) , Tag 28 und Tag 90. Ein Zeitfenster von ± 1 Tag isf für die Besuche an Tag 7, 14, 21, 28 und 90 erlaubt.
    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
    keine Behandlung mit Albumin (nur Standardtherapie)
    lack of treatment with albumin (only standard therapy)
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Norway
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 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 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 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.
    Pat. mit fortgeschritt. Leberzirrhose können eine hep.Enzephalopathie entwickeln (nicht zustimmungsfähig sein). Ein gesetzlicher Vertreter/ Vorsorgebevollmächtigter entscheidet dann über Teilnahme- Einwilligung des Pat. wird nachträglich eingeholt
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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 Decision2014-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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