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    Summary
    EudraCT Number:2016-001789-28
    Sponsor's Protocol Code Number:IG1601
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-001789-28
    A.3Full title of the trial
    Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites
    Prevention of Mortality with Long-Term
    Administration of Human Albumin in Subjects with
    Decompensated Cirrhosis and Ascites
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term Albumin administration in cirrhotic patients with ascites
    Somministrazione a lungo termine di Albumina nei pazienti cirrotici con ascite
    A.3.2Name or abbreviated title of the trial where available
    PRECIOSA
    PRECIOSA
    A.4.1Sponsor's protocol code numberIG1601
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03451292
    A.5.4Other Identifiers
    Name:PRECIOSANumber:IG1601
    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 SponsorINSTITUTO GRIFOLS, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisationInstituto Grifols S.A.
    B.5.2Functional name of contact pointClinical and Pharmacovigilance
    B.5.3 Address:
    B.5.3.1Street AddressAvinguda de la Generalitat, 152-158
    B.5.3.2Town/ citySant Cugat del Vallès
    B.5.3.3Post code08174
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935710500
    B.5.5Fax number+34935712482
    B.5.6E-mailIGregulatory.affairs@grifols.com
    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 holderInstituto Grifols, S.A.
    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 nameAlbutein 20%
    D.3.2Product code [B05AA01]
    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 INNALBUMINA UMANA SOLUZIONE
    D.3.9.2Current sponsor codePRD451485
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Subjects with decompensated cirrhosis and ascites
    Soggetti con cirrosi scompensata e ascite
    E.1.1.1Medical condition in easily understood language
    Cirrhosis and ascites
    Cirrosi e ascite
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064704
    E.1.2Term Decompensated cirrhosis
    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
    To evaluate the effect of standard medical treatment (SMT) plus long-term Albutein 20% (SMT + Albutein 20%) administration on 1-year transplant-free survival versus SMT alone.
    • Valutare l'effetto della somministrazione del trattamento medico standard (SMT, standard medical treatment) più Albutein 20% a lungo termine (SMT + Albutein 20%) sulla sopravvivenza senza trapianto a 1 anno rispetto a SMT da solo
    E.2.2Secondary objectives of the trial
    - To evaluate the effects of SMT + Albutein 20% administration on 3- and 6-month transplant-free and overall survival versus SMT alone

    - To evaluate the effects of SMT + Albutein 20% administration on 1-year overall survival versus SMT alone

    - To evaluate the total number of paracenteses and the incidence of refractory ascites according the International Club of Ascites (ICA) criteria
    • Valutare gli effetti della somministrazione di SMT + Albutein 20% sulla sopravvivenza senza trapianto a 3 e 6 mesi e sulla sopravvivenza globale rispetto a SMT da solo
    • Valutare gli effetti della somministrazione di SMT + Albutein 20% sulla sopravvivenza globale a 1 anno rispetto a SMT da solo
    • Valutare la quantità totale di paracentesi e l'incidenza dell'ascite refrattaria secondo i criteri dell'International Club of Ascites (ICA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject =18 years of age.
    2. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology) and uncomplicated ascites according to the ICA criteria.
    3. Subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without ACLF at admission or during hospitalization but without ACLF at discharge.
    4. Subjects with ongoing diuretic treatment with an anti-mineralocorticoid drug at a dose of =100 mg/day and furosemide =40 mg/day independent of response to treatment.
    5. In subjects with cirrhosis due to HBV, decompensation must occur in the setting of continuous (not <3 months) appropriate antiviral therapy.
    6. In subjects with cirrhosis due to HCV, only decompensated patients who will not receive antiviral therapy during the study period will be included.
    7. In subjects with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.
    8. Subjects must be willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the subject in accordance with local law and institutional policy.
    1. Soggetto di sesso maschile o femminile con età =18 anni.
    2. Soggetti con diagnosi di cirrosi epatica (sulla base di riscontri clinici, di laboratorio, endoscopici e ultrasonografici o di referti istologici) e ascite non complicata secondo i criteri ICA.
    3. Soggetti dimessi dopo essere stati ospedalizzati per scompenso acuto di cirrosi epatica con ascite (oppure con pregressa storia di ascite richiedente terapia diuretica), con o senza ACLF alle dimissioni o durante l'ospedalizzazione, ma senza ACLF alle dimissioni.
    4. Soggetti in terapia diuretica continua con un farmaco anti-mineralocorticoide a una dose di =100 mg/giorno e furosemide =40 mg/giorno indipendentemente dalla risposta al trattamento.
    5. Nei soggetti con cirrosi dovuta al virus dell'epatite B, lo scompenso deve verificarsi in un regime di adeguata terapia antivirale continua (non <3 mesi).
    6. Per quanto concerne i soggetti con cirrosi dovuta al virus dell'epatite C, saranno inclusi solo pazienti con scompenso che non riceveranno terapie antivirali durante il periodo dello studio.
    7. Nei soggetti con cirrosi dovuta a epatite autoimmune, lo scompenso deve verificarsi in un regime di terapia immunosoppressiva continua.
    8. I soggetti devono essere disposti e capaci di rilasciare il loro consenso informato scritto oppure devono delegare un rappresentante autorizzato a rilasciare detto consenso informato scritto a loro nome, conformemente alle leggi locali e alla politica istituzionale.
    E.4Principal exclusion criteria
    1. Subjects with ongoing ACLF at discharge.
    2. Subjects with ongoing or recent (within the last 30 days) HRS, infection, or bleeding complications.
    3. Subjects with TIPS or other surgical porto-caval shunts.
    4. Subject with an established diagnosis of refractory ascites as defined by ICA criteria.
    5. Subjects requiring =2 paracenteses during the previous 30 days.
    6. Subjects receiving anti-platelet therapy or anti-coagulant therapy during the previous 30 days.
    7. Subjects with ongoing endoscopic eradication of esophageal varices at discharge.
    8. Subjects with HE grade III or IV.
    9. Subjects with evidence of current locally advanced or metastatic malignancy. Subjects with hepatocellular carcinoma within the Milan criteria [1 nodule =5 cm or 3 nodules =3 cm]], non-melanocytic skin cancer, or controlled breast or prostate cancer can be included.
    10. Subjects with chronic heart failure (New York Heart Association [NYHA]).
    11. Subjects with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease [GOLD]).
    12. Subjects with serum creatinine >2.0 × upper limit of normal ([ULN] based on local laboratory results obtained prior to discharge).
    13. Subjects with organic nephropathy as defined by ICA criteria.
    14. Subjects with severe psychiatric disorders.
    15. Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.
    16. Females who are pregnant, breastfeeding, or, if of childbearing potential, unwilling to practice a highly effective method of contraception.
    17. Subjects with previous liver transplantation.
    18. Subjects with known or suspected hypersensitivity to albumin.
    19. Subjects participating in another clinical study within 3 months prior to screening.
    20. Subjects with active drug addiction.
    21. In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol.
    1. Soggetti con ACLF in atto al momento delle dimissioni.
    2. Soggetti con HRS, infezione o complicanze emorragiche in atto o recenti (negli ultimi 30 giorni).
    3. Soggetti con TIPS o altri shunt porto-cavali chirurgici.
    4. Soggetti con diagnosi confermata di ascite refrattaria, come definito secondo i criteri ICA.
    5. Soggetti richiedenti =2 paracentesi nel corso degli ultimi 30 giorni.
    6. Soggetti trattati con terapia antitrombotica o anticoagulante nel corso degli ultimi 30 giorni.
    7. Soggetti con eradicazione endoscopica in corso delle varici esofagee al momento delle dimissioni.
    8. Soggetti con HE di grado III o IV.
    9. Soggetti con evidenza di attuale tumore maligno localmente avanzato o metastatico. Possono essere inclusi soggetti con carcinoma epatocellulare secondo i criteri Milano (1 nodulo =5 cm o 3 noduli =3 cm), carcinoma della pelle non melanocitario o carcinoma della mammella o della prostata controllato.
    10. Soggetti con insufficienza cardiaca cronica (secondo i criteri della New York Heart Association [NYHA]).
    11. Soggetti con malattia polmonare severa (grado III o IV) (secondo i criteri della Global Initiative for Chronic Obstructive Lung Disease [GOLD]).
    12. Soggetti con creatinina sierica >2,0 volte il limite superiore della norma ([ULN] sulla base dei risultati degli esami di laboratorio ottenuti prima delle dimissioni).
    13. Soggetti con nefropatia organica, come definito secondo i criteri ICA.
    14. Soggetti con gravi disturbi psichiatrici.
    15. Soggetti con nota infezione dal virus dell'immunodeficienza umana (HIV) oppure con segni e sintomi clinici indicativi di attuale infezione da HIV.
    16. Soggetti di sesso femminile in stato di gravidanza, in allattamento o in età potenzialmente fertile e non disposti ad adottare un metodo contraccettivo altamente efficace (contraccettivo orale, iniettabile o ormonale impiantato, inserimento di spirale o dispositivo intrauterino, profilattico o cappuccio occlusivo con schiuma/gel/crema/supposta spermicida, sterilizzazione maschile o reale astinenza*) per l'intera durata dello studio.
    * Reale astinenza: se questa pratica è in linea con lo stile di vita abituale e preferito dal soggetto (l'astinenza periodica [ad es. metodo del calendario, dell'ovulazione, sintotermico, del periodo post-ovulazione], la dichiarazione di astinenza per la durata dello studio clinico e il coito interrotto non sono metodi anticoncezionali accettabili).
    17. Soggetti sottoposti a precedente trapianto di fegato.
    18. Soggetti con nota o sospetta ipersensibilità all'albumina.
    19. Soggetti partecipanti ad un altro studio clinico nei 3 mesi precedenti lo screening.
    20. Soggetti con tossicodipendenza attiva.
    21. Soggetti che, a discrezione dello sperimentatore, possono avere problemi di compliance con il protocollo e le procedure dello stesso.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is to compare the 1-year transplant-free survival in the intent-to-treat (ITT) population between the SMT + Albutein 20% treatment group and the SMT alone group.
    L'endpoint primario di efficacia è confrontare la sopravvivenza senza trapianto a 1 anno nella popolazione "intent to treat" (ITT) tra il gruppo di trattamento SMT + Albutein 20% e il gruppo SMT da solo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 anno
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are to assess the effects of SMT + Albutein 20% treatment versus SMT alone on: 1) 3- and 6-month transplant-free and overall survival, 2) 1-year overall survival, and 3) total number of paracenteses and the incidence of refractory ascites.
    Gli endpoint secondari di efficacia sono valutare gli effetti del trattamento SMT + Albutein 20% rispetto a quelli del trattamento SMT da solo in relazione a: (1) sopravvivenza senza trapianto a 3 e 6 mesi e sopravvivenza globale, (2) sopravvivenza globale a 1 anno, e (3) quantità totale di paracentesi e incidenza dell'ascite refrattaria.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 and 6 months and 1 year.
    3 mesi, 6 mesi e 1 anno.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Terapia Medica Standard in accordo alla pratica clinica locale
    Standard Medical Treatment according to the local guidelines
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Belgium
    Denmark
    France
    Germany
    Italy
    Spain
    United Kingdom
    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
    Ultima visita dell'ultimo soggetto (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 410
    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
    Nessuno
    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 Decision2018-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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