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    Summary
    EudraCT Number:2016-001789-28
    Sponsor's Protocol Code Number:IG1601
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-31
    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 ConcernedPoland - Office for Medicinal Products
    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
    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
    A.3.2Name or abbreviated title of the trial where available
    PRECIOSA
    A.4.1Sponsor's protocol code numberIG1601
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03451292
    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 AddressAv. 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.3.4Pharmaceutical 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 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 % 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
    Subjects with decompensated cirrhosis and ascites
    E.1.1.1Medical condition in easily understood language
    Cirrhosis and ascites
    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.
    Evaluar el efecto del tratamiento médico estándar (TME) más la administración prolongada de Albutein 20% (TME + Albutein 20%) en la supervivencia libre de trasplante a 1 año versus el TME 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
    - Evaluar los efectos de la administración del TME + Albutein 20% a los 3 y 6 meses de supervivencia libre de trasplante y la supervivencia global
    versus el TME solo.

    - Evaluar los efectos de la administración del TME + Albutein 20% sobre la supervivencia global a 1 año versus el TME solo

    - Evaluar el número total de paracentesis y la incidencia de ascitis refractaria según los criterios del Club Internacional de Ascitis (ICA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject ≥18 years of age.
    2v5. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
    3v5. Subjects who have been hospitalized 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 Screening.
    4v5. This criterion has been removed from Version 5 of the protocol.
    5. In subjects with cirrhosis due to HBV, decompensation must occur in the setting of continuous (no less than 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 (subjects receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study).
    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.
    9v5. CLIF-C AD score > 50 points at screening.
    1. Hombre o mujer ≥ 18 años de edad.
    2v5. Sujetos con diagnóstico de cirrosis hepática (basado en las características clínicas, de laboratorio, endoscópicas y ecográficas o en la histología)
    3v5. Sujetos que han sido hospitalizados por descompensación aguda de cirrosis hepática con ascitis (o con antecedentes de ascitis que requieren terapia diurética) con o sin ACLF al ingreso o durante la hospitalización pero sin ACLF en la selección.
    4v5. Este criterio se ha eliminado en la Versión 5 del protocolo.
    5. En los sujetos con cirrosis debida al virus de la hepatitis B, la descompensación debe ocurrir en el ámbito de la terapia antivírica adecuada continua (no menos de 3 meses).
    6. En los sujetos con cirrosis debida al virus de la hepatitis C, solo se incluirán pacientes
    descompensados que no recibirán terapia antivírica durante el período del estudio. (Los sujetos que hayan recibido terapia antiviral en los 14 dias previos a la visita de reclutamiento no pueden ser incluidos en el estudio).
    7. En los sujetos con cirrosis debida a hepatitis autoinmunitaria, la descompensación debe ocurrir en el ámbito de una terapia inmunodepresora continua.
    8. Los sujetos deben estar dispuestos y ser capaces de proporcionar el consentimiento informado por escrito o tener un representante autorizado capaz de proporcionar el consentimiento informado por escrito en nombre del sujeto según la ley local y la política institucional.
    9v5. Puntuación CLIF-C AD > 50 puntos en el momento de la selección.
    E.4Principal exclusion criteria
    1v5. Subjects with ACLF at Screening
    2v5. Subjects with type 1 HRS currently on treatment with vasoconstrictors or hemodialysis.
    3. Subjects with TIPS or other surgical porto-caval shunts.
    4v5. Subjects with refractory ascites as defined by ICA criteria without any other event of
    acute decompensation.
    5v5. This criterion has been removed in protocol Version 5.
    6v5. Subjects receiving dual anti-platelet therapy or anti-coagulant therapy (exception:
    DVT prophylaxis).
    7v5. Subjects with ongoing endoscopic eradication of esophageal varices with ≤ 2
    endoscopic sessions completed before screening.
    8. This criterion has been removed from protocol Version 5
    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.
    10v4. Subjects with acute or chronic heart failure (New York Heart Association [NYHA]).
    11. Subjects with severe (grade III or IV) pulmonary disease (Global Obstructive Lung
    Disease [GOLD]).
    12v5. Subjects with nephropathy with renal failure with serum creatinine >2 mg/dL or
    systemic hypertension.
    13v5. This criterion has been removed from protocol Version 5.
    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 effective methods of contraception (oral, injectable, or implanted hormonal
    methods of contraception, placement of an intrauterine device or intrauterine system,
    condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male
    sterilization, or true abstinence*) throughout the study.
    * True abstinence: When this is in line with the preferred and usual lifestyle of the
    subject (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation
    methods], declaration of abstinence for the duration of the clinical study,
    and withdrawal are not acceptable methods 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.
    20v4. Subjects with active drug addiction (exceptions: active alcoholism or marijuana).
    21. In the opinion of the investigator, the subject may have compliance problems with the
    protocol and the procedures of the protocol.
    22. Subjects with ongoing or recent variceal bleeding (subjects can be included 2 weeks
    after hemorrhagic episode).
    23. Subjects with septic shock at screening.
    24. Subjects with ongoing SBP infection (subjects can be included upon resolution).
    25. Subjects with current infection of COVID19, those who are less than 14 days post recovery, or those who have clinical signs and symptoms consistent with COVID19 infection.
    1v5. Sujetos con ACLF en la selección.
    2v5. Sujetos con SHR tipo I actualmente en tratamiento con vasoconstrictores o en
    hemodiálisis.
    3. Sujetos con DPIT u otras derivaciones porto-cava quirúrgicas.
    4V5. Sujeto con un diagnóstico establecido de ascitis refractaria de acuerdo con los
    criterios del ICA.
    5v5. Este criterio se ha eliminado en la Versión 5 del protocolo.
    6v5 Sujetos que reciban doble dosis de tratamiento con antiagregantes plaquetarios o
    anticoagulantes (excepción: profilaxis de TVP).
    7v5. Sujetos con erradicación endoscópica de varices esofágicas en curso con < 2 sesiones
    completadas antes de la visita de selección.
    8. Este criterio se ha eliminado en la Versión 5 del protocolo
    9. Sujetos con evidencia de neoplasia maligna localmente avanzada o metastásica
    actual. Se pueden incluir sujetos con carcinoma hepatocelular dentro de los criterios de Milán (1
    nódulo ≤ 5 cm o 3 nódulos ≤ 3 cm), cáncer de piel no melanocítico, o cáncer de mama o
    próstata controlado.
    10v4. Sujetos con insuficiencia cardiaca crónica o aguda (Asociación del Corazón de Nueva York, [NYHA, por sus siglas en inglés]).
    11. Sujetos con enfermedad pulmonar grave (de grado III o IV) (enfermedad pulmonar obstructiva global [GOLD, por sus siglas en inglés]).
    12v5. Sujetos con nefropatía con fallo renal con una creatinina sérica >2 mg/dL o hipertensión sistémica.
    13v5. Este criterio se ha eliminado en la Versión 5 del protocolo.
    14. Sujetos con trastornos psiquiátricos graves.
    15. Sujetos con infección conocida por el virus de la inmunodeficiencia humana (VIH)
    o que tengan signos y síntomas clínicos compatibles con la infección por el VIH actual.
    16. Mujeres que estén embarazadas, en período de lactancia o si están en edad fértil, que no estén dispuestas a utilizar un método anticonceptivo altamente eficaz (métodos anticonceptivos hormonales orales, inyectables o implantados, colocación de un
    dispositivo intrauterino o sistema intrauterino, preservativo o tapón oclusivo con
    espermicida en espuma/gel/crema/supositorio, esterilización masculina, o abstinencia
    real*) durante todo el estudio.
    * Abstinencia real: cuando esto está en consonancia con el estilo de vida preferido y
    habitual del sujeto (la abstinencia periódica [p. ej., los métodos de calendario, de ovulación, sintotérmico o de posovulación], la declaración de abstinencia durante la duración del estudio clínico y la marcha atrás no son métodos anticonceptivos aceptables).
    17. Sujetos con trasplante hepático previo.
    18. Sujetos con hipersensibilidad conocida o sospechosa a la albúmina.
    19. Sujetos que participen en otro estudio clínico en los 3 meses anteriores a la selección.
    20v4. Sujetos con drogadicción activa (excepciones: alcoholismo o marihuana activo).
    21. En opinión del investigador, el sujeto puede tener problemas de cumplimiento del
    protocolo y los procedimientos del protocolo.
    22. Sujetos con sangrado varicoso en curso o reciente (los sujetos pueden incluirse 2 semanas después del episodio hemorrágico).
    23. Sujetos con shock séptico en la visita de selección
    24. Sujetos con infección por PBE en curso (los sujetos pueden incluirse previa
    resolución).
    25. Sujetos con infección actual por COVID 19, aquellos recuperados en los últimos 14 días o aquellos que tienen signos y síntomas clínicos compatibles con la infección por COVID 19.
    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.
    La variable primaria de la eficacia es comparar la supervivencia libre de trasplante a 1 año en la población con intención de tratar (ITT) entre el grupo tratado con TME + Albutein 20% y el grupo TME solo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 año
    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.
    Las variables secundarias de eficacia son evaluar los efectos del tratamiento con SMT + Albutein al 20% versus SMT en: 1) supervivencia global y libre de trasplantes a 3 y 6 meses, 2) supervivencia global a 1 año y 3) número total de paracentesis y la incidencia de ascitis refractaria.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 and 6 months and 1 year.
    3 y 6 meses y 1 año.
    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
    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 concerned9
    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 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
    Canada
    United States
    France
    Poland
    Bulgaria
    Spain
    Germany
    Italy
    Belgium
    Bosnia and Herzegovina
    Denmark
    Hungary
    Serbia
    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
    LPLV
    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
    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 Decision2022-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-22
    P. End of Trial
    P.End of Trial StatusOngoing
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