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    Summary
    EudraCT Number:2017-002677-19
    Sponsor's Protocol Code Number:IG1605
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-15
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002677-19
    A.3Full title of the trial
    Pathogenesis of Acute on Chronic Liver Failure (ACLF) and Mechanisms of Action of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) in Decompensated Cirrhotic Subjects with Systemic Inflammation and ACLF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biological mechanisms of Acute on Chronic Liver Failure (ACLF) and Mechanisms of Action of Plasma Exchange with Human Serum Albumin 5% in Subjects with cirrhosis with systemic inflammation and ACLF
    A.3.2Name or abbreviated title of the trial where available
    ALADDIN
    A.4.1Sponsor's protocol code numberIG1605
    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.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
    Group 1 and 2:
    Subjects with cirrhosis with ACLF-1b, ACLF-2, or ACLF-3a detected either at admission or during
    hospitalization

    Group 3: Subject with cirrhosis hospitalized for Acute decompensation of cirrhosis (ascites, hepatic encephalopathy [HE], gastrointestinal hemorrhage, and/or bacterial infections)
    E.1.1.1Medical condition in easily understood language
    Group 1 and 2: Subjects with cirrhosis and diagnosed Acute-on-Chronic Liver Failure
    Group 3: Subjects with cirrhosis without diagnosed Acute-on-Chronic Liver Failure
    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 investigate the pathogenesis of systemic inflammation, organ failure (OF), and ACLF
    in cirrhosis
    To explore mechanisms of action of PE-A 5% in subjects with ACLF
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects enrolled in Group 1 and 2 must meet all the following inclusion criteria to be eligible for participation in this study:
    1. Be enrolled at European study centers of the APACHE study which are also participating in the ALADDIN study.
    2. Have signed the informed consent form (ICF) to participate in the ALADDIN study.

    Subjects enrolled in Group 3 must meet all the following inclusion criteria to be eligible for participation in this study:
    1. Male or female cirrhotic subject between 18 and 79 years of age.
    2. Hospitalized for AD of cirrhosis (ascites, HE, gastrointestinal hemorrhage and/or
    bacterial infections). Bacterial infections are considered an AD of cirrhosis only in
    subjects with prior history of decompensated cirrhosis.
    3. 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.
    E.4Principal exclusion criteria
    Subjects in Group 3 meeting any of the following exclusion criteria are NOT eligible for participation in the study:
    1. Subjects with ACLF (any grade).
    2. Subjects with septic shock lasting >1 hour that does not respond to fluid resuscitation intravenous
    (IV) therapy or pharmacologic-pressors.
    3. Subjects with active bacterial or fungal infection with hemodynamic instability.
    4. Subjects with active or recent bleeding (unless controlled for >48 hours).
    5. Subjects with chronic renal failure and currently receiving hemodialysis.
    6. 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, and controlled breast or prostate cancer, can be included).
    7. Subjects with severe chronic heart failure (New York Heart Association [NYHA] class
    III or IV).
    8. Subjects with severe pulmonary disease (Global Obstructive Lung Disease [GOLD] stage
    III or IV).
    9. Subjects with severe critical illness myopathy as defined clinically.
    10. Subjects with a known infection with human immunodeficiency virus (HIV) or clinical signs and symptoms consistent with current HIV infection.
    11. Females who are pregnant.
    12. Subjects with previous liver transplantation.
    13. Subjects receiving anti-platelet or anti-coagulant therapy.
    14. Participation in another clinical study within at least 30 days prior to screening.
    15. Subjects with active drug addiction.
    16. Subjects with a do-not-resuscitate order.
    17. Subjects who, in the opinion of the investigator, may have compliance problems with the
    protocol and the procedures of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    not applicable
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    pathogenesis
    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 No
    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 trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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
    In case of hepatic encephalopathy (HE).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    Subjetcs are encouraged to come to the clinic for final assessment as outlined in the protocol. At this time the PI would discuss ongoing treatment options based on the SOC (standard of care) of the PI.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-31
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