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    Summary
    EudraCT Number:2016-001787-10
    Sponsor's Protocol Code Number:IG1407
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-08-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-001787-10
    A.3Full title of the trial
    Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Acute-On-Chronic Liver Failure (ACLF) at High Risk of Hospital Mortality
    A.3.2Name or abbreviated title of the trial where available
    APACHE
    A.4.1Sponsor's protocol code numberIG1407
    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 Human Albumin Grifols 50g/l
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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 number5
    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 cirrhosis with ACLF-1b, ACLF-2, or ACLF-3a detected either at admission or during
    hospitalization
    E.1.1.1Medical condition in easily understood language
    Subjects with cirrhosis and 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 evaluate the effect of standard medical treatment (SMT) plus PE-A 5% (SMT+PE-A 5%) on 90-day overall survival.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of SMT+PE-A 5% on 90-day transplant-free survival.
    - To evaluate the effect of SMT+PE-A 5% on 28-day overall survival.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female cirrhotic subjects between 18 and 79 years of age.
    2. Subjects with ACLF-1b, ACLF-2, or ACLF-3a detected either at admission or during
    hospitalization (must be ACLF-1b, -2, or -3a within the Screening Period [a maximum of
    10 days]) (see Table 2-1 for ACLF grades in the study protocol).
    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.
    4. In case of HE, informed consent will be provided by a relative or a legally authorized
    representative (surrogate).
    E.4Principal exclusion criteria
    1. Subjects without ACLF.
    2. Subjects with ACLF-1a or ACLF-3b (see Table 2-1 for ACLF grades in the study protocol) after the Screening
    Period.
    3. Subjects fulfilling inclusion criteria that improve to no ACLF or to ACLF-1a or worsen
    to ACLF-3b during the Screening Period (between initial evaluation and time of randomization).
    4. Subjects with ACLF for more than 10 days prior to randomization.
    5. Subjects with acute or subacute liver failure without underlying cirrhosis.
    6. Subjects with septic shock lasting >1 hour that does not respond to fluid resuscitation-IV
    therapy or pharmacologic-pressors.
    7. Subjects with active bacterial or fungal infection with hemodynamic instability.
    8. Subjects with acute respiratory distress syndrome with peripheral oxygen saturation (SpO2) ≤89.
    9. Subjects with active or recent bleeding (unless controlled for >48 hours).
    10. Subjects with severe thrombocytopenia (≤20×109/L) (based on local laboratory assessment).
    11. Subjects with chronic renal failure and currently receiving hemodialysis.
    12. 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 [Appendix 5 of the study protocol]), non-melanocytic skin cancer, and controlled breast or prostate cancer can be included).
    13. Subjects with severe chronic heart failure (New York Heart Association [NYHA] class III or IV) (Appendix 6 of the study protocol).
    14. Subjects with severe pulmonary disease (Global Obstructive Lung Disease [GOLD] stage III or IV) (Appendix 7 of the study protocol).
    15. Subjects with severe myopathy as defined clinically.
    16. Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.
    17. Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method 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, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception).
    18. Subjects with previous liver transplantation.
    19. Subjects receiving anti-platelet or anti-coagulant therapy.
    20. Participation in another clinical study within at least 30 days prior to screening.
    21. Subjects with active drug addiction.
    22. Subjects with a do-not-resuscitate order.
    23. In the opinion of the investigator, the subject may have compliance problems with the
    protocol and the procedures of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is to compare the 90-day overall survival in the intent-to-treat (ITT) population between the SMT+PE-A 5% treatment group and the SMT control group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are to assess the effects of PE-A 5% on:
    1) 90-day transplant-free survival
    and
    2) 28-day overall survival
    versus SMT alone.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 and 90 days
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Austria
    Belgium
    Denmark
    France
    Germany
    Italy
    Portugal
    Spain
    United Kingdom
    United States
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 80
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 380
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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