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    Summary
    EudraCT Number:2021-000680-74
    Sponsor's Protocol Code Number:IC/LV/ACZ/PCHC
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-000680-74
    A.3Full title of the trial
    Multicenter, randomized, double-blind, comparative clinical trial to assess the efficacy of Zinc Acexamate versus a placebo in improving the prognosis of patients with advanced chronic liver disease (cACLD).
    Ensayo clínico multicéntrico, aleatorizado, a doble ciego, comparativo para valorar la eficacia del Acexamato de Zinc frente a un placebo en la mejoría del pronóstico de pacientes con enfermedad hepática crónica avanzada (cACLD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter, randomized, double-blind, comparative clinical trial to assess the efficacy of Zinc Acexamate versus a placebo in improving the prognosis of patients with advanced chronic liver disease (cACLD).
    Ensayo clínico multicéntrico, aleatorizado, a doble ciego, comparativo para valorar la eficacia del Acexamato de Zinc frente a un placebo en la mejoría del pronóstico de pacientes con enfermedad hepática crónica avanzada (cACLD).
    A.4.1Sponsor's protocol code numberIC/LV/ACZ/PCHC
    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 SponsorFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    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 supportFondos propios del promotor
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    B.5.2Functional name of contact pointJoan Genescà
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall d'Hebron, 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934893000
    B.5.6E-mailjoan.genesca@vallhebron.cat
    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 Copinal 300 mg cápsulas
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Viñas, 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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZinc acexamate
    D.3.9.1CAS number 70020-71-2
    D.3.9.2Current sponsor codeACZ
    D.3.9.3Other descriptive nameZINC ACEXAMATE
    D.3.9.4EV Substance CodeSUB12414MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    compensated advanced chronic liver disease
    enfermedad hepática crónica avanzada compensada
    E.1.1.1Medical condition in easily understood language
    chronic liver disease
    enfermedad hepática crónica
    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 10001422
    E.1.2Term Advanced chronic liver disease
    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
    To evaluate whether the oral administration of zinc acexamate (ACZ) at a dose of 600mg/day (equivalent to 100mg/day of elemental zinc) to patients with cACLD, improves your prognosis by reducing expected clinical events and the risk of suffering from them during during study follow-up.
    El objetivo principal de este ensayo clínico es evaluar si la administración oral de Acexamato de zinc (ACZ) a la dosis de 600mg/día (equivalente a 100 mg/día de zinc elemento) a pacientes con cACLD, mejora su pronóstico reduciendo los eventos clínicos esperables y el riesgo de padecerlos durante el seguimiento del estudio.
    E.2.2Secondary objectives of the trial
    To assess whether the administration of ACZ improves the risk of first decompensation and what type.
    To assess whether it reduces the overall risk of clinically significant portal hypertension [CSPH] estimated by the model described
    Assess whether it improves the risk of hepatocarcinoma.
    To study if it reduces the risk of bacterial infections.
    To assess whether it improves overall transplant-free survival.
    Assess whether it improves transplant-free survival in relation to liver-related deaths.
    Assess whether liver function improves as measured by the Child-Pugh score and the MELD scale.
    To assess whether the effects on the main variable or on each of the secondary variables separately, correlate with blood zinc levels during treatment.
    To evaluate the possible adverse effects of treatment with ACZ.
    Evaluar si la administración de ACZ mejora el riesgo de primera descompensación y que tipo.
    Evaluar si disminuye el riesgo global de hipertensión portal clínicamente significativa [CSPH] estimado por el modelo descrito
    Valorar si mejora el riesgo de hepatocarcinoma.
    Estudiar si disminuye el riesgo de infecciones bacterianas.
    Evaluar si mejora la supervivencia global libre de trasplante.
    Valorar si mejora la supervivencia libre de trasplante en relación a muertes de causa hepática.
    Valorar si mejora la función hepática medida por la puntuación de Child-Pugh y la escala MELD.
    Evaluar si los efectos sobre la variable principal o sobre cada una de las secundarias por separado, se correlacionan con los niveles de zinc en sangre durante el tratamiento.
    Evaluar los posibles efectos adversos al tratamiento con ACZ.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients of both sexes with cACLD diagnosed by hepatic stiffness by transition elastography >15 kPa.
    Age between 18 and 80 years, both inclusive.
    Absence of previous or current decompensation.
    In women of childbearing age, a possible pregnancy will be ruled out by means of a pregnancy test prior to the start of the study. Once the test has been carried out, the woman must use an effective contraceptive method during sexual intercourse to be maintained from the days prior to the start of treatment, and will continue to use them while the treatment is ongoing, as well as until a few days after finishing it.
    Sign the informed consent.

    Notes:
    Patients with esophageal varices at baseline endoscopy should be treated prophylactically with beta-blockers (preferably carvedilol) and may be included if they meet the inclusion criteria.
    Patients who present or have a high probability of presenting CSPH may be treated with beta-blockers (carvedilol preferably). The presence of CSPH is defined as:
    - HVPH ≥ 10 mm Hg
    - Presence of collateral circulation in imaging tests
    - Liver stiffness by transition elastography ≥25 kPa.
    Pacientes de ambos sexos con cACLD diagnosticada por una rigidez hepática por elastografía de transición >15 kpa.
    Edad comprendida entre los 18 y los 80 años, ambos inclusive.
    Ausencia de descompensación previa o actual.
    En las mujeres en edad fértil se descartará un posible embarazo mediante una prueba de embarazo previa al inicio del estudio. Una vez realizada la prueba, la mujer deberá utilizar un método anticonceptivo eficaz en las relaciones sexuales (ver Anexo I) que mantenga en los días previos al inicio del tratamiento, y seguirá aplicándolos mientras dure el tratamiento, así como hasta unos días después de finalizarlo.
    Firmar el consentimiento informado.

    Notas:
    Los pacientes que presenten varices esofágicas en la endoscopia basal deberán ser tratados profilácticamente con beta-bloqueantes (carvedilol preferentemente) y podrán ser incluidos, si cumplen los criterios de inclusión.
    Los pacientes que presenten o tengan alta probabilidad de presentar CSPH podrán ser tratados con beta-bloqueantes (carvedilol perferentemente). La presencia de CSPH queda definida como:
    - HVPH ≥ 10 mm Hg
    - Presencia de circulación colateral en las pruebas de imagen
    - Rigidez hepática por elastografía de transición ≥25 kPa.
    E.4Principal exclusion criteria
    History or current presence of hepatocarcinoma.
    Concomitant systemic disease, with low short-term prognosis for life.
    Pregnancy, breastfeeding, or refusal to use contraceptive measures whilst participating in the study.
    Patients with cACLD due to HBV on antiviral treatment and with cACLD due to HCV cured with antiviral treatment.
    Antecedentes o presencia actual de hepatocarcinoma.
    Enfermedad concomitante sistémica, con pronóstico de vida bajo a corto plazo.
    Embarazo, lactancia, o negativa a emplear medidas anticonceptivas durante su participación en el estudio.
    Pacientes con cACLD por VHB en tratamiento antiviral y con cACLD por VHC curados con tratamiento antiviral.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of time-dependent clinical events during study follow-up, along with the distribution of CSPH risk estimated by the ANTICIPATE model.
    Clinical events are defined as the sum of:
    1. Hepatic decompensation defined as the presence of clinical ascites, gastrointestinal bleeding due to portal hypertension, and hepatic encephalopathy.
    2. Hepatocellular carcinoma.
    3. Death from liver causes (considering non-hepatic death as a competitive risk).
    4. Liver transplant.
    Aparición de eventos clínicos dependientes del tiempo, durante el seguimiento del estudio, junto con la distribución del riesgo de CSPH estimado por el modelo ANTICIPATE.
    Los eventos clínicos quedan definidos como la suma de:
    1. Descompensación hepática definida como presencia de ascitis clínica, hemorragia gastrointestinal por hipertensión portal y encefalopatía hepática.
    2. Carcinoma hepatocelular.
    3. Muerte de causa hepática (considerando la muerte de causa no hepática como riesgo competitivo).
    4. Trasplante hepático.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The clinical follow-up will be every 3 months during the first 2 years, and then every 6 months until the end of the stud. Specific tests will be every 12 months and routine tests every 6 months.
    El seguimiento clínico será cada 3 meses durante los 2 primeros años, y posteriormente cada 6 meses hasta al final del estudio.
    Las pruebas específicas serán cada 12 meses y las rutinarias cada 6 meses.
    E.5.2Secondary end point(s)
    The secondary variables will consist of the evolutionary development of each of the secondary objectives
    Las variables secundarias consistirán en el desarrollo evolutivo de cada uno de los objetivos secundarios
    E.5.2.1Timepoint(s) of evaluation of this end point
    The clinical follow-up will be every 3 months during the first 2 years, and then every 6 months until the end of the study. Specific tests will be every 12 months and routine tests every 6 months.
    El seguimiento clínico será cada 3 meses durante los 2 primeros años, y posteriormente cada 6 meses hasta al final del estudio.
    Las pruebas específicas serán cada 12 meses y las rutinarias cada 6 meses.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned15
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 150
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-14. Yes
    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 state300
    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
    No
    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 Decision2021-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-09
    P. End of Trial
    P.End of Trial StatusOngoing
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