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    Summary
    EudraCT Number:2016-001177-32
    Sponsor's Protocol Code Number:HEP101
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-001177-32
    A.3Full title of the trial
    Multicenter Phase II Safety and Preliminary Efficacy Study of two dose regimens of HepaStem in Patients with Acute on Chronic Liver Failure
    Estudio clínico multicéntrico de fase II para evaluar la seguridad y la eficacia preliminar de dos regímenes posológicos de HepaStem en pacientes con insuficiencia hepática crónica agudizada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study will study the safety and preliminary efficacy of HepaStem in cirrhotic patients who are hospitalized for Acute on Chronic Liver Failure (ACLF) or acute decompensation at risk of developing ACLF.
    The study is divided in 4 periods: screening period, active study period divided in treatment period and evaluation period, and long-term safety follow-up.
    El estudio evaluará la seguridad y la eficacia preliminar de HepaStem en pacientes cirróticos que hayan sido hospitalizados por insuficiencia hepática crónica agudizada (ACLF) o por descompensación aguda con riesgo de desarrollar ACLF.
    El estudio se divide en 4 períodos: período de selección, período activo del estudio que se subdivide en los períodos de tratamiento y de evaluación, y período de seguimiento a largo plazo de la seguridad.
    A.4.1Sponsor's protocol code numberHEP101
    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 SponsorPromethera Biosciences
    B.1.3.4CountryBelgium
    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 supportPromethera Biosciences
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPromethera Biosciences
    B.5.2Functional name of contact pointClinical Research Department
    B.5.3 Address:
    B.5.3.1Street AddressRue Granbonpré, 11
    B.5.3.2Town/ cityMont-Saint-Guibert
    B.5.3.3Post codeB-1435
    B.5.3.4CountryBelgium
    B.5.4Telephone number32 10 394300
    B.5.5Fax number32 10 394301
    B.5.6E-mailClinic@promethera.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 No
    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 nameHepaStem
    D.3.2Product code HHALPC
    D.3.4Pharmaceutical form Suspension for injection
    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 INNheterologous human adult liver-derived progenitor cells
    D.3.9.3Other descriptive nameHHALPC
    D.3.9.4EV Substance CodeSUB122824
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 50
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue engineered product (EMA/CAT/391889/2016) in the treatment of fibroinflammatory liver diseases.
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cirrhotic patients who are hospitalized for Acute on-
    chronic liver failure (ACLF) or Acute Decompensation at risk of
    developing ACLF. ACLF combines an acute deterioration of liver function
    in an individual with pre-existing chronic liver disease and extrahepatic
    organ failures characterized by high short-term mortality (30-40% at 28
    days). The development of ACLF is associated with exacerbated systemic
    inflammation that may indeed cause organ failures.
    Pacientes cirróticos que están hospitalizados por
    insuficiencia hepática crónica agudizada (ACLF) o Descompensación aguda con riesgo de desarrollar ACLF. ACLF combina un deterioro agudo de la función hepática en un individuo con enfermedad hepática crónica preexistente y extrahepática fallas orgánicas caracterizadas por alta mortalidad a corto plazo (30-40% a 28 dias). El desarrollo de ACLF se asocia con una exacerbación sistémica
    inflamación que de hecho puede causar fallas orgánicas.
    E.1.1.1Medical condition in easily understood language
    ACLF is an acute deterioration of liver function in an individual with cirrhosis and organ failures with systemic inflammation and high short term mortality.
    El ACLF es un deterioro agudo de la función hepática en un individuo con cirrosis y fallas orgánicas con inflamación sistémica y alta mortalidad a corto plazo.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008954
    E.1.2Term Chronic liver disease and cirrhosis
    E.1.2System Organ Class 100000004871
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10049844
    E.1.2Term Acute liver failure
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.
    Evaluar la seguridad de distintos regímenes posológicos de HepaStem en pacientes cirróticos con ACLF o con descompensación aguda y con riesgo de desarrollar ACLF, hasta el día 28 del período activo del estudio.
    E.2.2Secondary objectives of the trial
    • Preliminary efficacy:
    To evaluate clinical and biological efficacy parameters following HepaStem infusion up to Day 28, up to Month 3 and up to Year 1 post first HepaStem infusion.
    • Long term safety:
    To assess the safety of HepaStem up to Month 3 and Year 1 post first HepaStem infusion.
    • Eficacia preliminar:
    Evaluar los parámetros clínicos y biológicos de eficacia tras infusión con HepaStem hasta el día 28, hasta el mes 3 y hasta el año 1 tras la primera perfusión de HepaStem.
    • Seguridad a largo plazo:
    Evaluar la seguridad de HepaStem hasta el mes 3 y hasta el año 1 tras la primera perfusión de HepaStem.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult aged between 18 and 70 year old.
    2. Signed Informed Consent.
    N.B: In case of hepatic encephalopathy, if the patient is not able to fully understand the study based on the investigator's judgment, the Informed Consent must be signed by patient's legal representative according to local regulation, and by the patient, if possible, after encephalopathy improvement.
    3. Cirrhosis as diagnosed by (1) liver histology or (2) by clinical and imaging examination (may include fibroscan).
    4. Patient with Acute Decompensation of cirrhosis
    5. Serum total Bilirubin ≥ 6 mg/dL (≥100 umol/L)
    6. The INR measurement has to be : 1.2 ≤ INR < 2
    1. Pacientes adultos de entre 18 y 70 años de edad.
    2. Consentimiento informado firmado.
    NOTA: En caso de encefalopatía hepática, si según el criterio del investigador el paciente no es capaz de comprender plenamente el estudio, el consentimiento informado deberá ser firmado por el representante legal del paciente, de conformidad con la legislación local, y por el paciente, si es posible, una vez que haya mejorado su encefalopatía.
    3. La cirrosis se diagnostica mediante (1) histología hepática o (2) exploración clínica y pruebas de diagnóstico por imagen (puede incluir una elastografía hepática por impulsos).
    4. Paciente con descompensación aguda de la cirrosis
    5. Bilirrubina sérica total ≥ 6 mg/dl (≥ 100 µmol/l)
    6. El valor del INR debe ser: 1,2 ≤ INR < 2
    E.4Principal exclusion criteria
    1. Absence of portal vein flow as assessed by Doppler ultrasound or other exam.
    2. Recurrent or ongoing thrombotic events or patients considered with high risk of thrombosis at the time of infusion.
    Any thrombosis history should be discussed with the medical monitor before exclusion / inclusion in the study, in a case by case discussion.
    3. Gastrointestinal hemorrhage requiring blood transfusion unless controlled for more than 4 weeks prior to the first infusion.
    4. Variceal banding or sclerosis within 4 weeks before the infusion.
    5. Septic shock or non-controlled bacterial infection defined as persistent clinical signs of infection despite adequate antibiotic therapy for more than 48h.
    6. Clinical evidence of Aspergillus infection.
    7. Circulatory failure defined as treated with vasoconstrictors to maintain arterial pressure or inotropes to improve cardiac output. N.B:
    Use of terlipressin to control increased levels of creatinine is not an exclusion criterion.
    8. Respiratory disorders with pulse oximetry < 93% and related clinical signs, requiring or not mechanical ventilation.
    9. Coagulation disorders defined as :
    • INR ≥ 2
    • Fibrinogen < 100 mg/dL
    • Platelets < 50.000/mm3
    10. Major invasive procedure within 4 weeks before the infusion (within 1 week for minor invasive procedure such as e.g. transjugular liver biopsy). The proper healing of the puncture site should be verified by the investigator.
    11. Treatment with corticosteroids for acute liver disease less than 1 day before the start of the screening period.
    12. MELD score > 30.
    13. Previous organ transplantation and/or ongoing immunosuppressive treatments.
    14. Postoperative-decompensation following hepatectomy.
    15. Renal failure due to chronic kidney disease.
    16. Clinically significant left-right cardiac shunt.
    17. Known or suspected hypersensitivity or allergy to any of the components of the HepaStem Diluent (human albumin, heparin sodium and sodium bicarbonate) or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions.
    18. Malignancies, other than curatively treated skin cancer, unless a complete remission over 5 years.
    19. Refusal of abstinence from alcohol for at least 5 weeks from the study enrolment.
    20. Pregnancy (negative β-HCG test required) or women with childbearing potential who decline to use reliable contraceptive methods
    during the study.
    21. Participation to any other interventional study within the last 4 weeks.
    22. Any significant medical or social condition or disability that, in the Investigator's opinion, may warrant a specific treatment, or may interfere with the patient's optimal participation or compliance with the study procedures.
    1. Ausencia de flujo de la vena porta evaluado mediante ecografía Doppler o con otra prueba.
    2. Episodios trombóticos recurrentes o en curso, o pacientes que se consideren con alto riesgo de trombosis en el momento de la perfusión.
    Cualquier antecedente de trombosis deberá comentarse con el monitor clínico antes de la exclusión / inclusión en el estudio y se evaluará caso por caso.
    3. Hemorragia gastrointestinal que requiera una transfusión de sangre, salvo que se haya mantenido controlada durante más de cuatro semanas antes de la primera perfusión.
    4. Ligadura de varices o esclerosis durante las cuatro semanas previas a la perfusión.
    5. Choque séptico o infección bacteriana no controlada, definida como signos clínicos persistentes de infección pese a la administración de un tratamiento antibiótico adecuado durante más de 48 horas.
    6. Signos clínicos de infección por Aspergillus.
    7. Insuficiencia circulatoria, definida como la necesidad de tratamiento con vasoconstrictores para mantener la presión arterial o de inotrópicos para mejorar el gasto cardíaco. NOTA: El uso de terlipresina para controlar la concentración elevada de creatinina no se considera un criterio de exclusión.
    8. Trastornos respiratorios con pulsioximetría < 93 % y signos clínicos afines, requieran o no de ventilación mecánica.
    9. Trastornos de la coagulación, definidos como:
    • INR ≥ 2
    • Fibrinógeno < 100 mg/dl
    • Plaquetas < 50.000/mm3
    10. Procedimiento invasivo mayor durante las cuatro semanas previas a la perfusión (una semana en el caso de procedimientos invasivos menores como, por ejemplo, una biopsia transyugular hepática). El investigador deberá verificar que se haya curado correctamente el lugar de la punción.
    11. Tratamiento con corticosterioides debido a hepatopatía aguda menos de un día antes del inicio del periodo de selección.
    12. Puntuación MELD > 30.
    13. Pacientes sometidos previamente a un trasplante de órganos o que estén recibiendo tratamiento inmunodepresor.
    14. Descompensación posoperatoria tras una hepatectomía.
    15. Fallo renal debido a enfermedad renal crónica.
    16. Cortocircuito cardiaco izquierda-derecha clínicamente significativo.
    17. Alergia o hipersensibilidad, conocida o sospechada, a cualquiera de los componentes del diluyente de HepaStem (albúmina humana, heparina sódica y bicarbonato sódico) o antecedentes de alergias múltiples y/o graves a fármacos o alimentos, o historia de reacciones anafilácticas graves.
    18. Neoplasias malignas, al margen del cáncer de piel curado con tratamiento, salvo que se haya presentado remisión completa durante un mínimo de 5 años.
    19. Rechazo para abstenerse de consumir alcohol durante un mínimo de 5 semanas desde el momento de la inscripción en el estudio.
    20. Embarazo (se requiere un resultado negativo en prueba β-HCG) o mujeres potencialmente fértiles que se nieguen a utilizar métodos anticonceptivos fiables durante el estudio.
    21. Participación en cualquier otro estudio con intervención durante las cuatro últimas semanas.
    22. Cualquier afección o incapacidad social o médica significativa que, en opinión del investigador, pueda hacer necesaria la administración de un tratamiento específico o impedir una participación o cumplimiento óptimo de los procedimientos del estudio por parte del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Safety assessment:
    AEs reported up to Day 28 of the active study period, assessed for seriousness, severity, relationship to IMP and/or IMP administration procedure
    The AEs will include but will not be limited to clinically significant changes in clinical examinations, vital signs, laboratory tests, abdominal echography and Doppler up to Day 28.
    The relationship will be assessed based on investigator assessment, and in addition by SMC and the sponsor pharmacovigilance in line with the ATMP guideline.
    Valoración de la seguridad:
    Acontecimientos Adversos observados hasta el día 28 del período activo del estudio, evaluados en cuanto a su gravedad, intensidad y relación con el PEI y/o con su procedimiento de administración.
    Los AA incluirán, entre otros, los cambios clínicamente significativos en las exploraciones clínicas, las constantes vitales, las pruebas analíticas, la ecografía abdominal y Doppler hasta el día 28.
    La relación con el PEI será evaluada según el criterio del investigador, así como por el CVS y el departamento de farmacovigilancia del promotor, de acuerdo con las directrices sobre medicamentos de terapia avanzada (ATMP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse Events (AEs) reported up to Day 28 of the active study period.
    Acontecimientos Adversos (AA) observados hasta el día 28 del período activo del estudio.
    E.5.2Secondary end point(s)
    Clinical efficacy parameters will be assessed at Day 28, Month 3 and Year 1.
    • Mortality
    • Liver transplantation
    • Disease scoring: CLIF-OF score, CLIF-C ACLF score, CLIF ACLF grade, CLIF-C AD (pre-ACLF patients with Acute Decompensation), MELD score, Child Pugh score.

    Biological efficacy parameters will be assessed at Day 28, Month 3 and Year 1
    • Bilirubin, creatinine, INR and albumin values

    Long term safety follow-up
    • Adverse Events of Special Interest (AESIs) will be summarized at Month 3 and Year 1
    AESIs are SAE with fatal outcome, malignancies, AEs assessed by the investigator as possibly related to HepaStem, liver transplantation and outcome of liver transplantation New ACLF episode.
    Los parámetros clínicos de eficacia se evaluarán el día 28, al mes 3 y al año 1.
    • Mortalidad
    • Trasplante hepático
    • Puntuación de la enfermedad: puntuación CLIF-OF, puntuación CLIF-C ACLF, grado CLIF ACLF, CLIF-C AD (pacientes pre-ACLF con descompensación aguda), puntuación MELD, puntuación Child-Pugh.

    Los parámetros biológicos de eficacia se evaluarán el día 28, al mes 3 y al año 1.
    • Valores de bilirrubina, creatinina, INR y albúmina

    Seguimiento de la seguridad a largo plazo
    Los acontecimientos adversos de interés especial (AAIE) se resumirán al mes 3 y al año 1.
    AAIE son los AAG con resultado de muerte, las neoplasias malignas, los AA considerados por el investigador como posiblemente relacionados con la administración de HepaStem, el trasplante hepático y su resultado, así como los nuevos episodios de ACLF.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical efficacy parameters will be assessed at Day 28, Month 3 and Year 1
    Biological efficacy parameters will be assessed at Day 28, Month 3 and Year 1
    Long term safety follow-up:
    Adverse Events of Special Interest (AESIs) will be summarized at Month 3 and Year 1
    Los parámetros clínicos de eficacia se evaluarán el día 28, al mes 3 y al año 1.
    Los parámetros biológicos de eficacia se evaluarán el día 28, al mes 3 y al año 1.
    Seguimiento de la seguridad a largo plazo:
    Los acontecimientos adversos de interés especial (AAIE) se resumirán al mes 3 y al año 1.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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 No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    LVLP
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days4
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    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, IC must be signed by patient's legal representative according to local regulation, and by the patient, if possible, after encephalopathy improvement.
    En caso de encefalopatía hepática, el consentimiento informado debe estar firmada por el representante legal del paciente de acuerdo con la normativa local, y por el paciente, de ser posible, después de la mejora de la encefalopatía.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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
    ninguno
    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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-21
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