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    Summary
    EudraCT Number:2016-001177-32
    Sponsor's Protocol Code Number:HEP101
    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:2017-03-17
    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 number2016-001177-32
    A.3Full title of the trial
    Multicenter Phase II Safety and Preliminary Efficacy Study of 2 dose regimens of HepaStem in Patients with Acute on Chronic Liver Failure.
    Etude Clinique multicentrique de phase II visant à évaluer la sécurité et l’efficacité préliminaire de 2 doses d’HepaStem chez des patients souffrant d’insuffisance hépatique aiguë sur une maladie chronique du foie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HEP101 is a clinical study designed for patients suffering from Acute on Chronic Liver Failure (ACLF). ACLF patients will receive 4 infusions of HepaStem within 2 weeks. They will be monitored at Day 28, Month 3 and Year 1 post first HepaStem infusion.
    La HEP101 est une étude conçue pour les patients souffrant d’insuffisance hépatique aiguë sur une maladie chronique du foie. Les patients recevront 4 infusions d’HepaStem en deux semaines. La sécurité d’HepaStem sera évaluée au jour 28, à 3 mois et à 1 an après la première perfusion.
    A.3.2Name or abbreviated title of the trial where available
    HEP101
    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 pointVinciane Wouters
    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 394311
    B.5.5Fax number32 10 394301
    B.5.6E-mailvinciane.wouters@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.3.9.2Current sponsor codeHHALPC
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberSomatic Cell Therapy Product (ref. EMA/CAT/243155/2011) in the treatment of urea cycle disorders.
    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
    Acute-on-chronic liver failure (ACLF) combines an acute deterioration of liver function in an individual with pre-existing chronic liver disease and extrahepatic organ failures. It is characterized by high short-term mortality (28-day mortality rate: 30-40%). Alcoholism and infection are the most frequent precipitating events. The development of ACLF is associated with exacerbated systemic inflammation that may indeed cause organ failures.
    L'ACLF se caractérise par une détérioration aiguë de la fonction du foie chez une personne souffrant d'une maladie chronique du foie associée à une insuffisance d'organes extra-hépatiques. L'ACLF est caractérisée par une mortalité élevée à court terme (30 à 40% de mortalité à 28 jours). L'alcoolisme et certaines infections en sont les déclencheurs les plus fréquents. Le développement de l'ACLF est associé à une inflammation systémique exacerbée qui peut provoquer de l'insuffisance d’organes.
    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 (28-day mortality rate: 30-40%).
    L’ACLF est une détérioration aiguë de la fonction hépatique chez une personne cirrhotique associant défaillance d’organes, inflammation systémique et mortalité élevée à court terme (30-40% à 28 jours)
    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
    The main objective of this trial is to assess the safety of 2 dose regimens of HepaStem in patients with ACLF up to Day 28 of the active study period.
    L’objectif principal de cette étude est d’évaluer la sécurité de 2 doses d’HepaStem chez des patients souffrant d’ACLF et ce jusqu’au jour 28 de la phase active de l’étude.
    E.2.2Secondary objectives of the trial
    • Preliminary efficacy
    To evaluate clinical and biological efficacy parameters following HepaStem infusion up to Day 28 and up to Month 3 and 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.
    • Efficacité préliminaire
    Évaluer les paramètres d’efficacité clinique et biologique après l’administration de la perfusion d’HepaStem, jusqu’au jour 28, à 3 mois et à 1 an après l’administration de la première perfusion d’HepaStem.

    • Sécurité à long terme :
    Évaluer la sécurité d’HepaStem jusqu’à 3 mois et 1 an après l’administration de la première perfusion d’HepaStem.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult aged between 18 and 70 year old.

    2. Informed Consent.
    N.B: In case of hepatic encephalopathy, 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. ACLF Grade 1 or ACLF Grade 2 with the following restrictions
    ACLF grade 1 eligible subset:
    - liver failure plus cerebral and/or kidney dysfunction
    - renal failure plus cerebral dysfunction
    - cerebral failure plus kidney dysfunction
    - coagulation failure plus cerebral and/or kidney dysfunction
    Or
    ACLF grade 2 eligible subset:
    Any combination of 2 organ failures including: liver failure, renal failure, cerebral failure, coagulation failure.
    1. Adulte âgé de 18 à 70 ans.

    2. Consentement éclairé.
    N.B. : En cas d'encéphalopathie hépatique, le formulaire de consentement doit être signé par le représentant légal du patient conformément à la réglementation locale et si possible, par le patient après une amélioration de l’encéphalopathie.

    3. Cirrhose dont le diagnostic est établi (1) par histologie hépatique ou (2) par l’examen clinique et l’imagerie (pouvant inclure une élastographie FibroScan).

    4. ACLF de grade 1 ou ACLF de grade 2, avec les restrictions suivantes:
    ACLF de grade 1, sous-groupe éligible :
    - insuffisance hépatique plus dysfonction cérébrale et/ou rénale
    - insuffisance rénale plus dysfonction cérébrale
    - défaillance cérébrale plus dysfonction rénale
    - insuffisance de la coagulation plus dysfonction cérébrale et/ou rénale
    Ou
    ACLF de grade 2, sous-groupe éligible :
    - L’association de la défaillance de 2 organes, notamment : insuffisance hépatique, insuffisance rénale, défaillance cérébrale, insuffisance de la coagulation.
    E.4Principal exclusion criteria
    1. Absence of portal vein flow as assessed by Doppler ultrasound or other exam.
    2. Known prothrombotic disease or medical history of thrombotic events.
    3. Gastrointestinal hemorrhage requiring blood transfusion unless controlled for more than 48h.
    4. Septic shock or non-controlled bacterial infection defined as persistent clinical signs of infection despite adequate antibiotic therapy for more than 48h.
    5. Clinical evidence of aspergilus infection.
    6. Circulatory failure defined as treated with vasoconstrictors to maintain arterial pressure or inotropes to improve cardiac output. N.B: Use of terlipressine to control increased levels of creatinine is not an exclusion criteria.
    7. Respiratory disordered with pulse oximetry < 93% and related clinical signs, requiring or not mechanical ventilation.
    8. Treatment with corticosteroids for acute liver disease within 2 weeks before HepaStem infusion.
    9. MELD score > 35.
    10. Previous organ transplantation and/or ongoing immunosuppressive treatments.
    11. Postoperative-decompensation following hepatectomy.
    12. Renal failure due to chronic kidney disease.
    13. Clinically significant left-right cardiac shunt.
    14. 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.
    15. Malignancies, other than curatively treated skin cancer, unless a complete remission over 5 years.
    16. Refusal of abstinence from alcohol for at least 5 weeks from the study enrolment.
    17. Pregnancy (negative β-HCG test required) or women with childbearing potential who decline to use reliable contraceptive methods during the study.
    18. Participation to any other interventional study within the last 4 weeks.
    19. 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. Absence de débit dans la veine porte, établie par échographie Doppler ou un autre examen.
    2. Maladie prothrombotique connue ou antécédents médicaux d’événements thrombotiques.
    3. Hémorragie gastro-intestinale nécessitant une transfusion sanguine, sauf si elle est maîtrisée pendant plus de 48 heures.
    4. Choc septique ou infection bactérienne non maîtrisée se manifestant par des signes cliniques d’infection persistants malgré une antibiothérapie adéquate pendant plus de 48 heures.
    5. Signes cliniques d’infection à Aspergillus.
    6. Insuffisance circulatoire nécessitant un traitement par vasoconstricteurs pour maintenir la pression artérielle ou un traitement par inotropes pour améliorer le débit cardiaque. N.B. : l’utilisation de terlipressine pour contrôler une augmentation des taux de créatinine ne constitue pas un critère d’exclusion.
    7. Affections respiratoires se caractérisant par une oxymétrie de pouls < 93 % et des signes cliniques associés, nécessitant ou non une ventilation mécanique.
    8. Traitement par corticostéroïdes en raison d’une pathologie hépatique aiguë survenue au cours des 2 semaines précédant la perfusion d’HepaStem.
    9. Score MELD > 35.
    10. Antécédents de greffe d’organe et/ou traitements immunosuppresseurs en cours.
    11. Décompensation postopératoire suite à une hépatectomie.
    12. Insuffisance rénale secondaire à une pathologie rénale chronique.
    13. Shunt cardiaque droite-gauche cliniquement significatif.
    14. Hypersensibilité ou allergie connue ou suspectée à l’un des composants du diluant d’HepaStem (albumine humaine, héparine sodique et bicarbonate de sodium), antécédents d’allergies multiples et/ou sévères à des médicaments ou à des aliments, ou antécédents de réactions anaphylactiques sévères.
    15. Malignités autres que le cancer cutané ayant été traité de manière curative, sauf en cas de rémission complète de plus de 5 ans.
    16. Refus de l’abstinence d’alcool pendant au moins les 5 semaines suivant l’inclusion dans l’étude.
    17. Grossesse (un test β-HCG négatif est requis) ou femmes en âge de procréer refusant d’utiliser des méthodes contraceptives efficaces pendant l’étude.
    18. Participation à une autre étude interventionnelle au cours des 4 dernières semaines.
    19. Toute situation médicale ou sociale significative ou toute inaptitude qui, selon l’avis de l’investigateur, est susceptible de justifier un traitement spécifique ou d’interférer avec la participation optimale du patient ou le respect des procédures liées à l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: Safety
    Adverse Events (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.
    Critère d’évaluation primaire : Sécurité
    • Les Effets Indésirables (EI) seront rapportés jusqu’au jour 28 de la phase active de l’étude, évalués en termes de gravité, de sévérité, de lien avec le médicament expérimental et/ou la procédure d’administration du médicament expérimental
    Les EI incluront mais ne se limiteront pas aux modifications cliniquement significatives constatées au niveau des examens cliniques, des signes vitaux, des tests biologiques, de l’échographie abdominale et du Doppler jusqu’au jour 28.
    La relation sera évaluée par l’investigateur, mais aussi par le CSS et le service de pharmacovigilance du promoteur conformément à la directive ATMP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse Events reported up to Day 28 of the active study period.
    Les effets indésirables seront rapportés jusqu’au jour 28 de la phase active de l’étude.
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    • Clinical efficacy parameters:
    - Mortality
    - Liver transplantation
    - Disease scoring: CLIF-OF score, CLIF-ACLF score, MELD score.
    • Biological efficacy parameters:
    - Bilirubin, creatinine, INR and albumin values
    • Long term safety follow-up
    - Adverse Events of Special Interest (AESIs)
    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
    • Paramètres d’efficacité clinique :
    - Mortalité
    - Transplantation hépatique
    - Score de la maladie : score CLIF-OF, score CLIF-ACLF, score MELD.
    • Paramètres d’efficacité biologique
    - Taux de bilirubine, taux de créatinine, INR et taux d’albumine
    • Suivi de sécurité à long terme
    - Un relevé des effets indésirables d’intérêt particulier (EIIP)
    Effets indésirables sévères (EIS) avec une issue fatale, malignités, EI évalués par l’investigateur comme potentiellement associés à HepaStem, transplantation hépatique et issue de transplantation hépatique
    - Un relevé des éventuels nouveaux épisodes d’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
    • New ACLF episode will be summarized at Month 3 and Year 1
    • Des paramètres d’efficacité clinique seront évalués au jour 28, à 3 mois et à 1 an
    • Des paramètres d’efficacité biologique seront évalués au jour 28, à 3 mois et à 1 an
    • Suivi de sécurité à long terme
    - Un relevé des effets indésirables d’intérêt particulier (EIIP) sera établi à 3 mois et à 1 an
    - Un relevé des éventuels nouveaux épisodes d’ACLF sera établi à 3 mois et à 1 an
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Dernier patient, dernière visite
    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 months
    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 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, Informed Consent must be signed by patient’s legal representative, and by the patient according to local regulation, if possible, after encephalopathy improvement.
    En cas d'encéphalopathie hépatique, le document sera signé par le représentant légal du patient et si possible par le patient, conformement à la réglementation locale, après une amélioration de l’encéphalopathie
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    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
    aucun
    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 Decision2018-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-21
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