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    Summary
    EudraCT Number:2019-003051-11
    Sponsor's Protocol Code Number:HEP102
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-20
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003051-11
    A.3Full title of the trial
    Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) - DHELIVER
    Studio randomizzato, controllato con placebo, in doppio cieco, multicentrico di Fase IIb per valutare l'efficacia e la sicurezza di HepaStem in pazienti con insufficienza epatica acuta su cronica (ACLF) - DHELIVER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This trial will evaluate the safety and efficacy of HepaStem compared to placebo in patients with a cirrhotic liver condition called Acute on Chronic Liver Failure (ACLF). The study will be performed in multiple centers and in a double-blinded manner, meaning neither the patients nor the treating physicians know who is on placebo or the study drug.
    Questo studio valuterà la sicurezza e l'efficacia di HepaStem rispetto al placebo in pazienti con una condizione cirrotica del fegato chiamata Acute on Chronic Liver Failure (ACLF). Lo studio sarà condotto in più centri e in doppio cieco, il che significa che né i pazienti né i medici curanti sanno chi sta assumendo il placebo o il farmaco in studio.
    A.3.2Name or abbreviated title of the trial where available
    HEP102 - DHELIVER
    HEP102 - DHELIVER
    A.4.1Sponsor's protocol code numberHEP102
    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 Therapeutics SA
    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 Therapeutics SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPromethera Therapeutics SA
    B.5.2Functional name of contact pointWelcome desk
    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 number003210394300
    B.5.5Fax number003210394301
    B.5.6E-mailRegulatory@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 [HALPC]
    D.3.4Pharmaceutical form Dispersion 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.3.9.2Current sponsor codeHALPC
    D.3.9.4EV Substance CodeSUB199771
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    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 numberProdotto di Ingegneria Tissutale (EMA/CAT/391889/2016) nel trattamento delle malattie epatiche fibr-infiammatorie
    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 placeboSolution for infusion in administration system
    D.8.4Route of administration of the placeboIntravenous use
    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), 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 28days). The development of ACLF is associated with exacerbated systemic inflammation that may indeed cause organ failures.
    Pazienti cirrotici ospedalizzati per Insufficienza Epatica Acuta su Cronica (ACLF), ACLF combina, in un individuo affetto da malattia cirrotica epatica pre-esistente, un deterioramento delle funzioni epatiche ad un collasso di organi extraepatici, caratterizzato da un elevato tasso di mortalità a breve termine (30-40% in 28giorni). Lo sviluppo di ACLF è associato a un'infiammazione esacerbata sistemica che può causare il collasso degli organi.
    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.
    ACLF è un deterioramento acuto della funzionalità epatica in caso di malattia epatica cronica pre-esistente e insufficienza organica extraepatica caratterizzata da elevata mortalità a breve termine
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate the efficacy of 2 infusions (i.v.) of HepaStem at 1.0 million of cells/kg (7-day interval) on the overall survival proportion 90 days post-first infusion.
    L'obiettivo primario è dimostrare l'efficacia di 2 infusioni (e.v.) di HepaStem alla dose di 1.0 milione di cellule/kg (intervallo di 7 giorni) sulla percentuale di sopravvivenza complessiva 90 giorni dopo la prima infusione.
    E.2.2Secondary objectives of the trial
    1. Safety of 2 infusions (i.v.) of HepaStem at 1.0 million of cells/kg (7- day interval).
    2. Efficacy on the transplant-free survival proportion 90 days post-first infusion.
    3. Efficacy on the overall survival, transplant-free survival, and post-
    transplant survival proportion up to 1-year post-infusion.
    4. Efficacy on the liver function parameters, such as the MELD score and bilirubin levels, up to 1-year post-infusion.
    5. Efficacy on the inflammatory parameters, up to 1-year post-infusion.
    6. Efficacy on the transplant proportion, the duration of hospitalization in ICU, the duration of the overall hospitalization, the number of rehospitalization for ACLF, liver function, Quality of Live (QoL), and Investigator's and patient's opinion on the IMP.
    Exploratory: Efficacy on the survival proportion 90 days post-first infusion based on ACLF grading defined by IHDST NACSELD ACLF criteria.
    1. Sicurezza di 2 infusioni (e.v.) di HepaStem alla dose di 1.0 milione di cellule/kg (intervallo 7 giorni).
    2. Efficacia su percentuale di sopravvivenza libera da trapianto 90 giorni dopo la prima infusione.
    3. Efficacia su percentuale di sopravvivenza complessiva, sopravvivenza libera da trapianto e sopravvivenza post-trapianto fino a 1 anno post infusione.
    4. Efficacia su parametri di funzionalità epatica, come punteggio MELD e livelli di bilirubina, fino a 1 anno dopo l'infusione.
    5. Efficacia su parametri infiammatori fino a 1 anno dopo l'infusione.
    6. Efficacia su percentuale di trapianti, durata del ricovero in terapia intensiva e ricovero complessivo, numero di nuovi ricoveri per ACLF, funzionalità epatica, qualità della vita (QoL) e parere dello sperimentatore e paziente sul medicinale sperimentale (IMP).Esplorativo: Efficacia su percentuale di sopravvivenza 90 giorni dopo la prima infusione in base alla classificazione ACLF definita dai criteri per ACLF dell'IHDST NACSELD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must fulfil all of the following criteria in order to be eligible for trial enrolment:
    1. Adult aged 18 years and above.
    2. Initial diagnostic of ACLF, at the investigational site, maximum 3 days before signature of the ICF.
    3. Patient with Acute on Chronic Liver Failure Grade 1 or 2 according to the CLIF definition*.
    4. Bilirubin value =5 mg/dL.
    5. 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 a patient's legal or authorized representative according to local regulation, and by the patient, if possible, after encephalopathy improvement.
    * ACLF grading is based on the number of organ failure as defined per the CLIF-OF score (Arroyo et al. 2015); http://www.efclif.com/scientific-activity/score-calculators/clif-c-aclf
    Per essere idonei all'arruolamento nello studio, i pazienti devono soddisfare tutti i seguenti criteri:
    1. Adulto di età pari o superiore a 18 anni.
    2. Diagnosi iniziale di ACLF, presso il centro sperimentale, al massimo 3 giorni prima della firma del modulo di consenso informato.
    3. Paziente con insufficienza epatica acuta su cronica (Acute on Chronic
    Liver Failure, ACLF) di grado 1 o 2 secondo la definizione CLIF*.
    4. Valore della bilirubina =5 mg/dl.
    5. Firma del modulo di consenso informato.
    N.B.: in caso di encefalopatia epatica, se il paziente non è in grado di comprendere appieno lo studio secondo il giudizio dello sperimentatore, il modulo di consenso informato deve essere firmato dal rappresentante legale o autorizzato del paziente, secondo la normativa locale, e dal paziente stesso, se possibile, dopo il miglioramento dell'encefalopatia.
    * La classificazione dell'ACLF si basa sul numero di insufficienze d'organo, come definito in base al punteggio CLIF-OF (Arroyo et al.
    2015); http://www.efclif.com/scientific-activity/score-calculators/clif- c-aclf
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. ACLF grade 3.
    2. Active uncontrolled bleeding or patient with high risk of short term bleeding up to investigator's judgment.
    3. Model for End-Stage Liver Disease (MELD) score >35.
    4. Cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the screening and not considered stabilized by the investigator.
    5. Mechanical ventilation due to respiratory failure, except for hepatic encephalopathy.
    6. Inability to maintain mean BP >60 despite use of vasopressors.
    7. Patients receiving immunosuppressive drugs, except glucocorticoids.
    8. Thrombosis of portal vein.
    9. Underlying cirrhosis due to biliary disease (primary sclerosing cholangitis, primary biliary cholangitis…).
    10. Underlying cirrhosis due to autoimmune hepatitis.
    11. Coagulation disturbances defined as (Drolz et al. 2016; Nadim et al.
    2016):
    a. fibrinogen < 80 mg/dL
    b. platelets < 50 x 10³/mm³
    12. Uncontrolled bacterial infection upon judgment of the investigator.
    13. Proven or probable invasive aspergillosis (Gustot et al. 2014).
    14. Major invasive procedure within 2 weeks before the infusion. These are open surgeries (the proper healing of the scar should be verified by the investigator). N.B.: Liver biopsy (trans jugular or percutaneous), paracentesis, TIPS are not considered as a major invasive procedure.
    15. Previous organ transplantation and/or treatment with cells.
    16. Previous hepatectomy.
    17. Severe pulmonary arterial hypertension defined as mean pulmonary arterial pressure (MPAP) =45 mmHg.
    18. Hepatopulmonary syndrome.
    19. Known or suspected hypersensitivity or allergy to any of the components of the HepaStem Diluent (human albumin, heparin sodium and sodium bicarbonate, DMSO), bovine serum, or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions.
    20. Patients with active cancer or history of cancer unless adequately treated and/or in complete remission for five or more years.
    21. Hepatocellular carcinoma.
    22. On haemodialysis due to chronic kidney disease.
    23. Known infection with human immunodeficiency virus (HIV).
    24. Pregnancy (negative ß-HCG test required) and nursing women, or women with childbearing potential who decline to use highly effective contraception methods during the study. Authorized methods of contraception are listed in Section 10.14.2.
    25. Participation in any other interventional study within the last 4 weeks, or participation and/or under follow-up in another clinical trial.
    26. 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.
    27. Patients who are employees of the Sponsor or investigator, or otherwise dependent on them; Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    28. Accepted as High Urgency status patient by the organ allocation system (ex: Eurotransplant or equivalent)
    Depending on the reason of screening failures, a patient could be retested again (Visit 1 re-test) after consultation with the sponsor.
    Non saranno inclusi nello studio i pazienti che soddisfano uno o più dei seguenti criteri:
    1. ACLF di grado 3.
    2. Emorragia attiva non controllata o paziente ad alto rischio di emorragia a breve termine secondo il giudizio dello sperimentatore.
    3. Punteggio del Modello per la malattia epatica allo stadio terminale
    (Model for End-Stage Liver Disease, MELD) >35.
    4. Evento trombotico arterioso ad un arto, cerebrovascolare, miocardico o anamnesi di eventi cerebrovascolari sia trombotici che emorragici verificatisi nei 12 mesi precedenti allo screening e non ritenuti
    stabilizzati dallo sperimentatore.
    5. Ventilazione meccanica per insufficienza respiratoria, eccetto in caso di encefalopatia epatica.
    6. Incapacità di mantenere una pressione arteriosa media >60 nonostante l'uso di vasopressori.
    7. Pazienti che ricevono farmaci immunosoppressori, ad eccezione dei glucocorticoidi.
    8. Trombosi della vena porta.
    9. Cirrosi soggiacente dovuta a malattia biliare (colangite sclerosante primitiva, colangite biliare primitiva ecc.).
    10. Cirrosi soggiacente dovuta ad epatite autoimmune.
    11. Disturbi della coagulazione definiti come (Drolz et al. 2016; Nadim et al. 2016):
    a. fibrinogeno <80 mg/dl
    b. piastrine <50 x 10³/mm3
    12. Infezione batterica non controllata secondo il giudizio dello sperimentatore.
    13. Aspergillosi invasiva comprovata o probabile (Gustot et al. 2014).
    14. Procedura invasiva maggiore nelle 2 settimane precedenti all'infusione, ovvero interventi chirurgici (la corretta guarigione della cicatrice deve essere verificata dallo sperimentatore). N.B.: la biopsia epatica (transgiugulare o percutanea), la paracentesi e il TIPS non sono considerati procedure invasive maggiori.
    15. Precedente trapianto d'organo e/o trattamento con cellule.
    16. Epatectomia precedente.
    17. Ipertensione arteriosa polmonare grave, definita come pressione arteriosa polmonare media (PAPm) =45 mmHg.
    18. Sindrome epatopolmonare.
    19. Ipersensibilità o allergia nota o sospetta a uno qualsiasi dei componenti del diluente HepaStem (albumina umana, eparina sodica e bicarbonato di sodio, DMSO) o al siero bovino, oppure anamnesi di allergie multiple e/o gravi a farmaci o alimenti o anamnesi di reazioni anafilattiche gravi.
    20. Pazienti con cancro attivo o anamnesi di cancro, eccetto se adeguatamente trattato e/o in completa remissione da cinque anni o più.
    21. Carcinoma epatocellulare.
    22. Pazienti in emodialisi a causa di malattia renale cronica.
    23. Nota infezione da virus dell'immunodeficienza umana (HIV).
    24. Gravidanza (è richiesto un test ß-hCG negativo) e allattamento, oppure donne potenzialmente fertili che si rifiutano di usare metodi contraccettivi estremamente efficaci durante lo studio. I metodi contraccettivi autorizzati sono elencati nella Sezione 10.14.2.
    25. Partecipazione a qualsiasi altro studio interventistico nelle ultime 4 settimane oppure partecipazione ad un'altra sperimentazione clinica, anche se in fase di follow-up.
    26. Qualsiasi condizione medica o sociale o disabilità significativa che, secondo il parere dello sperimentatore, potrebbe giustificare un trattamento specifico o interferire con la partecipazione ottimale del paziente o la conformità alle procedure dello studio.
    27. Pazienti che sono dipendenti dello sponsor o dello sperimentatore o che dipendono da essi in altro modo; pazienti vincolati ad un istituto in virtù di un ordine emesso dall'autorità giudiziaria o amministrativa.
    28. Pazienti accettati come paziente in stato di alta urgenza dal sistema di allocazione degli organi (ad es: Eurotransplant o equivalente).
    A seconda del motivo del fallimento dello screening, un paziente potrebbe essere ritestato di nuovo (visita 1 ri-test) dopo aver consultato lo sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival proportion at 90 days post first infusion.
    Percentuale di sopravvivenza complessiva 90 giorni dopo la prima infusione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days post first infusion.
    90 giorni dopo la prima infusione.
    E.5.2Secondary end point(s)
    • Overall Survival proportion up to 1-year post first infusion.
    • Liver Transplant-free survival proportion at 90 days post first infusion.
    • Liver Transplant-free survival proportion up to 1-year post first infusion.
    • Liver transplantation-free proportion at 90 days post first infusion.
    • Liver transplantation-free proportion up to 1-year post infusion.
    • Post-liver transplant survival proportion up to 1-year post infusion.
    • Overall survival time.
    • Liver transplant-free time.
    • Liver transplant-free survival time.
    • West Haven, CLIF-OF, ACLF grade, CLIF-C ACLF score, CLIF-C AD, MELD
    score, Child Pugh score up to 1-year post first infusion.
    • Quantitative measurement of liver function parameters (bilirubin, AST, ALT, GGT, INR, albumin, ALP) up to 1 Year.
    • Quantitative measurement of kidney function parameters (creatinine, urea/BUN).
    • Quantitative measurement of inflammatory parameters (CRP, IL­6, IL­1ß, IL­8).
    • Quantitative measurement of leukocytes and neutrophils.
    • Change in QoL questionnaires (EQ-5D-5L and SF-36 QoL) up to 1 year.
    • The duration of hospitalization in ICU, the duration of the overall hospitalization, the number of rehospitalization for ACLF, and Investigator's and patient's opinion on the IMP.
    • Percentuale di sopravvivenza complessiva fino a 1 anno dopo la prima infusione.
    • Percentuale di sopravvivenza libera da trapianto di fegato 90 giorni dopo la prima infusione.
    • Percentuale di sopravvivenza libera da trapianto di fegato fino a 1
    anno dopo la prima infusione.
    • Percentuale di sopravvivenza libera da trapianto di fegato 90 giorni dopo la prima infusione.
    • Percentuale di sopravvivenza libera da trapianto di fegato fino a 1 anno dopo l'infusione.
    • Percentuale di sopravvivenza post-trapianto di fegato fino a 1 anno dopo l'infusione.
    • Tempo di sopravvivenza complessiva.
    • Tempo di sopravvivenza libera da trapianto di fegato.
    • Grado di ACLF e punteggi West Haven, CLIF-OF, CLIF-C ACLF, CLIF-C AD, MELD e Child Pugh fino a 1 anno dopo la prima infusione.
    • Misurazione quantitativa dei parametri di funzionalità epatica
    (bilirubina, AST, ALT, GGT, INR, albumina, ALP) fino a 1 anno.
    • Misurazione quantitativa dei parametri di funzionalità renale
    (creatinina, urea/BUN).
    • Misurazione quantitativa dei parametri infiammatori (CRP, IL­6, IL­1ß, IL­8).
    • Misurazione quantitativa dei leucociti e dei neutrofili.
    • Variazione nei questionari sulla QoL (EQ-5D-5L e SF-36 QoL) fino a 1 anno.
    • Durata del ricovero nel reparto di terapia intensiva, durata del ricovero complessivo, numero di nuovi ricoveri dovuti all'ACLF e parere dello sperimentatore e del paziente sull'IMP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 1 year post first infusion.
    fino a 1 anno dopo la prima infusione
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Georgia
    North Macedonia
    Serbia
    Turkey
    Estonia
    Austria
    Belarus
    Belgium
    Bulgaria
    Croatia
    Denmark
    Germany
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Portugal
    Romania
    Slovakia
    Slovenia
    Spain
    United Kingdom
    France
    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 years0
    E.8.9.1In the Member State concerned months34
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months34
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 93
    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, if the patient is not able to fully understand the study, the ICF must be signed by a patient's legal or authorized representative according to local regulation, and by the patient after improvement if possible.
    In caso di Encefalopatia epatica, se il paziente non è in grado di comprendere appieno lo studio, ICF è firmato da un rappresentante legale o autorizzato , in accordo con la legislazione locale, e dal paziente dopo suo miglioramento, se possibile.
    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 297
    F.4.2.2In the whole clinical trial 363
    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)
    At Month 12 study visit, patients who received at least 1 infusion of HepaStem will be invited to be included in the Patient Long term follow up registry study PROLONGSTEM.
    Alla Visita M12, i pazienti che hanno ricevuto almeno 1 infusione di HepaStem saranno invitati a partecipare ad uno studio di follow up a lungo termine sulla sicurezza (Studio PROLONGSTEM).
    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 Decision2020-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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