Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-003051-11
    Sponsor's Protocol Code Number:HEP102
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-01-13
    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 ConcernedPortugal - INFARMED
    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
    Estudo randomizado, controlado por placebo, duplo-cego, multicêntrico de Fase IIb para avaliar a eficácia e segurança de HepaStem em doentes com insuficiência hepática crónica aguda (ACLF)
    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.
    Este ensaio vai avaliar a segurança e eficácia de HepaStem comparado com placebo em doentes com cirrose hepática designada insuficiência hepática crónica aguda (ACLF). O estudo será realizado em vários centros e em dupla ocultação, ou seja, nem os doentes nem os médicos sabem quem está a receber o placebo ou o medicamento do estudo.
    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 S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPromethera Therapeutics S.A.
    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 number3210394300
    B.5.5Fax number3210394301
    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.3.8INN - Proposed INNHuman Allogenic liver-derived Progenitor cells
    D.3.9.2Current sponsor codeHALPC
    D.3.9.3Other descriptive nameHuman allogenic liver-derived progenitor cells
    D.3.9.4EV Substance CodeSUB199771
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    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.
    Em doentes com cirrose hospitalizados por insuficiência hepática crónica aguda, a ACLF combina uma deterioração aguda da função hepática num indivíduo com doença hepática crónica preexistente e falência extra-hepática de órgãos caracterizada por elevada mortalidade a curto prazo (30-40% em 28 dias). O desenvolvimento da ACLF está associado à inflamação sistémica exacerbada que pode realmente causar falência de órgãos.
    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.
    A ACLF é uma deterioração aguda da função hepática num indivíduo com cirrose e falência de órgãos com inflamação sistémica e elevada mortalidade a curto prazo.
    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.
    O objectivo primário é demonstrar a eficácia de 2 perfusões (IV) de HepaStem a 1,0 milhão de células/kg (intervalo de 7 dias) na proporção de sobrevida global 90 dias após a primeira perfusão.
    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 posttransplant 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. Segurança de 2 perfusões (IV) de HepaStem a 1,0 milhão de células/kg (intervalo de 7 dias).
    2. Eficácia na proporção de sobrevida livre de transplante 90 dias após a primeira perfusão.
    3. Eficácia na proporção de sobrevida global, sobrevida livre de transplante e sobrevida após transplante até 1 ano após a perfusão.
    4. Eficácia nos parâmetros da função hepática, como a pontuação MELD e os níveis de bilirrubina, até 1 ano após a perfusão.
    5. Eficácia nos parâmetros inflamatórios, até 1 ano após a perfusão.
    6. Eficácia na proporção de transplantes, na duração da hospitalização na UCI, na duração da hospitalização global, no número de novas hospitalizações devido a ACLF, função hepática, Qualidade de vida (QdV) e opinião do Investigador e dos doentes sobre o ME.
    Exploratórios: Eficácia na proporção de sobrevida 90 dias após a primeira perfusão com base na classificação da ACLF definida pelos critérios de ACLF do IHDST e pelos critérios de ACLF do 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
    Os doentes devem cumprir todos os critérios seguintes para serem elegíveis para a inclusão no estudo:
    1. Adulto com 18 anos ou mais.
    2. Diagnóstico inicial de ACLF, no centro de investigação, no máximo 3 dias antes da assinatura do FCI.
    3. Doente com agudização da insuficiência hepática crónica de grau 1 ou 2 de acordo com a definição CLIF*.
    4. Valor de bilirrubina ≥5 mg/dl.
    5. Consentimento informado assinado.
    Nota: Em caso de encefalopatia hepática, caso o doente não tenha capacidade para compreender totalmente o estudo, com base no parecer do Investigador, o Consentimento informado deve ser assinado por um representante legal ou autorizado do doente, de acordo com a regulamentação local, e pelo doente, se possível, após melhoria da encefalopatia.
    * A classificação da ACLF baseia-se no número de falências orgânicas conforme definido pela pontuação de 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 β-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.
    Os doentes que apresentarem qualquer um dos seguintes itens não serão incluídos no estudo:
    1. ACLF de grau 3.
    2. Hemorragia não controlada activa ou doente com alto risco de hemorragia a curto prazo segundo o parecer do Investigador.
    3. Modelo de Pontuação na doença hepática em estadio terminal (Model for End-Stage Liver Disease, MELD) >35.
    4. Evento cerebrovascular, miocárdico, trombótico arterial dos membros ou história de eventos cerebrovasculares trombóticos e hemorrágicos no período de 12 meses antes da selecção e não considerados estabilizados pelo Investigador.
    5. Ventilação mecânica devido a insuficiência respiratória, com excepção de encefalopatia hepática.
    6. Incapacidade de manter a TA média >60 apesar da utilização de vasopressores.
    7. Doentes que tomam medicamentos imunossupressores, excepto glucocorticóides.
    8. Trombose da veia porta.
    9. Cirrose subjacente devido a doença biliar (colangite esclerosante primária, colangite biliar primária, etc.).
    10. Cirrose subjacente devido a hepatite auto-imune.
    11. Distúrbios da coagulação definidos como (Drolz et al. 2016; Nadim et al. 2016):
    a. fibrinogénio <80 mg/dl
    b. plaquetas <50 x 10³/mm3
    12. Infecção bacteriana não controlada segundo parecer do Investigador.
    13. Aspergilose invasiva comprovada ou provável (Gustot et al. 2014).
    14. Procedimento invasivo significativo no período de 2 semanas antes da perfusão. Estas são cirurgias abertas (a cicatrização adequada da cicatriz deve ser verificada pelo Investigador). Nota: A biópsia ao fígado (transjugular ou percutânea), a paracentese e a TIPS não são considerados como procedimentos invasivos significativos.
    15. Transplante de órgão prévio e/ou tratamento com células.
    16. Hepatectomia prévia.
    17. Hipertensão arterial pulmonar grave definida como uma tensão arterial pulmonar (MPAP) média ≥45 mmHg.
    18. Síndroma hepatopulmonar.
    19. Hipersensibilidade ou alergia conhecida ou suspeita a qualquer dos componentes do diluente do HepaStem (albumina humana, heparina sódica e bicarbonato de sódio, DMSO), soro de bovino ou história de alergias múltiplas e/ou graves a medicamentos ou alimentos ou história de reacções anafilácticas graves.
    20. Doentes com cancro activo ou história de cancro, excepto se tratado adequadamente e/ou em remissão completa há cinco anos ou mais.
    21. Carcinoma hepatocelular.
    22. Em hemodiálise devido a doença renal crónica.
    23. Infecção conhecida por vírus da imunodeficiência humana (VIH).
    24. Gravidez (teste β-HCG negativo obrigatório) e mulheres a amamentar ou mulheres que possam engravidar que recusem utilizar métodos de contracepção altamente eficazes durante o estudo. Os métodos de contracepção autorizados são indicados na Secção 10.14.2.
    25. Participação em qualquer outro estudo intervencional nas últimas 4 semanas ou participação e/ou em seguimento noutro estudo clínico.
    26. Qualquer doença ou incapacidade médica ou social significativa que, na opinião do Investigador, possa exigir um tratamento específico ou possa interferir com a participação ou o cumprimento optimizado dos procedimentos do estudo por parte do doente.
    27. Doentes que sejam funcionários do Promotor ou do Investigador ou que dependam dos mesmos de outra forma; Doentes institucionalizados por ordem das autoridades judiciais ou administrativas
    28. Doente aceite com estado de urgência elevado pelo sistema de atribuição de órgãos (por ex.: Eurotransplant ou equivalente)
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival proportion at 90 days post first infusion
    Proporção de sobrevida global 90 dias após a primeira perfusão
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days post first infusion
    90 dias após a primeira perfusão
    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,
    IL1β, 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.
    • Proporção de sobrevida global até 1 ano após a primeira perfusão.
    • Proporção de sobrevida global sem transplante hepático 90 dias após a primeira perfusão.
    • Proporção de sobrevida global sem transplante hepático até 1 ano após a primeira perfusão.
    • Transplante hepático 90 dias após a primeira perfusão.
    • Transplante hepático até 1 ano após a perfusão.
    • Proporção de sobrevida após transplante hepático até 1 ano após a perfusão.
    • Tempo de sobrevida global.
    • Tempo sem transplante hepático.
    • Pontuação de West Haven, CLIF-OF, grau de ACLF, pontuação de CLIF-C ACLF, CLIF-C AD, pontuação do MELD, pontuação de Child Pugh até 1 ano após a primeira perfusão.
    • Medição quantitativa dos parâmetros da função hepática (bilirrubina, AST, ALT, GGT, INR, albumina, FA) até 1 ano.
    • Medição quantitativa dos parâmetros da função renal (creatinina, ureia/BUN).
    • Medição quantitativa dos parâmetros inflamatórios (PCR, IL­6, IL­1β, IL­8).
    • Medição quantitativa de leucócitos e neutrófilos.
    • Alteração nos questionários de QdV (QdV EQ-5D-5L e SF-36) até 1 ano.
    • A duração da hospitalização na UCI, a duração da hospitalização global, o número de novas hospitalizações devido a ACLF e a opinião do Investigador e dos doentes sobre o ME.
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 1 year post first infusion.
    até 1 ano após a primeira perfusão
    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 concerned8
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLP
    UVUD
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months34
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months34
    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: 290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 73
    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.
    No caso de encefalopatia hepática, se o doente não conseguir entender completamente o estudo, o FCI deve ser assinado pelo representante legal ou autorizado do doente, de acordo com a regulamentação local, e pelo doente após melhoria, se possível.
    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.
    Na visita do mês 12 do estudo, os doentes que receberam pelo menos 1 perfusão de HepaStem serão convidados a serem incluídos no estudo de registo de acompanhamento do doente a longo prazo, 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 Decision2020-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 16:02:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA