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   43857   clinical trials with a EudraCT protocol, of which   7284   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:2011-005372-42
    Sponsor's Protocol Code Number:HEPATOTRAS
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-01-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-005372-42
    A.3Full title of the trial
    Open-label, phase III, randomized, clinical trial to evaluate the efficacy of two different HBV vaccination schemes in patients with hepatic cirrhosis candidates to liver transplantation (HEPATOTRAS)
    Ensayo clínico de fase III, aleatorizado y abierto para evaluar la eficacia de dos pautas de vacunación diferentes frente al virus de la Hepatitis B (VHB) en pacientes cirróticos candidatos a trasplante de hígado (HEPATOTRAS).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study in humans to compare the efficacy of two different vaccination schemes against the hepatitis B virus, in patients with chronic liver disease that are candidates for transplantation.
    Estudio de investigación en humanos para comparar la eficacia de dos regímenes diferentes de vacunación frente al virus de la hepatitis B, en pacientes con enfermedad crónica del hígado que son candidatos a trasplante.
    A.4.1Sponsor's protocol code numberHEPATOTRAS
    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 SponsorFundación FISEVI
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinisterio de Sanidad y Política Social
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Virgen del Rocío
    B.5.2Functional name of contact pointUnidad de Coordinación de Ensayos
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Manuel Siurot s/n
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number34955013414
    B.5.5Fax number34954232992
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name HBVAXPRO 40 mcg
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR MSD SNC
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHBVAXPRO 40 micrograms
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHepatitis B virus surface antigen, recombinant
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN (RDNA)
    D.3.9.4EV Substance CodeSUB20082
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    HBV inmunization in patients with cirrhosis candidates for liver transplantation.
    Inmunización frente a VHB en pacientes con cirrosis hepática candidatos a trasplante de hígado.
    E.1.1.1Medical condition in easily understood language
    Efficacy of vaccination against hepatitis B virus (HBV) in patients with chronic liver disease candidates for organ trasplantation.
    Eficacia de la vacunación frente al virus de la hepatitis B en pacientes con enfermedad crónica del higado candidatos a trasplante.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10054130
    E.1.2Term Hepatitis B immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061890
    E.1.2Term Organ transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019641
    E.1.2Term Hepatic cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the response rate obtained with two different vaccionation schemes against HBV in cirrhotic patients potential candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 UI/ml) after three intramuscular doses of 40 ?g at 0, 1 and 2 months.
    Comparar la tasa de respuesta obtenida con dos pautas de vacunación diferentes frente al VHB en pacientes cirróticos candidatos potenciales a trasplante de hígado, que no han obtenido seroconversión (anti-HBs < 10 UI/ml) tras tres dosis de 40 ?g intramusculares (IM) a los 0,1, y 2 meses.
    E.2.2Secondary objectives of the trial
    To evaluate the association of immunogenicity of two vaccination procedures with clinical variables: age, sex, tobacco, diabetes, weight, body mass index / obesity, presence of anti-HBc positive, etiological factors and severity (Child Pugh stage, index MELD) in cirrhosis.
    Valorar la asociación de la inmunogenicidad de ambas pautas vacunales con variables clínicas: edad, sexo, tabaco, diabetes, peso, índice de masa corporal/obesidad, presencia de anti-HBc positivo, factores etiológicos y severidad (estadio de Child Pugh, índice de MELD) de la cirrosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cirrhotic patients over 18 years old, potential candidates for liver transplantation with an estimated wait time of more than 6 months, with indication to HBV vaccionation (HBsAg negative and anti-HBs negative), who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 ?g at 0, 1 and 2 months, and who have given their consent to participate in the study.
    Pacientes cirróticos mayores de 18 años potenciales candidatos a trasplante de hígado con un tiempo estimado de espera de más de 6 meses, con indicación de vacunación frente al VHB (HBsAg negativo y anti-HBs negativo), que no obtengan respuesta tras un primer ciclo de vacunación de tres dosis de 40 ?g IM a los 0, 1 y 2 meses, y que hayan prestado su conformidad para participar en el estudio.
    E.4Principal exclusion criteria
    Absolute contraindication to HBV vaccine.
    Medical history of allergy to any component of the vaccine.
    Chronic renal failure on hemodialysis.
    Presence of antibodies against Human Immunodeficiency Virus.
    Patients with seroconversion (anti-HBs ? 10 IU /ml) after the first three doses of vaccine.
    Lack of consent to participate in the study.
    Contraindicación absoluta a la vacuna VHB.
    Antecedente de alergia a algún componente de la vacuna.
    Insuficiencia renal crónica en hemodiálisis.
    Presencia de anticuerpos frente al virus de la inmunodeficiencia humana.
    Pacientes con seroconversión (anti-HBs ? 10 UI/ml) tras las tres primeras dosis de vacuna.
    Ausencia de consentimiento para participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Post-vaccination serological response measured by the titre of anti-HBs and the response rate (? 10 IU / ml).
    Respuesta serológica post-vacunal que se medirá mediante el título de anti-HBs y la tasa de respuesta (?10 UI/ml).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 35 ± 5 days after administration of the first cycle of vaccination (0, 1 and 2 months). In order to identify non-responders.
    At 35 ± 5 days after administration of the 4th dose at month 6 (Standard scheme).
    At 35 ± 5 days after administration of the second cycle of vaccination (0, 1 and 2 months) (Experimental scheme).

    Serum extraction will coincide as much as possible
    with other blood determinations to control patient's disease.
    A los 35 ± 5 días de haber administrado el primer ciclo de vacunación (0, 1 y 2 meses). Servirá para identificar a los pacientes no respondedores.
    A los 35 ± 5 días tras la administración de la 4ª dosis a los 6 meses (pauta estándar).
    A los 35 ± 5 días tras haber administrado el segundo ciclo de vacunación (0, 1 y 2 meses) (pauta experimental).

    La extracción de suero se hará coincidir en lo posible
    con otras determinaciones sanguíneas de control de la enfermedad.
    E.5.2Secondary end point(s)
    Association of serological response to HBV vaccionation to other clinical variables: age, sex, etiology and severity of cirrhosis (according to Child Pugh score, MELD index),diabetes, tobacco, weight, index of body mass/obesity, presence of anti-HBc positive, local and general adverse effects of the vaccine.
    Asociación de la respuesta serológica a la vacuna VHB a otras variables clínicas: edad, sexo, etiología y severidad de la cirrosis (Estadío Child Pugh, indice MELD), diabetes, tabaco, peso, indice de masa corporal/obesidad, presencia de anti-HBc positivo, efectos adversos locales y generales de la vacuna.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical variables (age, weight, etiology and severity of cirrhosis, diabetes, snuff, weight, body mass index, obesity, presence of anti-HBc positive) will be collected at baseline visit.

    Local and general adverse effects of the vaccine will be recorded during the patients follow-up visits.
    Las variables clínicas (edad, peso, etiología y severidad de la cirrosis, diabetes, tabaco, peso, indice de masa corporal, obesidad, presencia de anti-HBc positivo) serán recogidas al inicio del estudio.

    Los efectos adversos locales y generales de la vacuna se registrarán durante las visitas de seguimiento del paciente.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Mismo IMP usado como control, esquema de vacunación estándar
    Same IMP as control, standard vaccination scheme
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    UVUP (ultima visita, último paciente incluido)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 118
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state118
    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)
    Expected normal treatment of that condition
    Tratamiento normal esperado para dicha condición médica
    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 Decision2012-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Thu Apr 25 02:39:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA