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    Summary
    EudraCT Number:2012-000633-39
    Sponsor's Protocol Code Number:FEC-TH
    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:2012-03-06
    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 number2012-000633-39
    A.3Full title of the trial
    Extracorporeal photopheresis in liver transplantation. Clinical trial phase I/II safety and efficacy in patients with progressive withdrawal of immunosuppression.
    FOTOAFERESIS EXTRACORPÓREA EN EL TRASPLANTE HEPÁTICO. ENSAYO CLINICO EN FASE I/II DE SEGURIDAD Y EFICACIA EN PACIENTES CON RETIRADA PROGRESIVA DE LA INMUNOSUPRESIÓN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extracorporeal photopheresis in liver transplantation. Clinical trial phase I/II safety and efficacy in patients with progressive withdrawal of immunosuppression.
    FOTOAFERESIS EXTRACORPÓREA EN EL TRASPLANTE HEPÁTICO. ENSAYO CLINICO EN FASE I/II DE SEGURIDAD Y EFICACIA EN PACIENTES CON RETIRADA PROGRESIVA DE LA INMUNOSUPRESIÓN
    A.3.2Name or abbreviated title of the trial where available
    FEC-TH
    FEC-TH
    A.4.1Sponsor's protocol code numberFEC-TH
    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 para la Formación e Investigación Sanitaria
    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 supportFundación para la Formación e Investigación Sanitaria
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para Formación e Investigación Sanitaria
    B.5.2Functional name of contact pointMacarena Quesada Rojas
    B.5.3 Address:
    B.5.3.1Street AddressC/Luis Fontes Pagan 9
    B.5.3.2Town/ cityMurcia
    B.5.3.3Post code30003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034968381292
    B.5.5Fax number0034968381289
    B.5.6E-mailmacarena.quesada@ffis.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 Uvadex 20microgramos /ml
    D.2.1.1.2Name of the Marketing Authorisation holderJohnson & Johnson Medical Ltd.
    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.3.4Pharmaceutical form Solution for blood fraction modification
    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.3.9.1CAS number 298-81-7
    D.3.9.3Other descriptive nameMETHOXSALEN
    D.3.9.4EV Substance CodeSUB14541MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 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
    Liver transplantation more than 2 years of evolution to complications of immunosuppression.
    Transplante hepático de más de 2 años de evolución con complicaciones derivadas de la inmunosupresión.
    E.1.1.1Medical condition in easily understood language
    Liver transplantation more than 2 years of evolution to complications of immunosuppression.
    Transplante hepático de más de 2 años de evolución con complicaciones derivadas de la inmunosupresión.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety of extracorporeal photopheresis in patients with longstanding liver transplantation under immunosuppression withdrawal complications from the use thereof.
    E.2.2Secondary objectives of the trial
    Evaluate the effect of extracorporeal photopheresis in the development of operational tolerance in liver transplant patients.

    Assess along the process of withdrawal of immunosuppression and FEC differences between patients who tolerate the graft and not in terms of:

    - Immunophenotype in peripheral blood of different Treg cell subsets, B Reg and dendritic cells.
    - Cytokines Th1/Th2/Th17.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Have been receiving liver transplant for over two years.
    - Treatment with immunosuppression that includes cyclosporine or tacrolimus.
    - Have a normal liver function in the last year
    - Not have suffered acute rejection in the last year and have no chronic rejection
    - Present any significant side effects of immunosuppressive medication (hypertension, creatinine greater than 1.7 mgDl, diabetes, morbid obesity, osteoporosis, hyperlipidemia, severe hirsutism, neurotoxicity, de novo malignancy, etc)
    - Etiology of underlying disease: alcoholic cirrhosis with or without hepatocellular carcinoma, metabolic diseases, familial amyloid polyneuropathy, biliary atresia, fulminant hepatitis non-A, not B, not C, cryptogenic cirrhosis and in general, non-autoimmune and viral causes.
    - Patients who offer sufficient guarantees of adherence to protocol
    ? Patients who give written informed consent to participate in the study.
    E.4Principal exclusion criteria
    - Underlying disease of the autoimmune (primary sclerosing cholangitis, autoimmune cirrhosis, primary biliary cirrhosis) and hepatocellular carcinoma in viral cirrhosis or autoimmune.
    - Patients with chronic rejection, or acute rejection in the last year
    - Patients with liver retransplantation
    - Inability to understand informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    - Absence of serious adverse events regarding possible, probable or definite with the procedure.
    - Rate of non-serious adverse events.
    - No signs of acute or chronic rejection.
    - Ausencia de acontecimientos adversos graves con relación posible , probable o segura con el procedimiento.
    - Tasa de acontecimientos adversos no graves.
    - No aparición de signos de rechazo agudo o crónico
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    - Clinical assessment:Liver function,levels of immunosuppressive,basic hematological parameters,metabolic parameters,renal function parameters.
    - Evaluation immune:Study of the evolution of subpopulations of peripheral blood mononuclear cells (T cells, B cells and dendritic cells),study of the evolution of cytokines in peripheral blood along the withdrawal of the SI (pg / ml).
    - Histological evaluation:Liver biopsies.
    - -Evaluación clínica: Función hepática, niveles de inmunosupresores, parametros hematologicos básicos, parámetros matabólicos, parametros de función renal.
    - Evaluación inmunológica:Estudio de la evolución de subpoblaciones de células mononucleares en sangre periférica ( células T, B y células dendríticas), Estudio de la evolución de citoquinas en sangre periférica a lo largo de las retirada de la IS (pg/ml).
    -Evaluación histológica:Biopsias hepáticas
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Clinical assessment:Liver function,levels of immunosuppressive,basic hematological parameters,metabolic parameters,renal function parameters.Evaluate:We Will take place on day 0, after 15 days and monthly up to 1 year.
    - Evaluation immune:Study of the evolution of subpopulations of peripheral blood mononuclear cells (T cells, B cells and dendritic cells),study of the evolution of cytokines in peripheral blood along the withdrawal of the SI (pg / ml).Evaluate:We Will take place on day 0, after 15 days and monthly up to 1 year.
    - Histological evaluation:Liver biopsies.Evaluate:There will be two months after withdrawal of immunosuppression and when clinically appropriate according to the protocol.
    -Evaluación clínica: Función hepática, niveles de inmunosupresores, parametros hematologicos básicos, parámetros matabólicos, parametros de función renal.Evaluación:Se realizará en la visita basal, a los 15 días y de forma mensual hasta 1 año.
    -Evaluación inmunológica:Estudio de la evolución de subpoblaciones de células mononucleares en sangre periférica ( células T, B y células dendríticas), Estudio de la evolución de citoquinas en sangre periférica a lo largo de las retirada de la IS (pg/ml).Evaluación:Se realizará en la visita basal, a los 15 días y de forma mensual hasta 1 año
    -Evaluación histológica:Biopsias hepáticas.Se realizarán dos meses después de la retirada de la inmunosupresión y cuando proceda clínicamente según el protocolo establecido.
    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) Yes
    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 No
    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 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
    Patients will have clinical and routine laboratory studies monthly for 1 year
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days30
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    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)
    After one month observe, we go on protocol of immunosuppression
    Tras un periodo de observación de un mes, se continuará el protocolo de disminución de inmunosupresores
    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 Decision2012-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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