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    Summary
    EudraCT Number:2010-022780-35
    Sponsor's Protocol Code Number:10-005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-022780-35
    A.3Full title of the trial
    A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy with UVADEX TM for the Treatment of Patients with Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD).
    Estudio controlado y aleatorizado de terapia con fotoaféresis extracorpórea (FEC) con UVADEX TM en pacientes con enfermedad injerto contra el huésped crónica (EICHc) moderada a severa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in patients with moderate to severe graft-versus-host disease, patinets randomly assigned to standard of care or to standard of care plus Extracorporeal (ECP) Therapy with UVADEX.
    Ensayo Clínico en pacientes con efermedad injerto contra huésped moderada a severa, pacientes asignados aleatoriamente al tratamiento habitual o al tratamiento habitual mas terapia extracorpórea (ECP) con UVADEX.
    A.4.1Sponsor's protocol code number10-005
    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 SponsorTHERAKOS, Inc.
    B.1.3.4CountryUnited States
    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 supportThearkos, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPAREXEL International Safety Center
    B.5.2Functional name of contact pointDr. Olga Fitsner
    B.5.3 Address:
    B.5.3.1Street AddressSokolovska 651/136a
    B.5.3.2Town/ cityPrague 8
    B.5.3.3Post code18600
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420233065203
    B.5.5Fax number+420233090416
    B.5.6E-mailPrague_Medical@parexel.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 Yes
    D.2.1.1.1Trade name UVADEX TM
    D.2.1.1.2Name of the Marketing Authorisation holderJohnson & Johnson Medical Ltd,trading as Therakos Europe
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/06/374
    D.3 Description of the IMP
    D.3.1Product namemethoxsalen
    D.3.4Pharmaceutical form Solution for blood fraction modification
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPExtracorporeal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmethoxsalen
    D.3.9.1CAS number 298-81-7
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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
    Chronic graft-versus-host disease (cGvHD).
    Enfermedad injerto contra huésped crónica (EICHc).
    E.1.1.1Medical condition in easily understood language
    Graft-versus-host disease is a complication of bone marrow
    transplantation in which immune cells in the transplanted marrow
    recognize the recipients as "foreign" and mount an immunological attack
    La EICHc es una complicación del transplante de médula en el que las
    células inmunes en la médula transplantada reconocen los receptores
    como "extranjeros" y preparan un ataque inmunológico.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10018651
    E.1.2Term Graft versus host disease
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of ECP (Extracorporeal photopheresis) as determined by the incremental improvement in cGvHD (chronic graft-versus-host disease) according to National Institutes of Healt (NIH) Consensus Response Criteria versus a control population.
    Comparar la eficacia de la fotoaféresis extracorpórea (FEC) en su determinación mediante el incremento de la mejoría de la EICHc según los criterios consensuados de respuesta de los National Institutes of Health (NIH) en comparación con una población de control.
    E.2.2Secondary objectives of the trial
    To assess changes in individual organ systems involved in cGvHD as
    assessed by NIH Consensus Criteria.
    To perform sensitivity analyses on the Criteria and correlate with the investigators' assessments.
    To correlate changes in the total skin score (TSS) instrument to the NIH
    Consensus Criteria in patients.
    To assess the efficacy of THERAKOS photopheresis systems (UVAR XTS
    and CELLEX) .
    To assess the QoL for both treatment arms.
    To assess the cumulative corticosteroids dose.
    To evaluate the safety of the 2 treatment arms.
    To capture and freeze blood and serum with the intention of assessing
    for potential biomarkers at the end of the study.
    -Evaluar los cambios en distintos sistemas orgánicos afectados en la
    EICHc en su evaluación mediante los criterios consensuados de respuesta de los NIH.
    -Efectuar análisis de sensibilidad de los criterios de respuesta y
    relacionarlos con las evaluaciones de los investigadores.
    -Relacionar los cambios en el cuestionario de puntuación cutánea total
    (TSS, Total Skin Score) con los criterios consensuados de respuesta de los NIH en pacientes con enfermedad cutánea.
    -Evaluar la eficacia de los sistemas de fotoaféresis de THERAKOS
    (UVAR® XTSTM y CELLEXTM).
    -Evaluar la dosis acumulada de corticosteroides.
    -Evaluar la calidad de vida en ambos grupos de tratamiento.
    -Evaluar la seguridad de los dos grupos de tratamiento.
    -Recoger y congelar muestras de sangre y suero con la intención de
    evaluar posibles biomarcadores al término del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are able to provide written informed consent.
    2. Meet NIH diagnostic criteria for initial onset of moderate to severe cGvHD with onset within 2 years of transplantation. Patients with prior acute cGvHD symptoms should be on a stable dose of <0.5 mg prednisone equivalent for at least 2 weeks prior to study entry.
    3. Age ? 18 years.
    4. Weight > 40 kg.
    5. Platelet count > 25,000/?L.
    6. Eastern Cooperative Oncology Group (ECOG) score of 0-2.
    7. Life expectancy of at least 3 months with no imminent relapse expected.
    8. Women of childbearing potential and all men must be using adequate birth control measures (e.g., abstinence,oral contraceptive, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the study.
    9. Women with childbearing potential must provide a negative pregnancy test within 10 days before study start.
    10. Patients must be able and willing to comply with all study procedures.
    1. Son capaces de otorgar su consentimiento informado por escrito.
    2. Cumplen los criterios diagnósticos de los NIH correspondientes a EICHc moderada a severa de presentación inicial, con comienzo en el plazo de los 2 años siguientes al trasplante. Los pacientes con síntomas de EICH aguda previa deben estar recibiendo una dosis estable de prednisona < 0,5 mg/kg al día, o equivalente, desde por lo menos 2 semanas antes de la entrada en el estudio.
    3. Edad 18 años.
    4. Peso > 40 kg.
    5. Recuento de plaquetas > 25.000/microlitro (incluso con soporte de plaquetas).
    6. Puntuación del ECOG (Eastern Cooperative Oncology Group) de 0-2 (véase el apéndice 2).
    7. Esperanza de vida de por lo menos 3 meses sin previsión de una recidiva inminente.
    8. Las mujeres potencialmente fértiles y todos los hombres deben estar utilizando métodos anticonceptivos adecuados (por ejemplo, abstinencia, anticonceptivos orales, dispositivo intrauterino, método de barrera con espermicida o esterilización quirúrgica) lo largo de todo el estudio.
    9. Las mujeres potencialmente fértiles deben presentar un resultado negativo de una prueba de embarazo en el plazo de los 10 días anteriores al comienzo del estudio.
    10. Los pacientes deben ser capaces de cumplir todos los procedimientos del estudio y estar dispuestos a hacerlo.
    E.4Principal exclusion criteria
    1. Corticosteroid intolerance, based on previous clinical experience.2. Previous treatment with > 0.5 mg/kg daily prednisone, or equivalent, for cGvHD for more than 72 hours prior
    to randomization.
    3. Evidence of known infection with human immunodeficiency virus (HIV) or active Hepatitis B.
    4. Requires treatment with budesonide.
    5. Expected to receive donor lymphocyte infusion (DLI).
    6. Uncontrolled infection requiring treatment at study entry.
    7. Known definite bronchiolitis obliterans (biopsy proven).
    8. Patients who have received biologic therapy as part of treatment for acute cGvHD or conditioning regimen
    which is expected to have a prolonged effect (e.g., alemtuzumab).
    9. Hypersensitivity or allergy to psoralen (methoxsalen).
    10. Hypersensitivity or allergy to both heparin and citrate products. (If hypersensitive or allergic to only one of
    these two products, exclusion does not apply).
    11. Inability to tolerate fluid changes associated with ECP (e.g., adequate renal, hepatic, pulmonary and cardiac
    function leading to enable patient to tolerate extracorporeal volume shifts associated with ECP).
    12. Presense of aphakia or photosensitive disease (systemic lupus erythromatosus, porphyrias, albinism, etc.).
    13. Women who are pregnant and/or lactating.
    14. Participation in another clinical trial for treatment of cGvHD within 28 days prior to randomization.
    1. Intolerancia a los corticosteroides, a juzgar por la experiencia clínica previa.
    2. Tratamiento previo con > 0,5 mg/kg al día de prednisona, o equivalente, para la EICHc durante más de 72 horas antes de la aleatorización.
    3. Signos de infección conocida por el virus de la inmunodeficiencia humana (VIH) o
    hepatitis B activa.
    4. Necesidad de tratamiento con budesonida.
    5. Previsión de recibir una infusión de linfocitos del donante.
    6. Infección no controlada que requiera tratamiento en la entrada en el estudio.
    7. Bronquiolitis obliterante confirmada conocida (demostrada por biopsia).
    8. Pacientes que hayan recibido una terapia biológica como parte del tratamiento de una EICH aguda o de un régimen de acondicionamiento, con previsión de un efecto prolongado (por ejemplo, alemtuzumab).
    9. Hipersensibilidad o alergia al psoraleno (metoxaleno).
    10. Hipersensibilidad o alergia a productos heparínicos y también a citratos. (No se excluirá a los pacientes con hipersensibilidad o alergia a uno solo de estos dos productos.)
    11. Incapacidad para tolerar las variaciones de volumen líquido asociadas a la FEC (por ejemplo, función renal, hepática, pulmonar y cardiaca que no permitan al paciente tolerar los cambios de volumen extracorpóreo asociados a la FEC).
    12. Presencia de afaquia o enfermedad fotosensible (lupus eritematoso sistémico, porfirias, albinismo, etc.).
    13. Mujeres embarazadas y/o en periodo de lactancia.
    14. Participación en otro ensayo clínico de tratamiento de la EICHc en el plazo de los 28 días anteriores a la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the Week 28 overall response (complete response [CR] or partial response [PR]) according to NIH Consensus Response Criteria.
    Safety endpoints for each patient will include vital signs, laboratory testing, including chemistry panel and complete blood count, and adverse event (AE) reporting, including AEs from active standard of care medication.
    El criterio de valoración principal será la respuesta global (respuesta completa [RC] o respuesta parcial [RP]) en la semana 28 conforme a los criterios consensuados de respuesta de los NIH.
    Los criterios de valoración de la seguridad de cada paciente incluirán las constantes vitales, las determinaciones de laboratorio (con bioquímica sérica y hemograma completo) y la comunicación de acontecimientos adversos (AE), incluidos los debidos a la medicación activa del tratamiento estándar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 28
    Semana 28
    E.5.2Secondary end point(s)
    Proportions of patients in each treatment group achieving response
    rates (CR or PR) by organ involvement through use of the NIH
    Consensus Criteria.
    Correlation between TSS and skin assessment using NIH Consensus
    Criteria.
    Sensitivity analyses on the (for example, considering alternative diagnoses and using one stage improvement response criteria)] and correlation with the investigators' assessments.
    QoL assessment.
    Efficacy data for THERAKOS UVAR XTS and CELLEX Photopheresis
    Systems.
    Efficacy assessment by baseline risk (high risk defined as patients with
    platelet count <100,000/?L at baseline) and severity of cGvHD.
    Cumulative dose of corticosteroids.
    Porcentajes de pacientes en cada grupo de tratamiento que alcancen una respuesta (RC o RP) por afectación orgánica a juzgar por los criterios consensuados de respuesta de los NIH.
    ? Correlación entre la TSS y la evaluación cutánea a juzgar por los criterios consensuados de respuesta de los NIH.
    ? Análisis de sensibilidad de los criterios de respuesta (por ejemplo, teniendo en cuenta diagnósticos alternativos y utilizando criterios de mejoría de la respuesta en una etapa) y relación con las evaluaciones de los investigadores.
    ? Evaluaciones de calidad de vida.
    ? Datos de eficacia de los sistemas de fotoaféresis UVAR® XTSTM y CELLEXTM de THERAKOS.
    ? Evaluación de la eficacia por riesgo basal (definido el alto riesgo como los pacientes con un recuento de plaquetas < 100.000/?l en el momento basal) y severidad de la EICHc.
    ? Dosis acumulada de corticosteroides.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 28 for all except the last one. The biomarker collect for all patients
    will end at week 28, but the testing will take afterwards.
    Semana 28 excepto para el último. La recogida de biomarcador para todos los pacientes terminará a la semana 28, pero el test se ralizará después.
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento estandar con corticoides con prednisona.
    Standard of Care trearment with corticosteroids at prednisone.
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Austria
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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
    The end of the study is defined as the date of the last visit of the last subject in the study.
    El fin del estudio está definido como la fecha de la última visita del último sujeto en el estudio.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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)
    No, it is not different from the expected normal treatment of this condition.
    No, no es diferente del tratamiento normal esperado para esta indicación.
    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 Decision2011-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-16
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