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    Summary
    EudraCT Number:2020-000123-39
    Sponsor's Protocol Code Number:VITACTOH
    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:2020-02-28
    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 number2020-000123-39
    A.3Full title of the trial
    Phase II clinical trial, randomized, double blind, masked, controlled with physiological serum about the efficacy of intravenous administration of vitamin C during the anhepatic phase of liver transplantation to prevent the onset of reperfusion syndrome
    Ensayo clínico Fase II, aleatorizado, doble ciego, enmascarado, controlado con suero fisiológico sobre la eficacia de la administración intravenosa de vitamina C a dosis de 1,5 gr durante la fase anhepática del trasplante hepático para la prevención de la aparición del síndrome de reperfusión.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study about the use of intravenous Vitamin C for the prevention of Reperfusion Syndrome in Orthotopic Liver Transplantation from a cadaver donor.
    Estudio piloto sobre el empleo de Vitamina C intravenosa para la prevención del Síndrome de Reperfusión en el Trasplante Ortotópico de Hígado procedente de donante cadáver.
    A.3.2Name or abbreviated title of the trial where available
    VITACTOH
    VITACTOH
    A.4.1Sponsor's protocol code numberVITACTOH
    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 Investigación Biomédica Hospital Ramón y Cajal
    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 Investigación Biomédica Hospital Ramón y Cajal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Investigación Biomédica Hospital Ramón y Cajal
    B.5.2Functional name of contact pointAnabel Sánchez
    B.5.3 Address:
    B.5.3.1Street AddressCrta Colmenar Vieja km9.100
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491338825
    B.5.5Fax number+3491338825
    B.5.6E-mailanabelsanchez.hrc@gmail.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 Ácido Ascórbico Bayer 1.000 mg/5 ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HISPANIA, S.L
    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 injection
    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 INNAscorbic acid (D.C.I.)
    D.3.9.1CAS number 50-81-7
    D.3.9.2Current sponsor codeBAYER HISPANIA, S.L
    D.3.9.3Other descriptive nameASCORBIC ACID
    D.3.9.4EV Substance CodeSUB05579MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 0.9% physiological saline (100 ml)
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter, S.L
    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 injection
    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 INN0.9% physiological saline
    D.3.9.1CAS number 8026-10-6
    D.3.9.2Current sponsor codeBaxter, S.L
    D.3.9.3Other descriptive nameSODIUM CHLORIDE COMPOUND INJECTION
    D.3.9.4EV Substance CodeSUB15281MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Reperfusion syndrome
    Síndrome de reperfusión
    E.1.1.1Medical condition in easily understood language
    The reperfusion syndrome is defined as a 30% decrease in mean blood pressure within the first five minutes after the release of the portal clamp, lasted at least one minute.
    El síndrome de reperfusión se define como la disminución de un 30% de la presión arterial media dentro de los 5min primeros posteriores a la suelta del clamp portal, de al menos 1min de duración.
    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
    Incidence of the appearance of reperfusion syndrome in orthotopic liver transplantation from cadaver donor.
    Incidencia de la aparición de síndrome de reperfusión en el trasplante ortotópico de hígado procedente de donante cadáver.
    E.2.2Secondary objectives of the trial
    - Analyze Vitamin C levels before and after TH.
    - Analyze the levels of inflammatory markers before and after (12 hours after reperfusion) of TH (IL-1β, TNFα, IL-6, IL-8 and IFNγ). Compare the values between the treated group and the control group
    - Incidence of early dysfunction and primary graft failure
    - Length of stay in the ICU and hospital
    - Duration of Mechanical ventilation.
    - Doses and duration of administration of vasopressor and inotropic drugs from the moment of graft reperfusion
    - Incidence of postoperative renal failure
    - Graft and patient survival 30 days after transplant
    - Analizar los niveles de Vitamina C antes y después del TH.
    - Analizar los niveles de marcadores de inflamación antes y después (12 horas posreperfusión) del TH (IL-1β, TNFα, IL-6, IL-8 e IFNγ). Comparar los valores entre el grupo tratado y el grupo control
    - Incidencia de disfunción temprana y fallo primario del injerto
    - Tiempos de estancia en UCI y en el hospital
    - Tiempos de ventilación mecánica
    - Dosis y duración de la administración de fármacos vasopresores e inotropicos desde el momento de la reperfusión del injerto
    - Incidencia de fracaso renal postoperatorio
    - Supervivencia del injerto y del paciente a los 30 días del trasplante
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients, who after receiving the information about the design, the purposes of the study, the possible risks that may arise from it and that at any time they may deny their collaboration, give their informed consent in writing to take part in the study.
    • Be between 18 and 67 years of age
    • Understand the purpose of the study
    • Patients who are going to undergo HT from a cadaver donor and who have been included in the waiting list after the relevant evaluation of the patient selection committee.
    • Pregnancy test in urine performed in the 7 days prior to the start of treatment under study in premenopausal women is negative or <2 years after menopause
    Women of childbearing age (between menarche and menopause, defined as absence of menstruation for 12 consecutive months) and men with a fertile partner must commit to using an effective contraceptive method (such as surgical sterilization, double barrier method, contraceptives) oral or hormonal contraceptive implants).
    • Pacientes, que tras haber recibir información sobre el diseño, los fines del estudio, los posibles riesgos que de él pueden derivarse y de que en cualquier momento pueden denegar su colaboración, otorguen por escrito su consentimiento para participar en el estudio.
    • Ser mayor de 18 años y menor de 67.
    • Entender el propósito del estudio
    • Pacientes que vayan a ser sometidos a TH procedente de donante cadáver y que hayan sido incluidos en lista de espera tras la evaluación pertinente del comité de selección de pacientes.
    • Prueba de embarazo en orina negativa realizada en los 7 días anteriores al comienzo del tratamiento en estudio en mujeres premenopáusicas o < 2 años después de la menopausia
    Las mujeres en edad fértil (la comprendida entre menarquia y menopausia, definida como ausencia de menstruación durante 12 meses consecutivos) y los varones con pareja en edad fértil deben comprometerse a utilizar un método anticonceptivo eficaz (como esterilización quirúrgica, método de doble barrera, anticonceptivos orales o implantes hormonales contraceptivos).
    E.4Principal exclusion criteria
    • Pregnancy or planning to become pregnant during the course of the study. Lactation.
    • Known or suspected hypersensitivity to intravenous vitamin C or any of its excipients (methyl parahydroxybenzoate - E-218 -, propyl parahydroxybenzoate - E-216 -).
    • Nephrolithiasis or history of nephrolithiasis.
    • Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis).
    • Hyperoxaluria.
    • Hyperuricemia / gout (risk of uric acid deposits).
    • Hemochromatosis.
    • Sickle cell disease.
    • Being treated with deferoxamine, indinavir, cyanocobalamin (Vitamin B12), cyclosporine, disulfirate or iron.
    • Preoperative renal failure defined as serum creatinine greater than 1.2 mg / dl in women and 1.3 mg / dl in men.
    • Split type liver transplant.
    • Fulminant hepatitis as an indication of transplant.
    • Graft from living-related donor or donor in asystole
    • Embarazo o planificación de quedarse embarazada durante el transcurso del estudio. Lactancia
    • Hipersensibilidad conocida o sospechada a la vitamina C intravenosa o cualquiera de sus excipientes (parahidroxibenzoato de metilo - E-218 -, parahidroxibenzoato de propilo - E-216 -)
    • Nefrolitiasis o historia de nefrolitiasis
    • Déficit de glucosa-6-fosfato-deshidrogenasa (riesgo de hemólisis)
    • Hiperoxaluria
    • Hiperuricemia/gota (riesgo de depósitos de ácido úrico)
    • Hemocromatosis
    • Anemia de células falciformes
    • Encontrarse en tratamiento con deferoxamina, indinavir, cianocobalamina (Vitamina B12), ciclosporina, disulfiran o hierro.
    • Insuficiencia renal preoperatoria definida como Creatinina sérica mayor de 1,2 mg/dl en mujeres y 1,3 mg/dl en hombres
    • Trasplante hepático tipo “split”
    • Hepatitis fulminante como indicación de trasplante
    • Injerto procedente de donante vivo relacionado o de donante en asistolia
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients who develop reperfusion syndrome (SR) during the intervention.
    Porcentaje de pacientes que desarrollan el síndrome de reperfusión (SR) durante la intervención.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the surgery
    Durante la intervención quirúrgica
    E.5.2Secondary end point(s)
    1. Percentage of subjects with primary failure and early graft dysfunction to.
    a. Primary graft failure: Total failure of the liver graft function that requires the inclusion of the patient on the waiting list in a situation of Alert 0 for the realization of retransplantation, without which the patient's survival is not possible.
    b. Early graft dysfunction: Situation of graft dysfunction, which does not require its retransplantation. Patient survival is likely and possible without retransplantation, although morbidity will be greater than in the case of normofunctional grafts. Olthoff's criteria will be used for its definition (one criterion is sufficient)
    • Bilirubin greater than or equal to 10 mg / dL on day 7 postoperatively.
    • INR greater than or equal to 1.6 on day 7 of the postoperative period.
    • ALT or AST greater than 2000 IU / ml in the first 7 days of the postoperative period.
    2. Time spent in the ICU and hospital. Days of stay in the Surgical Intensive Care Unit (UCQ) and total days of hospital stay in the first admission since the transplant.
    3. Dose and duration of catecholamines from the time of reperfusion. Catecholamines used from the time of reperfusion of the graft, dose and duration of the graft (in micrograms / Kg / min and hours of duration)
    4. Duration of mechanical ventilation. Time to extubation of the patient since admission to the UCQ in hours.
    5. Vitamin C levels before and 12 hours after TH. The measurements will be made using high pressure liquid chromatography (HPLC) technique with ultraviolet detector in the Central Support Unit for Molecular Quantification and Characterization (UCA-CCM) of IRYCIS (Ramón y Cajal Hospital).
    6. Levels of pre and post-transplant inflammatory markers (IL-1β, TNFα, IL-6, IL-8 and IFNγ) using ELISA HS technique to be performed in the Immunology Service of Ramón y Cajal Hospital.
    7. Development of postoperative renal failure (AKI) in the first week. AKI is defined as an increase greater than or equal to 0.3 mg / dl over a period of 48 hours or a greater or equal increase of 50% of Creatinine over a period of 7 days or less.
    8. Need for postoperative renal replacement therapy during the first week: need to use any type of renal replacement therapy during the first seven days after transplantation regardless of the technique used, which will classify renal failure as AKI 3.
    9. Graft and patient survival 30 days after transplant
    1. Porcentaje de sujetos con fallo primario y disfunción temprana del injerto
    a. Fallo primarios del injerto: Fallo total de la función del injerto hepático que obliga a la inclusión del paciente en lista de espera en situación de Alerta 0 para la realización de retrasplante, sin el cuál la supervivencia del paciente no es posible.
    b. Disfunción temprana del injerto: Situación de disfunción del injerto, que no obliga a su retrasplante. La supervivencia del paciente es probable y posible sin retrasplante, aunque la morbilidad será mayor que en el caso de injertos normofuncionantes. Se empleará para su definición los criterios de Olthoff (un criterio es sufiente)
    • Bilirrubina mayor o igual a 10 mg/dL en el día 7 del postoperatorio.
    • INR mayor o igual a 1,6 en el día 7 del postoperatorio.
    • ALT o AST mayor a 2000 UI/ml en los 7 primeros días del postoperatorio.
    2. Tiempo de estancia en UCI y hospital. Días de estancia en la Unidad de Cuidados Intensivos Quirúrgicos (UCQ) y días totales de estancia en el hospital en el primer ingreso desde el trasplante.
    3. Dosis y duración de catecolaminas desde el momento de la reperfusión. Catecolaminas empleadas desde el momento de la reperfusión del injerto, dosis y duración de las mismas (en microgramos/Kg/min y horas de duración)
    4. Duración de ventilación mecánica. Tiempo hasta la extubación del paciente desde su ingreso en la UCQ en horas.
    5. Niveles de Vitamina C antes y 12 horas después del TH. Las mediciones se realizarán mediante técnica de cromatografía de líquidos de alta presión (HPLC) con detector ultravioleta en la Unidad Central de Apoyo de Cuantificación y Caracterización Molecular (UCA-CCM) del IRYCIS (Hospital Ramón y Cajal).
    6. Niveles de marcadores inflamatorios pre y post-trasplante (IL-1β, TNFα, IL-6, IL-8 e IFNγ) mediante técnica ELISA HS a realizar en el Servicio de Inmunología del Hospital Ramón y Cajal.
    7. Desarrollo de fracaso renal postoperatorio (AKI) en la primera semana. Se define AKI como un aumento mayor o igual a 0,3 mg/dl en un periodo de 48 horas o un aumento mayor o igual del 50% de la Creatinina en un periodo de 7 días o menos.
    8. Necesidad de terapia renal sustitutiva postoperatoria durante la primera semana: necesidad de emplear cualquier tipo de terapia renal sustitutiva durante los primeros siete días postrasplante independientemente de la técnica empleada, que clasificará el fracaso renal como AKI 3.
    9. Supervivencia del injerto y del paciente a los 30 días del trasplante
    E.5.2.1Timepoint(s) of evaluation of this end point
    For 30 days after transplant
    Durante 30 días después del trasplante
    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 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) 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    suero salino 0.9% (100ml)
    0.9% physiological saline (100 ml).
    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
    The study is consider completed when the last patient recruited performes the last scheduled visit. This visit will be 30 days after the liver transplant of the last patient recruited.
    El estudio finalizará cuando el último paciente reclutado realice la última visita del estudio. Esa visita será 30 días después de la realización del trasplante hepático del último paciente reclutado.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state70
    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)
    Not applicable. Care will be expected for that condition
    No aplica. Se seguirá tratando conforme práctica clínica
    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 Decision2020-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-01
    P. End of Trial
    P.End of Trial StatusOngoing
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