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    The EU Clinical Trials Register currently displays   39361   clinical trials with a EudraCT protocol, of which   6446   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-000376-41
    Sponsor's Protocol Code Number:VORIGENIPHARM
    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:2019-04-12
    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 number2019-000376-41
    A.3Full title of the trial
    Randomized and multicenter clinical trial to evaluate the effectiveness and efficiency of a voriconazole preemptive genotyping strategy in patients with risk of aspergillosis.
    Ensayo clínico aleatorizado y multicéntrico para evaluar la efectividad y la eficiencia de una estrategia de genotipado anticipado de voriconazol en pacientes con riesgo de aspergilosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to evaluate the effectivity and efficiency of preemptive genotyping before treatment with voriconazole
    Ensayo clínico para evaluar la efectividad y la eficiencia del genotipado anticipado antes del tratamiento con voriconazol
    A.4.1Sponsor's protocol code numberVORIGENIPHARM
    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 de Investigación del Hospital Universitario La Paz (FIBHULP)
    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 de Investigación del Hospital Universitario La Paz (FIBHULP)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación de Investigación del Hospital Universitario La Paz (FIBHULP)
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number912071466
    B.5.5Fax number912071466
    B.5.6E-mailebermejo.ucicec@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 Voriconazol
    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 Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVORICONAZOLE
    D.3.9.1CAS number 137234-62-9
    D.3.9.4EV Substance CodeSUB00087MIG
    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
    Invasive fungal disease in the hematologic patient.
    Enfermedad fúngica invasiva en el paciente hematológico.
    E.1.1.1Medical condition in easily understood language
    Infectious diseases by fungi, in patients with blood diseases.
    Enfermedades infecciosas por hongos, en pacientes con enfermedades de la sangre.
    E.1.1.2Therapeutic area Body processes [G] - Microbiological Phenomena [G06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10017528
    E.1.2Term Fungal infectious disorders
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10040054
    E.1.2Term Sepsis, bacteraemia, viraemia and fungaemia NEC
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10029355
    E.1.2Term Neutropenias
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076734
    E.1.2Term Chemotherapy induced neutropenia
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10061187
    E.1.2Term Haematopoietic neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10059041
    E.1.2Term Allogeneic peripheral haematopoietic stem cell transplant
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10059040
    E.1.2Term Autologous peripheral haematopoietic stem cell transplant
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluating the effectiveness and efficiency of a strategy of "anticipated genotyping" of voriconazole in the treatment and prophylaxis of fungal infections by aspergillus in haematological patients.
    Evaluación de la efectividad y la eficiencia de una estrategia de "genotipado anticipado" de voriconazol en el tratamiento y profilaxis de las infecciones fúngicas por aspergillus en pacientes hematológicos.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effectiveness of a strategy of "anticipated genotyping" of voriconazole to achieve adequate therapeutic levels in haematological patients with risk of fungal infection, in comparison with usual clinical practice.
    2. To evaluate the efficacy and safety of "anticipated genotyping" of voriconazole in haematological patients with risk of fungal infection, in comparison with usual clinical practice.
    3. Evaluate the efficiency of this strategy of "anticipated genotyping".
    1. Evaluar la efectividad de una estrategia de “genotipado anticipado” de voriconazol para conseguir niveles terapéuticos adecuados en pacientes hematológicos con riesgo de infección fúngica, en comparación con la práctica clínica habitual.
    2. Evaluar la eficacia y seguridad del “genotipado anticipado” de voriconazol en pacientes hematológicos con riesgo de infección fúngica, en comparación con la práctica clínica habitual.
    3. Evaluar la eficiencia de esta estrategia de “genotipado anticipado”.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient at risk of developing invasive aspergillosis, potential receipent of treatment or prophylaxis with voriconazole:
    A. Pediatric population: children who are going to receive a transplant of hematopoietic precursors (HSCT) and acute myeloid leukemias, as well as relapses of it.
    B. Adult population: patients diagnosed with acute leukemia, and those patients with expected prolonged neutropenia, secondary to hematological process and / or after specific treatment (aplastic anemia and variants, myelodysplastic syndrome, solid organ or bone marrow transplant, etc.), and those whose responsible clinician consider individually that they could present a risk of developing a fungal infection.
    2. Those who agree to participate in the study by signing informed consent (patients equal or over 18 years old)
    3. Subjects under 18 yeras old whose representative / legal guardian has voluntarily signed the informed consent.
    4. In the case of mature under 18 years subjects (12-17 years of age), in addition to the consent signed by the legal guardian, the consent of the subject will be obtained.
    1. Paciente con riesgo de desarrollar una aspergilosis invasiva que potencialmente puedan recibir tratamiento o profilaxis con voriconazol:
    A. Población pediátrica: niños que vayan a recibir un trasplante de precursores hematopoyéticos (TPH) y leucemias mieloides agudas, así como las recaídas de ésta.
    B. Población adulta: pacientes con diagnóstico de leucemias agudas, y aquellos pacientes con neutropenia prolongada esperada secundaria a proceso hematológico y/o tras tratamiento específico (anemia aplásica y variantes, síndrome mielodisplásico, trasplante de órgano sólido o médula, etc.) en el que el clínico responsable considere de forma individual que podrían presentar riesgo de desarrollar infección fúngica.
    2. Que acepte participar en el estudio firmando el consentimiento informado (pacientes mayores de edad)
    3. Sujetos menores cuyo representante/tutor legal haya firmado voluntariamente el consentimiento informado
    4. En el caso de menores maduros (12-17 años de edad), además del consentimiento firmado por el tutor legal, se obtendrá el asentimiento del menor.
    E.4Principal exclusion criteria
    1. Patients who for any reason should not be included in the study according to the criteria of the research team.
    2. Subjects who are not capable to understand the information sheet and unable to sign the informed consent.
    1. Pacientes que por cualquier motivo no deberían ser incluidos en el estudio según evaluación del equipo investigador.
    2. Sujetos que no sean capaces de comprender la hoja de información e incapaces de firmar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Serum voriconazole concentration within the therapeutic range start of treatment.
    Concentración sérica de voriconazol dentro del rango terapéutico
    E.5.1.1Timepoint(s) of evaluation of this end point
    5th day after the treatment start.
    En el 5º día del tratamiento.
    E.5.2Secondary end point(s)
    1. Therapeutic failure and adverse events. COMBINED VARIABLE THAT INCLUDE:
    - Change of antifungal or the association with another antifungal agent due to poor clinical-radiological evolution.
    - Need for antifungal change, due to suspicion or confirmation of invasive fungal disease.
    2. Adverse dose-related adverse events associated with treatment with voriconazole: visual disturbances (photopsias), skin reactions, neurotoxicity (confusion and visual hallucinations) and QTc lengthening.
    1. Fallo terapéutico y eventos adversos. VARIABLE COMBINADA QUE INCLUYE:
    - Cambio de antifúngicos o la asociación con otro agente antifúngico por mala evolución clínico-radiológica.
    - Necesidad de cambio antifúngico, debido a sospecha o confirmación de enfermedad fúngica invasiva.
    2. Eventos adversos relacionados con la dosis adversa asociados con el tratamiento con voriconazol: trastornos visuales (fotopsias), reacciones cutáneas, neurotoxicidad (confusión y alucinaciones visuales) y alargamiento de QTc.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Not applicable.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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
    Regimen de Dosificación según Ficha Técnica
    Product Labels Dosing Regime
    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 concerned3
    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
    Last visit of the last subject included.
    Última visita del último sujeto incluído.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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 Yes
    F.1.1Number of subjects for this age range: 73
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 51
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under 18 years old.
    Sujetos menores de 18 años.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state146
    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)
    none
    ninguno
    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 Decision2019-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-06
    P. End of Trial
    P.End of Trial StatusOngoing
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