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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2009-017467-42
    Sponsor's Protocol Code Number:CHAGASAZOL01
    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:2010-02-19
    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 number2009-017467-42
    A.3Full title of the trial
    - ENSAYO CLÍNICO DE FASE II, ALEATORIZADO Y ABIERTO PARA EL TRATAMIENTO ETIOLÓGICO DE LA ENFERMEDAD DE CHAGAS CRÓNICA CON POSACONAZOL y BENZNIDAZOL

    - PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE.
    A.4.1Sponsor's protocol code numberCHAGASAZOL01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorServicio Enfermedades Infecciosas
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    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 LAFEPE BENZNIDAZOL
    D.2.1.1.2Name of the Marketing Authorisation holderLAFEPE
    D.2.1.2Country which granted the Marketing AuthorisationBrazil
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBenznidazol
    D.3.9.1CAS number 22994-85-0
    D.3.9.3Other descriptive nameLAFEPE BENZNIDAZOL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 NOXAFIL 40 mg/ml suspensión oral
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING PLOUGH EUROPE
    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 Oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOSACONAZOL
    D.3.9.3Other descriptive namePOSACONAZOL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Tratamiento de la Enfermedad Chagas en fase crónica, forma indeterminada y sintomática
    Chagas Disease treatment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10008384
    E.1.2Term Chagas' disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la curación parasitológica de los pacientes igual o mayores de 18 años con enfermedad de Chagas en fase crónica tanto en su forma indeterminada como en las sintomáticas, mediante la negativización de la carga parasitaria medida con PCR a tiempo real en sangre periférica a los 10 meses de finalizar el tratamiento con posaconazol o benznidazol
    E.2.2Secondary objectives of the trial
    1. Evaluar la curación parasitológica mantenida en la enfermedad de Chagas en fase crónica tras diferentes esquemas terapéuticos, según la negativización de la carga parasitaria medida con PCR a tiempo real en sangre periférica al finalizar el tratamiento y las 8, 16, 24 y 40 semanas de la finalización del tratamiento.
    2. Evaluar la respuesta serológica de los pacientes con enfermedad de Chagas en fase crónica tanto tratados con cada uno de los diferentes esquemas terapéuticos, mediante curvas de tendencia de DO de los métodos de ELISA.
    3. Valorar tolerabilidad y seguridad de posaconazol a dos dosis diferentes como tratamiento de la enfermedad de Chagas en fase crónica.
    4. Obtener curvas de farmacocinética de posaconazol tras dos pautas diferentes de dosificación en población latinoamericana con enfermedad de Chagas en fase crónica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Adultos igual o mayores de 18 años
    •Haber sido diagnosticado de enfermedad de Chagas mediante la positividad 2 test serológicos, que utilicen diferentes antígenos
    •Consentimiento informado escrito.
    •Haber completado el protocolo de diagnóstico de los pacientes con enfermedad de Chagas del centro (Radiografía, electrocardiograma, esofagograma, enema opaco y ecocardiograma).
    •Tener una muestra de 3 con PCRrt positiva en el momento del diagnóstico.
    •Las mujeres en edad fértil deben acceder a usar método anticonceptivo adecuado o a abstenerse a mantener relaciones sexuales mientras tomen los fármacos del estudio
    •Análisis realizado en la visita de reclutamiento con parámetros de leucocitos, AST, ALT, FA, GGT, y creatinina dentro de los límites de la normalidad
    E.4Principal exclusion criteria
    •Haber recibido tratamiento previo para la infección por T. cruzi (ya sea de forma completa o incompleta)
    •Presentar enfermedades concomitantes moderadas o graves como EPOC, cáncer, valvulopatía cardiaca, cardiopatía isquémica, cardiopatía congénita, hipo o hipertiroidismo, diabetes mellitus o hipertensión arterial.
    •Presentar enfermedades que contraindiquen el tratamiento con posaconazol como la hepatopatía grave o prolongación del QT.
    •Intolerancia o alergia documentada al posaconazol
    •Recibir tratamiento con fármacos metabolizados por el CYP3A4 cómo terfenadina, astemizol, pimozida, halofantrina o quinidina y los inhibidores de la HMG-CoA reductasa (simvastatina, lovastatina y atorvastatina).
    •Pacientes en tratamiento con inhibidores de la bomba de protones o anti H2, fenitoína, efavirenz y rifabutina, o que no puedan suspenderlo durante el periodo de estudio.
    •Gestación.
    •Recibir tratamiento con diazepam
    E.5 End points
    E.5.1Primary end point(s)
    •PCR rt previo al tratamiento, a los 7, 14, 28, 45 y 60 días del inicio del tratamiento y a los 2, 4, 6 y 10 meses de acabar el tratamiento
    •Curación parasitológica a los 10 meses (si/no)
    •Densidad óptica de los ELISA para Chagas al diagnóstico, a los 6 y 10 meses de finalizar el tratamiento
    •Pendiente de curva de tendencia de las densidades ópticas de los Elisas medidos al diagnóstico, a los 6 y 10 meses de finalizar el tratamiento
    •Hemograma completo y bioquímica (AST, ALT, FA, GGT, bilirrubina total, urea y creatinina) al inicio a los 7, 14, 28 y 60 días del inicio del tratamiento.
    •Aparición de efectos adversos durante el periodo de tratamiento recogidas mediante interrogatorio y exploración física dirigida a los 7, 14, 28, 45 y 60 días del inicio del tratamiento.
    •Retirada del medicamento (si/no)
    •Buena tolerancia (si/no)
    •Medicación concomitante
    •Niveles de posaconazol en sangre periférica en le dia 14 del incio del tratamiento previa a la administración del mismo y a las 2, 3, 4, 6, 8, 10 horas de haberlo recibido
    •Clasificación de Kuschnir al incio y al final del estudio
    •Rx de tórax al incio y al final del estudio
    •Electrocardiograma al incio y al final del estudio
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    Se considerara que ha concluido el Ensayo cuando el último paciente incluido haya completado las fases de tratamiento y seguimiento.
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state78
    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 Decision2010-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
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