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    Summary
    EudraCT Number:2012-002645-38
    Sponsor's Protocol Code Number:BIOMARCHA
    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:2012-08-07
    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 number2012-002645-38
    A.3Full title of the trial
    Evolution of serologic biomarkers and diastolic function and segmentary contractility determined by echocardiography after treatment in Chagas diseases
    Evolución de los marcadores serológicos y de la función diastólica y contractilidad segmenteria determinada por ecocardiografía en la Enfermedad de Chagas tras el tratamiento antiparasitario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chagas disease is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.
    La enfermedad de Chagas es endémica en Latinoamérica y en importante emergencia en países no endémicos debido a la migración de individuos infectados con T. cruzi. Los actuales métodos diagnósticos de la infección no son los ideales. Los tratamientos existentes son limitados, producen severos efectos secundarios y su eficacia no puede ser correctamente evaluada. En este estudio se investigarán biomarcadores de pronóstico, diagnóstico temprano y eficacia del tratamiento.
    A.3.2Name or abbreviated title of the trial where available
    New tools for the diagnosis, prognosis & treatment follow-up in Chagas disease
    Nuevas herramientas de diagnóstico, pronóstico y tratamiento en la Enfermedad de Chagas
    A.4.1Sponsor's protocol code numberBIOMARCHA
    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 SponsorCRESIB-Barcelona Centre for International Health Research
    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 supportFondo de Investigación Sanitaria (FIS, Spanish Government)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRESIB-Barcelona Centre for International ealth Research
    B.5.2Functional name of contact pointCRESIB
    B.5.3 Address:
    B.5.3.1Street AddressRoselló 132, 4th 2nd
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number00349322754003288
    B.5.5Fax number0034932279853
    B.5.6E-mailjgascon@clinic.ub.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 No
    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.3.1Product nameBenznidazol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 0022994-85-0
    D.3.9.3Other descriptive nameBenznidazol
    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) 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
    The study will be held in 63 patients with chronic Chagas Disease and 63 healthy people
    En el estudio participarán 63 pacientes con Enfermedad de Chagas y 63 personas sanas
    E.1.1.1Medical condition in easily understood language
    The study will be held in 63 patients with chronic Chagas Disease and 63 healthy people
    En el estudio participarán 63 pacientes con Enfermedad de Chagas y 63 personas sanas
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    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
    Chagas disease (CD), caused by Trypanosoma cruzi, is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.
    La enfermedad de Chagas (EC), causada por Trypanosoma cruzi, es endémica en Latinoamérica y en importante emergencia en países no endémicos debido a la migración de individuos infectados con T. cruzi. Los actuales métodos diagnósticos de la infección no son los ideales. Los tratamientos existentes son limitados, producen severos efectos secundarios y su eficacia no puede ser correctamente evaluada. En este estudio se investigarán biomarcadores de pronóstico, diagnóstico temprano y eficacia del tratamiento.
    E.2.2Secondary objectives of the trial
    1. To analize the evolution patterns of molecular diagnostic techniques (conventional PCR and quantitative real-time PCR) of T. cruzi in blood, brain natriuretic factor, prothrombotic factors (prothrombotin fragment and endogenous thrombin potential), antibodies against specific proteins of the trypomastigote of T. cruzi (KMP11, HSP70, PFR2 and peptid 3973), and their correlation with alterations of the left ventricle diastolic function and segmentary contractility after antiparasitis treatment.
    2.To investigate the phylogenetics of the parasite and the role of the lineages of T.cruzi in the clinical presentation and disease's progression (tissue /organ tropism may be lineage-dependant).
    3. To validate the specific seric proteins as biomarkers by a Surface Enhanced Laser Desorption Ionization Time Of Flight Mass Spectrometry (SELDIToF) in a substudy.
    1. Analizar el patrón de evolución en el tiempo de la PCRus, BNP, marcadores de hipercoagulabilidad (F1+2; ETP) y anticuerpos anti-proteinas de T. cruzi (KMP11, HSP70, PFR2 y péptido 3973) y su correlación con los cambios en la función diastólica y contractilidad segmentaria del ventrículo izquierdo tras el inicio del tratamiento antiparasitario.
    2. Investigar la filogenética del parásito y los linajes de T. cruzi y correlacionarlo con la afectación cardíaca en la Enfermedad de Chagas.
    3. Hacer un subestudio piloto para identificar proteínas séricas específicas en los pacientes infectados como posibles biomarcadores asociados a la EC, mediante la espectrofotometría de masas SELDIToF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients from Chagas Disease endemic areas.
    -Older than 18 years old and younger than 50.
    -With serological confirmation of the infection with two different techniques.
    -Indeterminate or initial cardiac form
    -No previously treated
    -Pacientes procedentes de zona endémica de Enfermedad de Chagas
    -Rango de edad entre 18-50 años
    -Con confirmación serológica de la enfermedad por dos técnicas
    -En fase indeterminada o cardíaca inicial de la enfermedad
    -Que no hayan recibido tratamiento previo
    E.4Principal exclusion criteria
    Co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent (HBV, HCV, HIV). Hepatic disfunction (elevation of ALT, AST, GGT or bilirrubine), pregnancy or lactation
    Co-morbilidad: enfermedad cardiaca previa de otra etiología (isquémica, alcohólica o hipertensiva), enfermedad inflamatoria activa o inmunológica por otras causas (VHB; VHC; VIH). Disfunción hepática (elevación GOT, GPT, GGT o bilirrubina), embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    -Statistically significant correlation among the evolution of different molecular factors and echocardiography after antiparasitic treatment
    -Statistically significant correlation between phylogenetics of the parasite and clinical presentation of the disease
    -Validation as biomarkers of specific seric proteins comparing previous studies
    -Correlación estadísticamente significante entre la evolución de los diferentes factores molculares y el ecocardiograma tras el tratamiento antiparasitario
    -Correlación estadísticamente significante entre la filogenética del parásito y la presentación clínica de la enfermedad
    -Validación de las proteinas séricas específicas como biomarcadores en la Enfermedad de Chagas
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study will take about 36 months
    La duración estimada del estudio es de 36 meses
    E.5.2Secondary end point(s)
    -Statistically significant correlation among the evolution of different molecular factors and echocardiography after antiparasitic treatment
    -Statistically significant correlation between phylogenetics of the parasite and clinical presentation of the disease
    -Validation as biomarkers of specific seric proteins comparing previous studies
    -Correlación estadísticamente significante entre la filogenética del parásito y la presentación clínica de la enfermedad
    -Validación de las proteinas séricas específicas como biomarcadores en la Enfermedad de Chagas
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months
    36 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 126
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state126
    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)
    When the subjects have ended the participation in the study they are going to be monitorized as regular patients due to the fact that they are not assuming or doing any different treatment during the study than regular patients. Healthy volunteers are not receiveng any treatment and when the study is finished they will be discharged.
    Cuando los participantes en el estudio finalicen su participación seguirán los controles habituales en la consulta. El tratamiento farmacológico que recibirán durante el estudio es el mismo que recibirían si no participaran en él, y después de su participación seguiran con los controles habituales. Los pacientes sanos serán dados de alta al finalizar el estudio si no requieren ninguna asistencia médica.
    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 Decision2012-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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