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    Summary
    EudraCT Number:2011-002900-34
    Sponsor's Protocol Code Number:CINE-BENZ
    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:2011-12-21
    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 number2011-002900-34
    A.3Full title of the trial
    Population Pharmacokinetics in Benznidazol-treated adults with Chronic Chagas Disease. Benznidazol Pharmacokinetics and adverse reactions relationship.
    Estudio de Farmacocinética Poblacional de Benznidazol en pacientes adultos con Enfermedad de Chagas. Relación entre la farmacocinética de Benznidazol y la aparición de efectos adversos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the variabiliy in dose-concentration correlation of Benznidazol in adult patients with Chronic Chagas Disease and the relationship between drug pharmacokinetics and adverse reactions.
    A.3.2Name or abbreviated title of the trial where available
    Population Pharmacokinetics in Benznidazol-treated adults with Chronic Chagas Disease
    A.4.1Sponsor's protocol code numberCINE-BENZ
    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- International Research Center in Health of Barcelona
    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 supportMundo Sano
    B.4.2CountryArgentina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRESIB-International Research Center in Health of Barcelona
    B.5.2Functional name of contact pointCRESIB
    B.5.3 Address:
    B.5.3.1Street AddressRoselló street 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 50 patients with Chronic Chagas Disease.
    En el estudio participarán 50 pacientes diagnosticados de Enfermedad de Chagas crónica.
    E.1.1.1Medical condition in easily understood language
    The study will be held in patients with a chronic disease caused by a parasite called Tripanosoma cruzi.
    El estudio se realizará en pacientes con enfermedad crónica causada por un parásito llamado Tripanosoma cruzi.
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008384
    E.1.2Term Chagas' disease
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study population pharmacokinetics in Benznidazol-treated adult patients with Chronic Chagas Disease to get information to optimaze drug doses.
    Confirmar en una serie de pacientes adultos con Enfermedad de Chagas el comportamiento farmacocinético de Benznidazol con el objetivo de establecer posteriores régimenes de dosificación que permitan optimizar su terapéutica.
    E.2.2Secondary objectives of the trial
    1. To find relationship between Benznidazol pharmacokinetics and other different factors as demographic factors (age, weight, gender), biochemical factors (renal function, hepatic function) or physiopatological factors (adverse reactions), to try to understand drug's interindividual variability.
    2. To find if there is any relationship between drug's serum concentration and adverse reactions.
    1. Cuantificar el efecto que ejercen distintos factores como los demográficos (edad, peso, sexo), bioquímicos (función renal y hepática) o fisiopatológicos (aparición de efectos adversos), en el comportamiento farmacocinético de Benznidazol con el fin de explicar su variabilidad interindividual.
    2. Establecer una posible relación entre la concentración del fármaco y la aparición de efectos adversos debidos al fármaco.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests.
    - Patients with Chronic Chagas Disease who are going to start treatment with Benznidazol.
    - Any gender.
    - All the participants must agree to participate in the study and must sign the informed consent.
    - Pacientes adultos diagnosticados de Enfermedad de Chagas crónica con 2 serología diferentes positivas.
    - Pacientes con Enfermedad de Chagas crónica que empezarán tratamiento con Benznidazol.
    - Cualquier género.
    - Todos los pacientes deben estar de acuerdo en participar en el estudio y firmar el documento de consentimiento informado.
    E.4Principal exclusion criteria
    - Patients yonger than 18.
    - Patients with previous hipersensitivity to Benznidazol.
    - Inmunocompromised patients as AIDS, cancer, chemoterapy, long-term corticoids need, primary inmunodeficiency, or any other.
    - Hepatic dysfunction
    - Renal dysfunction: serum creatinin higher than 3 mg/dl.
    - Pregnancy or lactation.
    - Low adhesion to treatment or check-up.
    - Imposibility of follow-up.
    - Severe adverse reaction to Benznidazol.
    - Any other situation that could be risky for the patient.
    - Pacientes menores de 18 años.
    - Pacientes con Hipersensibilidad previa al Benznidazol.
    - Pacientes con enfermedades inmunosupresoras como SIDA, cancer, quimioterapia, tratamientos corticoideos de larga duración, immunodeficiencias primarias o cualquier otra situación que pueda compremeter el sistema immune.
    - Insuficiencia hepática.
    - Insuficiencia renal: creatinina sérica de mayor de 3mg/dl.
    - Embarazo o lactancia.
    - Baja adherencia al tratamiento o a los controles.
    - Reacciones graves al Benznidazol.
    - Cualquier otra situación que se considere de riesgo para el paciente.
    E.5 End points
    E.5.1Primary end point(s)
    There is no study held before this one where Benznidazol's population pharmacokinetics have being analyzed, so this will be a pioneering
    study. Because of that all the results will be collected.
    No existen estudios previos donde se analice la farmacocinética poblacional del Benznidazol, por lo que este estudio será pionero. Por lo tanto, se intentará extraer toda la información en relación a la farmacocinética poblacional.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Asuming the recruitment and treatment periods, about 18 month will be needed.
    Se estima que se necesitarán unos 18 meses contando con el reclutamiento y tratamiento de los pacientes.
    E.5.2Secondary end point(s)
    To analyze if there is a relationship between Banznidazol's plasma concentration and the seriousness o frecuency of adverse reactions.
    Analizar la posible relación entre la concentración plasmática de Benznidazol y la frecuencia y gravedad de la aparición de efectos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Asuming the recruitment and treatment periods, about 18 month will be needed.
    Se estima que se necesitarán unos 18 meses, incluyendo el tiempo de reclutamiento y tratamiento de los pacientes.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 50
    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 No
    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 state50
    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 subjets have ended the participation in the trial 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 trial participation than regular patients.
    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 Decision2012-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
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