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    Summary
    EudraCT Number:2011-002022-41
    Sponsor's Protocol Code Number:CHAGAS-EVOL I
    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:2011-07-12
    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 number2011-002022-41
    A.3Full title of the trial
    Assessment of Therapeutic Response to Benznidazole in patients with Chronic Chagas Disease by Measuring Plasma Parasite Load and the Specific Immune Response against Trypanosoma cruzi. A Randomized, open label, Pilot Clinical Trial
    Evaluación de la respuesta terapéutica con benznidazol en sujetos con enfermedad de Chagas crónica, mediante la medición de la carga parasitaria plasmática por PCR cuantitativa y la respuesta inmune específica frente a Tripanosoma cruzi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of Therapeutic Response to Benznidazole in patients with Chronic Chagas Disease.
    Evaluación de la respuesta terapéutica a benznidazol en pacientes con enfermedad de Chagas crónica.
    A.4.1Sponsor's protocol code numberCHAGAS-EVOL I
    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 para la Investigación Biomédica del 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 supportMinisterio de Sanidad y Política Social e Igualdad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica del Hospital Ramón y Cajal
    B.5.2Functional name of contact pointJosé A. Pérez Molina
    B.5.3 Address:
    B.5.3.1Street AddressCtra. Colmenar Viejo km 9.100
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number00340913368100
    B.5.5Fax number00340913368825
    B.5.6E-mailjose.perezmolina@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 Radanil
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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.3.1Product 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 INNBENZNIDAZOLE
    D.3.9.1CAS number 22994-85-0
    D.3.9.2Current sponsor codeBenznidazole
    D.3.9.4EV Substance CodeSUB05753MIG
    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
    Chagas disease
    Enfermedad de Chagas
    E.1.1.1Medical condition in easily understood language
    Asymptomatic chronic Chagas disease
    Enfermedad de Chagas crónica asintomática
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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 compare the evolution of the parasite load at baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients.
    ? To compare the evolution of the specific immune response against T. cruzi at
    baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients.
    - Comparar la carga parasitaria basal y su evolución durante el tratamiento y en los 16 meses post-tratamiento con benznidazol en los pacientes tratados y no tratados.
    - Comparar las respuests inmunes específicas frente a T. Cruzi basales y su evolución durante el tratamiento y en los 16 meses post-tratamiento con benznidazol, en los pacientes tratados y no tratados.
    E.2.2Secondary objectives of the trial
    ? To evaluate and standardized molecular and immunological techniques for use
    in clinical practice.
    ? To describe the safety profile of treatment with benznidazole.
    ? To evaluate quantitative PCR and the specific immune response against T. cruzi as long term response surrogate markers.
    - Evaluar y poner a punto técnicas moleculares e inmunológicas que pueden ser de utilidad en la práctica clínica diaria.
    - Describir el perfil de seguridad del tratamiento con benznidazol.
    - Evaluar la PCR cuantitativa y la respuesta inmune específica frente a T. cruzi como marcadores de respuesta a largo plazo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Participant willing and able to give informed consent for participation in the study
    ?Ability to understand study procedures and to comply with them for the entire length of the study
    ?Men and women, more than 20 and less than 50 years old with asymptomatic chronic Chagas disease
    ?No urgent need for benznidazole therapy
    ?Detectable T. cruzi in blood (positive qualitative PCR)
    ?For women of childbearing age an effective contraceptive method must be used during the treatment period and in the month following treatment
    - Pacientes que tras haber recibido información sobre el diseño, los fines del estudio, los posibles riesgos que de él puedan derivarse y de que en cualquier momento puedan denegar su colaboración, otorguen por escrito su consentimiento para participar.
    - Hombres y mujeres mayores de 20 años y menores de 50 años con enfermedad de Chagas crónica asintomática.
    - Sin necesidad urgente de tratamiento con benznidazol.
    - T. cruzi detectable en sangre (positivo PCR cualitativa).
    - Las mujeres en edad fértil deberán utilizar un método anticonceptivo efectivo durante el período de tratamiento y en el mes posterior al tratamiento.
    E.4Principal exclusion criteria
    ?Symptomatic acute or chronic Chagas disease
    ?Current pregnancy
    ?Previous therapy with benznidazole, nifurtimox or any other tripanocidal drug
    ?Severe hepatic or renal impairment
    ?Inability to give written informed consent
    - Enfermedad de Chagas aguda o crónica sintomática.
    - Tratamiento previo con benznidazol, nifurtimox o cualquier otro fármaco tripanocida.
    - Insuficiencia hepática o renal severa.
    - Imposibilidad de dar el consentimiento informado por escrito.
    E.5 End points
    E.5.1Primary end point(s)
    The change in parasite load from baseline by quantitative PCR and the development of a specific immune response against T. cruzi analising of the frequency of T. cruzi specific T-cells secreting ?-IFN and IL-2, as well as measurements of the degree of activation of CD4 and CD8 T lymphocytes and B lymphocytes.
    Cambio de la carga parasitaria respecto de la basal medida por PCR cuantitativa y desarrollo de una respuesta inmune específica frente a T. cruzi analizando la frecuencia de linfocitos T específicos para T. cruzi productores de interferón gamma y de interleucina-2 asi como el grado de acrtivación de linfocitos T CD4, T CD8 y B.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, day +15, day +60, month +5, month +11 and month +18.
    Basal, día +15, día +60, mes +5, mes +11 y mes +18.
    E.5.2Secondary end point(s)
    Adverse events reported
    Acontecimientos adversos notificados
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day +15 and day +60.
    Día +15 y día +60.
    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 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) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Delayed intervention group
    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.8.4.1Number 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
    The end of trial is the date of the last visit: M18 for those patients randomized to immediate intervention group (IIG) and M36 for those randomized to delayed intervention group (DIG).
    Final del ensayo viene definido por la fecha de la última visita: mes +18 para los pacientes aleatorizados en el grupo de intervención inmediata (IIG) y mes +36 para aquellos asignados al grupo de intervención tardía (DIG).
    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 months5
    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 months5
    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: 40
    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 state40
    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)
    All patients will be followed-up long-term at our Unit after study termination as per routine clinical practice.
    Se realizará un seguimiento a largo plazo en la Unidad después de la terminación del estudio a todos los pacientes siguiendo la práctica clínica habitual.
    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 Decision2011-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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