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    Summary
    EudraCT Number:2018-000564-28
    Sponsor's Protocol Code Number:IIBSP-QTL-2017-96
    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:2018-03-13
    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 number2018-000564-28
    A.3Full title of the trial
    Genetic characterization of drug-induced Long QT Syndrome
    Caracterización Genética del Síndrome del QT Largo Asociado a Fármacos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Genetic characteristics of the Long QT Syndrome that appears with certain pharmacological treatments
    Características Genéticas del Síndrome del QT Largo que aparece con tratamientos farmacológicos
    A.4.1Sponsor's protocol code numberIIBSP-QTL-2017-96
    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 SponsorInstitut de Recerca H. de la Santa Creu i Sant Pau - IIB Sant Pau
    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 supportCarlos III Health Institute
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca H. de la Santa Creu i Sant Pau - IIB Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935537636
    B.5.5Fax number+34935537812
    B.5.6E-mailepenag@santpau.cat
    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 Adrenalina B. Braun
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Medical, SA
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEPINEPHRINE HYDROCHLORIDE
    D.3.9.1CAS number 55-31-2
    D.3.9.3Other descriptive nameEPINEPHRINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01912MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number42
    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
    Drug-induced Long QT Syndrome
    Síndrome QT-Largo farmacológico
    E.1.1.1Medical condition in easily understood language
    Long QT Syndrome that appears with certain pharmacological treatments
    Síndrome QT-Largo que aparece con medicamentos
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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
    -Identify the genetic alterations associated with drug-induced long QT syndrome in our environment.
    -To evaluate, in patients with drug-induced long QT syndrome, the response to the adrenaline test and its relationship with the genetic study
    -Identificar las alteraciones genéticas asociadas al SQTL farmacológico en nuestro entorno.
    -Evaluar, en pacientes con QT largo farmacológico, el tipo de respuesta al test de adrenalina y su relación con el estudio genético
    E.2.2Secondary objectives of the trial
    -Compare the genetic alterations associated with drug-induced long QT syndrome in our environment with those documented in other populations.
    -To estimate the prevalence of drug-induced long QT syndrome in our environment.
    -Identify the drugs most commonly associated with drug-induced long QT syndrome in our environment.
    -Comparar las alteraciones genéticas asociadas al SQTL farmacológico en nuestro entorno con las documentadas en otras poblaciones.
    -Estimar la prevalencia del SQTL farmacológico en nuestro entorno.
    -Identificar los fármacos más comúnmente asociados a SQTL farmacológico en nuestro entorno.
    -Evaluar, en pacientes con QT largo farmacológico, el tipo de respuesta al test de adrenalina y su relación con el estudio genético
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients older than 18 years with a confirmed diagnosis of drug-induceded long QT syndrome who want to participate in the study and sign the informed consent.
    Pacientes mayores de 18 años con diagnóstico confirmado de SQTL farmacológico, que quieran participar en el estudio y firmen el consentimiento informado.
    E.4Principal exclusion criteria
    -Patients under 18 years old
    -Patients of non-Caucasian ethnicity
    -Patients with a family history of congenital long QT syndrome
    -Patients with complete left bundle branch block, stimulated rhythms or non-sinus rhythms not related to SQTL
    -Patients with electrolyte abnormalities
    -Patients who do not sign informed consent
    -Menores de 18 años
    -Pacientes de etnia no caucásica
    -Pacientes con antecedentes familiares de QT largo congénito
    -Pacientes con bloqueo completo de rama izquierda, ritmos estimulados o ritmos no sinusales no relacionados con SQTL
    -Pacientes con alteraciones electrolíticas
    -Pacientes que no firmen el consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    Regarding the adrenaline test, the main endpoint will be the appearance of a paradoxical response of the QT interval in the electrocardiogram, defined as an extension of this interval> 30 ms with the adrenaline administration.
    En cuanto a la prueba de adrenalina, la variable principal de respuesta será la aparición de una respuesta paradójica del intervalo QT en el electrocardiograma, definida como una extensión de este intervalo> 30 ms con la administración de adrenalina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint of this endopoint will be evaluated at the time of the adrenaline test, which will perfomed early after inclusion of the patient in the study.
    Se evaluará en el momento de la prueba de adrenalina, que se realizará después de la inclusión del paciente en el estudio.
    E.5.2Secondary end point(s)
    NA
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial120
    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
    Última visita del último sujeto
    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 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: 120
    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 state120
    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)
    Expected normal treatment of the condition
    Tratamiento 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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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