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    Summary
    EudraCT Number:2016-002000-31
    Sponsor's Protocol Code Number:FSJD-ISON-2016
    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:2016-08-05
    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 number2016-002000-31
    A.3Full title of the trial
    Open clinical trial phase IIa to study the isoniazid suspension absoption of 10mg/ml for the tuberculosis infection treatment in patients under the age of 6
    Ensayo clínico abierto fase IIa de estudio de la absorción de la suspensión de isoniazida a 10 mg/ml para el tratamiento de la infección tuberculosa en pacientes menores de 6 años
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open clinical trial phase IIa to study the isoniazid suspension absoption for the tuberculous infection treatment in patients under the age of 6
    Ensayo clínico abierto fase IIa de estudio de la absorción de la isoniazida para el tratamiento de la infección tuberculosa en pacientes menores de 6 años
    A.4.1Sponsor's protocol code numberFSJD-ISON-2016
    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 SponsorFUNDACIÓ SANT JOAN DE DÉU
    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
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES-CRO
    B.5.2Functional name of contact pointUnidad de Puesta en Marcha
    B.5.3 Address:
    B.5.3.1Street AddressC/ Rufino González 14 2º Dcha
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491375 69 30
    B.5.5Fax number+3491754 27 21
    B.5.6E-mailstart-up@sermescro.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 Isoniazid Syrup USP
    D.2.1.1.2Name of the Marketing Authorisation holderPharmascience INC
    D.2.1.2Country which granted the Marketing AuthorisationCanada
    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 Syrup
    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 INNISONIAZID
    D.3.9.1CAS number 54-85-3
    D.3.9.4EV Substance CodeSUB08326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    tuberculosis infection in patients under the age of 6
    Infección tuberculosa en pacientes menores de 6 años
    E.1.1.1Medical condition in easily understood language
    tuberculosis infection in patients under the age of 6
    Infección tuberculosa en pacientes menores de 6 años
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    Isoniazid maximum concentration description in serum of patients under the age of 6 in treatment with a unique oral daily dose of study drug 10mg/Kg for primary o secundary chemoprophylaxis of latent tuberculosis infection or tuberculosis disease treatment.
    Describir la concentración máxima de isoniazida en suero en una muestra de pacientes menores de 6 años tratados con el fármaco en estudio a una dosis única oral diaria de 10 mg por kg de peso para la quimioprofilaxis primaria o secundaria de la infección tuberculosa latente o el tratamiento de la enfermedad tuberculosa.
    E.2.2Secondary objectives of the trial
    - Describe other pharmacokinetic parameters (are under the curve, time to the maximum concentration), after the isoniazid administration in a unique oral daily dose of 10mg/kg in the study population and the equivalence between the two groups of patients: baby from 1 month to 2 years; and preschoolers, from 2 to 6 years of life.
    - Study the influence of other factors in the pharmacokinetics parameters studied: gender, nutritional state, treatment indication (primary or secundary chemoprophylaxis of the latent tuberculosis infection or tuberculosis disease treatment), acetylator NAT2 genotype and coadministration of other tuberculostatic drugs.
    - Treatment security.
    - Describir otros parámetros farmacocinéticos (área bajo la curva, tiempo a la concentración máxima), tras la administración de isoniazida en una dosis única oral diaria de 10 mg por kg de peso en la población en estudio, y su equivalencia entre los dos grupos de pacientes: lactantes, de 1 mes a 2 años de vida; y prescolares, de 2 a 6 años de vida.
    - Estudiar la influencia de otros factores en los parámetros farmacocinéticos estudiados: género, estado nutricional, indicación de tratamiento (quimioprofilaxis primaria o secundaria de la infección tuberculosa latente o tratamiento de la enfermedad tuberculosa), genotipo acetilador NAT2 y co-administración de otros fármacos tuberculostáticos.
    - Seguridad del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients between > or = 29 days and < or = 6 years old.
    - Patients who require primary or secundary chemoprophylaxis, or treatment for the tuberculosis infection with isoniazid in monotherapy or together other anti-tuberculosis drugs.
    - Informed consent signed by parents and tutors.
    - Pacientes entre > o = 29 días y < o = 6 años de vida.
    - Pacientes que precisen quimioprofilaxis primaria o secundaria, o tratamiento para la infección tuberculosa con isoniazida, en monoterapia o junto a otros fármacos anti-tuberculosos.
    - Formulario de consentimiento informado firmado por los padres o tutores.
    E.4Principal exclusion criteria
    - Any infection disease, hepatic or renal of base susceptible to alter the isoniazid metabolism (i.e. VIH infection or hepatotropos virus).
    - Treatment necesity with other drugs liable to modify the isoniazid metabolism (i.e. antiepileptic, antiretroviral, etc.).
    - Study basal hepatic function alteration, defined with a elevation in the alanine aminotransferases levels two or three times the normality higher level, it is 40 UI/L per 2: values > or 80UI/L.
    - Cualquier enfermedad infecciosa, hepática o renal de base susceptible de alterar el metabolismo de la isoniazida (ej. infección por VIH o virus hepatotropos).
    - Necesidad de tratamiento con otros fármacos susceptibles de alterar el metabolismo de la isoniazida (ej. antiepilépticos, antirretrovirales, etc.).
    - Alteración de la función hepática en el estudio basal, definida por una elevación de los niveles de alanino aminotransferasa (ALT) dos o más veces el valor superior de la normalidad, o sea, 40 UI/L por 2: valores > o = 80 UI/L.
    E.5 End points
    E.5.1Primary end point(s)
    Maximum concentration (Cmax) in serum of isoniazid (quantitative variable, in mg/L)
    Concentración máxima (Cmax) en suero de isoniazida (variable cuantitativa, en mg/L).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients in monoterapy:1 or 2 hours post-dosis, 3 or 4 hours post-dose, 6 or 8 hours post-dosis.
    In combined treatment with other drugs anti-tuberculose : Pre-dose, 1 or 2 hours post-dose, 3 or 4 hours post-dose, 6 or 8 hours post-dose and 10 or 12 hours post-dose
    Pacientes en monoterapia: 1 o 2 horas post-dosis, 3 o 4 horas post-dosis, 6 o 8 horas post-dosis.
    En tratamiento combinado con otros fármacos anti-tuberculosos: Pre-dosis, 1 o 2 horas post-dosis, 3 o 4 horas post-dosis, 6 o 8 horas post-dosis y 10 o 12 horas post-dosis.
    E.5.2Secondary end point(s)
    - Time to the maximum concentration in serum of isoniazid (quantitative variable, in hours).
    - Minimum concentration in serum of isoniazid (quantitative variable, in mg/L).
    - Area under the curve of isoniazid concentration in serum (quantitative variable, in mg h/L). From time 0 to 6h (AUC6) and time from 0 to 24h (AUC24) in a posological interval.
    - Plasmatic clearance of isoniazid (quantitative variable, in L/h)
    - Apparent distribution volume of isoniazid ( quantitative variable, in liters).
    - Acetylator genotype (qualitative variable): quick homozygote acetylator, slow homozygote acetylator, or intermediate acetylator.
    - In patients with tuberculosis disease: disease type (intrathoracic or extratoracic; dichotomic variable) and concomitant treatments with other tuberculostatic drugs (yes/no; dichotomic variable).
    - Malnutrition (yes/no, dichotomic variable). Defined with weight and/or body mass index lower than -2DS according to the Spanish standar.
    - Gender, gestational state and weight in the moment of birth, indication about the treatment with isoniazid (primary or secondary chemoprophylaxis of ITL, or tuberculosis disease treatment); age, weight and total daily dose of isoniazid and basal levels of alanine aminotransferase (ALT-UI/mL) to the initial treatment indication with isoniazid; adherence and adverse events to the treatment with isoniazid.
    - Tiempo a la concentración máxima (tmax) en suero de isoniazida (variable cuantitativa, en horas).
    - Concentración mínima (Cmin) en suero de isoniazida (variable cuantitativa, en mg/L).
    - Área bajo la curva (AUC) de concentración de la isoniazida en suero (variable cuantitativa, en mg h/L). De tiempo 0 a 6h (AUC6) y de tiempo 0 a 24h (AUC24) en un intervalo posológico.
    - Aclaramiento plasmático (CL) de isoniazida (variable cuantitativa, en L/h).
    - Volumen aparente de distribución (Vd) de isoniazida (variable cuantitativa, en litros).
    - Genotipo acetilador (variable cualitativa): acetilador rápido homozígoto (RR), acetilador lento homozígoto (LL), o acetilador intermedio (RL).
    - En los pacientes con enfermedad tuberculosa: tipo de enfermedad (intratorácica o extratorácica; variable dicotómica) y tratamiento concomitante con otros fármacos tuberculostáticos (sí/no; variable dicotómica).
    - Desnutrición (sí/no, variable dicotómica). Definida por un peso y/o índice de masa corporal inferior a -2 DS de acuerdo a los estándares españoles.
    - Género, estado gestacional y peso al nacimiento, indicación de tratamiento con isoniazida (quimioprofilaxis primaria o secundaria de la ITL, o tratamiento de la enfermedad tuberculosa); edad, peso y dosis total diaria de isoniazida, y niveles basales de alanina aminotransferasa (ALT - UI/mL) a la indicación inicial del tratamiento con isoniazida; adherencia y efectos adversos al tratamiento con isoniazida.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients in monotherapy: 1 or 2 hours post-dose, 3 or 4 hours post-dose, 6 or 8 hours post-dose.
    In combinate treatment with other drugs anti-TB: Pre-dose, 1 or 2 hours post-dose,3 or 4 hours post-dose, 6 or 8 hours post-dose and 10 or 12 hours post-dose.
    Pacientes en monoterapia: 1 o 2 horas post-dosis, 3 o 4 horas post-dosis, 6 o 8 horas post-dosis.
    En tratamiento combinado con otros fármacos anti-TB: Pre-dosis, 1 o 2 horas post-dosis, 3 o 4 horas post-dosis, 6 o 8 horas post-dosis y 10 o 12 horas post-dosis.
    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 No
    E.6.4Safety Yes
    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) 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.8.3 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
    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
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 44
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 22
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 22
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Under 18 years old.
    Menores de edad.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    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)
    No aplicable
    No aplica
    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 Decision2016-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-20
    P. End of Trial
    P.End of Trial StatusOngoing
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