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    Summary
    EudraCT Number:2012-002094-58
    Sponsor's Protocol Code Number:UITB-TBTC-Estudio33
    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:2012-06-12
    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 number2012-002094-58
    A.3Full title of the trial
    An evaluation of adherence to LTBI treatment with 12 doses of once weekly rifapentine and isoniazid given as self-administered versus directly-observed therapy: iAdhere
    Evaluación de la adherencia a un tratamiento para la Infección Tuberculosa Latente con 12 dosis, una vez a la semana, de rifapentina e isoniacida en pauta auto-administrada versus tratamiento directamente observado: iAdhere
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An evaluation of adherence to latent tuberculosis infection treatment with 12 doses given as self-administered versus directly-observed therapy
    Evaluación de la adherencia a un tratamiento de la Infección Tuberculosa Latente de 12 dosis en pauta auto-administrada versus tratamiento directamente observado
    A.3.2Name or abbreviated title of the trial where available
    iAdhere
    iAdhere
    A.4.1Sponsor's protocol code numberUITB-TBTC-Estudio33
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01582711
    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 SponsorUnidad de Investigación en Tuberculosis de Barcelona (UITB)
    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 supportCenters for Disease Control and Prevention (CDC)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación en Tuberculosis de Barcelona (UITB)
    B.5.2Functional name of contact pointJoan Caylà
    B.5.3 Address:
    B.5.3.1Street AddressPlaza Lesseps 1
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08023
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932384545353
    B.5.6E-mailjcayla@aspb.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 PRIFTIN
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameRifapentine
    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 INNRIFAPENTINE
    D.3.9.1CAS number 61379-65-5
    D.3.9.4EV Substance CodeSUB10311MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.IMP: 2
    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 Tablets, USP
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMACEUTICALS USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameISONIAZID
    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 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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Adherence study in subjects with Latent Tuberculosis Infection
    Estudio de adherencia en sujetos con Infeción Tuberculosa Latente
    E.1.1.1Medical condition in easily understood language
    Adherence study in subjects with Latent Tuberculosis Infection
    Estudio de adherencia en sujetos con Infeción Tuberculosa Latente
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation.
    Comparar las tasas de tratamientos completados entre los participantes aleatorizados al grupo de TDO versus AA sin recordatorio, y TDO vs AA con recordatorio SMS semanal. Tratamiento completado se define como tomar al menos el 90% de las dosis (11 de 12 dosis de cada fármaco) en el plazo de 16 semanas desde el inicio del tratamiento.
    E.2.2Secondary objectives of the trial
    A.To compare the treatment completion rates between SAT without reminders vs SAT with reminders
    B.To evaluate the timing of doses and patterns of adherence among participants who complete treatment and those who discontinue therapy prior to completion. Participants may fail to complete treatment due to an AE despite having excellent adherence.
    C.To determine the availability and acceptability of SMS reminders
    D.To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 AE or death between the DOT arm and the SAT arms (both combined and individually)
    E.To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms (combined and individually) including discontinuation due to: non-adherence/ any AE/ a diagnosis of active TB/ other reasons
    F.To collect patient-specific cost data
    G.To describe the pattern resistances among MTB strains from participants who develop active TB.
    A.Comparar las tasas de tratamientos completados entre el grupo AA sin recordatorios vs AA con recordatorio SMS
    B.Evaluar el calendario de tomas de las dosis y patrones de adherencia entre participantes que completen el tratamiento y aquellos no. Puede que los participantes no completen el tratamiento debido a un EA aun mostrando una adherencia excelente.
    C.Disponibilidad y la aceptación del recordatorio por SMS
    D.Determinar la toxicidad y la tolerabilidad comparando las tasas de EAs grado 3 o 4 o mortalidad relacionados con la medicación entre la rama TDO y las ramas AA (combinadas y por separado)
    E.Comparar la frecuencia, temporalidad, y causas de no completar el tratamiento entre la rama TDO y las AA (combinadas y por separado) incluyendo la interrupción por: falta de adherencia/cualquier EA/diagnóstico de TB/otras razones
    F.Recoger datos en relación al coste específico por paciente
    G.Describir el patrón de la resistencia de cepas de MTB de pacientes que desarrollen TB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and non-pregnant, non-nursing females
    Age >= 18 years Edad >= 18
    Weight >= 45kg and considered appropriate to receive 900mg of RPT and 900mg of INH once weekly by the local site investigator
    Willingness to provide signed informed consent
    Any clinical indication for LTBI treatment as locally defined
    Hombres y mujeres (no embarazadas no lactantes)
    Edad > 18
    Peso > 45kg y en que considere el Investigador del Centro apropiado dar 900mg de RPT y 900mg de INH semanal.
    Voluntad del paciente de firmar el consentimiento informado.
    Cualquier indicación considerada localmente para tratamiento de la infección tuberculosa latente
    E.4Principal exclusion criteria
    - Confirmed or suspected active TB
    - Contacts to a source case with known resistance to isoniazid or rifampin.
    - Women who are pregnant, breastfeeding, or planning to get pregnant within 120 days of study start
    - Persons with a history (by written documentation or self-report) of ever receiving > 1 week of treatment for active or latent TB, regardless of whether the course was completed, because adherence may be different in people who previously took any TB treatment
    - Persons who are not considered candidates for SAT by the local investigator
    - History of sensitivity or intolerance to isoniazid or rifamycins
    - Serum alanine aminotransferase (ALT, SGPT) > 5x upper limit of normal among persons in whom an ALT is determined
    - Persons with HIV-infection who
    1. have a CD4 < 350 or
    2. are currently receiving or planning to receive antiretroviral therapy in the first 120 days after study initiation (e.g., HIV-1 protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, CCR5 inhibitors or integrase inhibitors)

    Prisoners will not be eligible for study enrollment. Any participant who gets incarcerated during the treatment phase of the study will be removed from the study and referred for continued care and LTBI treatment per the local standard practices.
    - Sospecha o confirmación de TB activa.
    - Ser contacto de un caso índice con resistencia conocida a la isoniacida o rifampicina.
    - Mujeres embarazadas, en período de lactancia, o que planeen quedar embarazadas en un plazo de 120 días después del inicio del estudio.
    - Personas con historia (documentada o reportada por el propio paciente) de haber recibido > 1 semana de tratamiento de TB activa o latente, sin tener en cuenta si se completó el tratamiento, ya que la adherencia puede diferir en personas que hayan tomado previamente tratamiento para la TB.
    - Personas que no sean consideradas candidatas para tratamiento AA por el Investigador local.
    - Historia de sensibilidad o intoleracia a isoniacida o rifamicinas.
    - Alanina aminotransferasa sérica (ALT, SGPT) mayor a 5 veces el nivel del límite superior normal, en personas en las que la ALT haya sido determinada.
    - Personas con infección por VIH que:
    1. tengan CD4 < 350 ó
    2. estén actualmente recibiendo o vayan a recibir terapia antiretroviral en el plazo de los 120 días tras el inicio del estudio (por ejemplo: inhibidores de la proteasa HIV-1, inhibidores nucleósidos o no-nucleósidos de la transcriptasa inversa, inhibidores CCR5 o inhibidores de la integrasa)

    Los presos no serán aptos para la inclusión. Cualquier participante que ingrese en prisión durante el la fase de tratamiento del estudio será retirado del estudio y derivado para continuar el tratamiento de la infección latente de acuerdo con las practicas estándar locales.
    E.5 End points
    E.5.1Primary end point(s)
    1. Completion of therapy defined as taking at least 11 of 12 once weekly doses of RPT/INH within 16 weeks after the first study dose
    2. Failure to complete therapy for any reason including:
    a. The development of culture-confirmed or clinically diagnosed TB during treatment
    b. Confirmation of INH or rifampin resistance in a source case for participants enrolled as contacts prior to susceptibility results
    c. Discontinuation due to an adverse study-drug reaction, including any grade 3 or higher toxicity
    d. Death due to any cause
    e. Loss to follow-up
    1. Tratamiento completado definido como tomar como mínimo 11 de las 12 dosis semanales de RPT/INH en 16 semanas desde la toma de la primera dosis.
    2. Tratamiento no completado por cualquier razón incluyendo:
    a. Desarrollo de TB durante el tratamiento, confirmada por cultivo o diagnosticada clínicamente.
    b. Confirmación de resistencias a INH o rifampicina en el caso índice en pacientes que sean incluidos como contactos previamente a la obtención de las resultados de susceptibilidad.
    c. Interrupción debido a efecto adverso al tratamiento, incluyendo afectos adversos grado 3 o toxicidad superior.
    d. Muerte por cualquier causa.
    e. Pérdida al seguimiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 16 weeks after the first study dose
    En 16 semanas desde la toma de la primera dosis.
    E.5.2Secondary end point(s)
    1. Rates of treatment completion by study arm
    2. Patterns of adherence for participants who complete and who fail to complete therapy
    3. The availability and acceptability of SMS reminders in all participants enrolled
    4. The effectiveness of SMS reminders in participants randomized to SAT with weekly SMS
    5. Resistance to study medications in isolates of M. tuberculosis from study subjects who develop active TB during or after treatment
    6. Patient time and costs associated with adverse events
    1. Tasas de tratamiento completado por rama
    2. Patrones de adherencia en participantes que completan y en los que no completan el tratamiento.
    3. Disponibilidad y aceptación de recordatorios SMS de todos los pacientes incluidos
    4. Efectividad de los recordatorios SMS en pacientes aleatorizados a la rama de AA con recordatorio SMS semanal.
    5. Resistencias a medicaciones del estudio en cepas de M. tuberculosis de participantes que desarrollen TB activa durante o tras el tratamiento.
    6. Costes y gasto en tiempo del paciente asociados a efectos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 2 years after the first study dose
    En 2 años desde la toma de la primera 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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Adherence study
    Estudio de adherencia
    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
    Auto-administrado vs Tratamiento Directamente Observado (TDO)
    Self-administered vs Directly Observed Therapy (DOT)
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    China
    South Africa
    United States
    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
    Last visit of the last subject undergoing the trial
    Última visita del último sujeto del estudio
    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: 899
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 999
    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)
    NA
    NA
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
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