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    Summary
    EudraCT Number:2008-003633-24
    Sponsor's Protocol Code Number:UITB-Study-29
    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:2008-08-07
    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 number2008-003633-24
    A.3Full title of the trial
    Evaluation of a rifapentine-containing regimen for intensive phase treatment of pulmonary tuberculosis






    Evaluación de una Pauta con Rifapentina para la Fase Intensiva del tratamiento de la Tuberculosis Pulmonar
    A.3.2Name or abbreviated title of the trial where available
    Study 29
    A.4.1Sponsor's protocol code numberUITB-Study-29
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTB Investigation Unit 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Rifadin
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameRifadin
    D.3.2Product code 0068-0510
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRIFAMPICIN
    D.3.9.1CAS number 13292461
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number600
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Priftin
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePriftin
    D.3.2Product code 0088-2100
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 61379655
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number600
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    To compare two treatments for Pulmonary Tuberculosis

    Comparar dos tratamientos para la tuberculosis pulmonar
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037440
    E.1.2Term Pulmonary tuberculosis
    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 antimicrobial activity and safety of standard daily regimen comprised of rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE).

    Comparar la actividad antimicrobiana y la seguridad de una pauta diaria estándar de rifampicina (aproximadamente de 10 mg/Kg/por dosis) + isoniacida + pirazinamida + etambutol (RHZE) frente a una pauta experimental de rifapentina (aproximadamente de 10 mg/Kg/por dosis) + isoniazida + pirazinamida + etambutol (PHZE)
    E.2.2Secondary objectives of the trial
    To determine and compare?
    ..the time to culture-conversion.
    ..patients with adverse reactions.
    ..the correlation of the liquid culture growth index and other biomarkers with time to culture conversion and treatment failure.
    ..adverse events and culture conversion rates among HIV-infected vs. HIV-uninfected patients.To store serum for assessment of biomarkers of TB treatment response and hypersensitivity.

    Determinar y comparar...
    ..el tiempo de conversión del cultivo del esputo.
    ..pacientes con acontecimientos adversos.
    ..la correlación del crecimiento en los medios líquidos y otros biomarcadores con el tiempo de conversión del cultivo y el fracaso del tratamiento.
    ..la proporción de los acontecimientos adversos y la tasa de conversión del cultivo entre los pacientes VIH positivos y VIH negativos.Almacenar suero para valoración de biomarcadores de respuesta al tratamiento de la TB y de hipersensibilidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Suspected pulmonary tuberculosis.
    2. Willingness to have HIV testing performed.
    3. 5 (five) or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding initiation of study drugs.
    4. 7 (seven) or fewer days of fluoroquinolone therapy in the 30 days preceding initiation of study drugs.
    5. Age > 18 years
    6. Karnofsky score of at least 60
    7. Signed informed consent
    8. Women of child-bearing potential must agree to practice an adequate method of birth control or to abstain from heterosexual intercourse.
    9. Laboratory parameters done < 14 days prior to, enrollment:
    Serum or plasma ALT activity ? 3 times the upper limit of normal
    Serum or plasma total bilirubin level ? 2.5 times the upper limit of normal
    Serum or plasma creatinine level ? 2 times the upper limit of normal
    Complete blood count with hemoglobin level of at least 7.0 g/dL and platelet count of at least 100,000/mm3
    Negative pregnancy test

    1. Sospecha de tuberculosis pulmonar.
    2. Compromiso de acceder a realizarse una prueba de VIH.
    3. Cinco (5) o menos días de terapia múltiple anti-tuberculosa en los 6 meses previos a la inclusión.
    4. Siete (7) o menos días de tratamiento con una fluoroquinolona durante 30 días previos a la inclusión.
    5. Edad mayor de 18 años.
    6. puntuación en la escala de Karniosfky de 60 o más
    7. Firma del consentimiento informado.
    8. Las mujeres en edad fértil deben acceder a usar un método anticonceptivo adecuado o abstenerse de mantener relaciones sexuales heterosexuales.
    9. Análisis realizados < 14 días antes del cribado,
    AST en suero ? 3 veces el límite superior de la normalidad.
    bilirrubina total en suero £ 2,5 veces el límite superior de la normalidad.
    Nivel de creatinina en suero £ 2 veces el límite superior de la normalidad.
    Hemograma completo con nivel de hemoglobina de 7,0 g/dL o superior y recuento de plaquetas de 100.000/mm3 o superior.
    Prueba de embarazo negativa.
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding
    2. Known intolerance or allergy to any of the study drugs
    3. Concomitant disorders or conditions for which isoniazid, rifamycins, pyrazinamide , or ethambutol are contraindicated.
    4. Current or planned therapy, during the intensive phase of TB therapy, with combination antiretroviral therapy for HIV, or with cyclosporine or tacrolimus.
    5. Pulmonary silicosis
    6. Central nervous system TB
    7. Weight < 40 kg

    1. Lactancia materna.
    2. Intolerancia conocida a cualquiera de los fármacos del estudio.
    3. Enfermedad concomitante o condición que contraindique el uso de rifamicinas, isoniacida, pirazinamida o etambutol.
    4. Tratamiento antirretroviral actual o previsto durante la fase intensiva del tratamiento antituberculoso o con cicloserina o tacrolimus. Silicosis pulmonar.
    5. Tuberculosis del SNC.
    6. Peso menor de 40 kg
    E.5 End points
    E.5.1Primary end point(s)
    1. The proportion of patients, by regimen, having negative sputum cultures at completion of eight weeks (40 doses) of treatment.
    2. The proportion of patients, by regimen, who permanently discontinue the assigned study treatment for any reason during the first eight weeks

    1. La proporción de pacientes en cada pauta que tienen cultivo de esputo negativos a las 8 semanas (40 dosis) de tratamiento.
    2. La proporción de pacientes en cada pauta que discontinúan permanentemente su tratamiento asignado por cualquier razón durante las primeras 8 semanas.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    8 weeks for the intensive treatment phase (study phase)
    6 to 9 months for the completion of the treatment
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 480
    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 Decision2009-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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