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    Summary
    EudraCT Number:2007-001424-12
    Sponsor's Protocol Code Number:747-201
    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:2008-05-22
    Trial results View 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 number2007-001424-12
    A.3Full title of the trial
    Estudio de la monoterapia INT-747 (6-ECDCA) en pacientes con
    cirrosis biliar primaria

    A Study of INT-747 (6-ECDCA) Monotherapy in Patients
    with Primary Biliary Cirrhosis
    A.4.1Sponsor's protocol code number747-201
    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 SponsorIntercept Pharmaceuticals
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 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 No
    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 nameINT-747
    D.3.2Product code INT-747
    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 INN3α,7α-dihydroxy-6α-ethyl-5βcholan-24-oic acid
    D.3.9.1CAS number 459789-99-2
    D.3.9.2Current sponsor code6-ECDCA or INT-747
    D.3.9.3Other descriptive name6α-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typesintético químico
    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 No
    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 nameINT-747
    D.3.2Product code INT-747
    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 INN3α,7α-dihydroxy-6α-ethyl-5βcholan-24-oic acid
    D.3.9.1CAS number 459789-99-2
    D.3.9.2Current sponsor code6-ECDCA or INT-747
    D.3.9.3Other descriptive name6α-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 Yes
    D.3.11.13.1Other medicinal product typesintético químico
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    cirrosis biliar primaria
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10004661
    E.1.2Term Biliary cirrhosis primary
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    En pacientes con cirrosis biliar primaria (PBC), para evaluar los efectos de INT-747 en:
    - Niveles de fosfatasa alcalina (AP)
    - Seguridad
    E.2.2Secondary objectives of the trial
    En pacientes con cirrosis biliar primaria (PBC), para evaluar los efectos de INT-747 en:
    - Lesión hepatocelular y función del hígado
    - Síntomas generales de salud y específicos de la enfermedad
    - Bioindicadores de inflamación hepática y fibrosis
    - Plasma a través de las concentrationes de INT-747 y sus metabolitos principales, conocidos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Se requiere que los pacientes cumplan con el siguiente criterio para poder ser incluídos en
    el estudio:
    • Hombre o mujer de 18 a 70 años de edad.
    • Las pacientes femeninas deberán ser quirúrgicamente estériles o estar en la post
    menopausia.
    • Los pacientes masculinos deberán estar dispuestos a usar 2 métodos de
    contraceptivos con todas sus parejas sexuales durante el estudio y en los 90 días
    después del final de la dosificación, a menos que hayan tenido una vasectomía.
    • PBC comprobada o posible, demostrada por el paciente, quien presenta por lo
    menos 2 de los 3 siguientes factores de diagnóstico:
    o Historial de incremento en los niveles de AP por un mínimo de 6 meses
    antes del Día 0
    o Título de AMA positivo (Título>1:40 en inmunofluorescencia or M2
    positivo en ELISA) o anticuerpos antinucleares específicos de PBC (punto
    antinuclear y borde nuclear positivo)
    o Biopsia de hígado consistente con PBC
    • Valor de selección de AP entre 1.5 and 10 × ULN.
    • Dispuesto y capacitado para dar un consentimiento informado por escrito.
    E.4Principal exclusion criteria
    Los pacientes con las siguientes características serán excluídos del estudio:
    • Pacientes femeninas de edad fértil.
    • Administración de los siguientes medicamentos en cualquier momento durante los
    3 meses anteriores a la selección del estudio: ácido ursodeoxicólico (UDCA,
    Urso®), colchicine, methotrexate, azathioprine, o corticoesteroides sistémicos.
    • Selección conjugada (directa) de bilirrubina >2 × ULN.
    • Selección de ALT or AST >5 × ULN.
    • Selección de >133 µmol/L (1.5 mg/dL).
    • Historial o presencia de decompensación hepática (p.ej. sangrados varicosos,
    encefalopatía o ascitis deficientemente controlada.)
    • Historial o presencia de otras enfermedades del hígado concomitantes, incluyendo
    hepatitis debido a la infección del virus de hepatitis B o C (HCV, HBV) colangitis
    esclerosante primaria (PSC), enfermedad del hígado alcohólico, enfermedad
    definitiva hepática autoinmune o biopsia que prueba esteatohepatitis no alcohólica
    (NASH).
    • Historial conocido de infección del virus de inmunodeficiencia humana (HIV)
    • Historial o presencia de cualquier otra enfermedad o condición, la cual se sabe
    que interfiere con la absorción, distribución, metabolismo o excreción de
    medicamentos incluyendo el metabolismo de sales biliares en el intestino grueso
    (por ejemplo, enfermedad inflamatoria del intestino.)
    • Otras condiciones médicas clínicamente significantes, incluyendo la insuficiencia
    renal.
    • Otras condiciones médicas que no están bien controladas o para las cuales se
    anticipe que habrá cambio en las necesidades de medicamentos durante el estudio.
    Los medicamentos concomitantes deberán ser estables durante 14 días anteriores
    a la primera dosis de medicamento del estudio, y deberá esperarse que se
    mantengan estables durante el curso del estudio.
    • Historial del abuso de alcohol (definido como consumo de más de 210 mL de
    alcohol por semana o el equivalente de 14 copas de vino de 4 onzas, o 14 latas o
    botellas de cerveza o vino mezclado con jugo (wine coolers) de 12 onzas u otro
    abuso de substancia durante el año anterior.
    • Participación en otro estudio de medicamento experimental, biológico o de un
    dispositivo médico dentro de los 30 días antes del Día 0.
    • Un historial de falta de cumplimiento con respecto a regímenes médicos, o
    pacientes los cuales son considerados como posiblemente no confiables .
    • Donación de sangre o plasma durante los 30 días anteriores a la dosificación.
    • Inestabilidad o incompetencia mental de tal manera que la validez del
    consentimiento informado o el cumplimiento con el estudio sean inciertos.
    E.5 End points
    E.5.1Primary end point(s)
    La valorización final de la eficacia primaria es el efecto deINT-747 sobre los niveles séricos de AP.
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Como final del ensayo se considerá la última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 120
    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 Decision2008-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-25
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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