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    Summary
    EudraCT Number:2017-001762-13
    Sponsor's Protocol Code Number:747-401
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-06-20
    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 number2017-001762-13
    A.3Full title of the trial
    A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
    Estudio de fase IV, doble ciego, aleatorizado y controlado con placebo para evaluar la farmacocinética y la seguridad del ácido obeticólico en pacientes con colangitis biliar primaria y disfunción hepática moderada o grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial where neither the doctor, patient or sponsor know whether a
    placebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body.
    Un ensayo clínico en el que ni el médico, ni el paciente ni el promotor saben si se está administrando un placebo o el medicamento activo al paciente con cirrhosis, para ver si el medicamento es seguro en el tratamiento de esa enfermedad y para ver cómo se absorbe el medicamento del estudio, se distribuye a través del cuerpo y se excreta fuera del cuerpo.
    A.4.1Sponsor's protocol code number747-401
    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 SponsorIntercept Pharmaceuticals, Inc.
    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 supportIntercept Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINC Research, LLC
    B.5.2Functional name of contact pointSusanna Giorgi
    B.5.3 Address:
    B.5.3.1Street AddressVicolo del Caldo, 36
    B.5.3.2Town/ citySaronno (VA)
    B.5.3.3Post code21047
    B.5.3.4CountryItaly
    B.5.4Telephone number003491 630 74 47
    B.5.6E-mailsusanna.giorgi@syneoshealth.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 Ocaliva
    D.2.1.1.2Name of the Marketing Authorisation holderIntercept Pharma, Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/753
    D.3 Description of the IMP
    D.3.1Product nameObeticholic Acid
    D.3.2Product code INT-747, OCA
    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 INNobeticholic acid
    D.3.9.1CAS number 459789-99-2
    D.3.9.2Current sponsor code6-ECDCA
    D.3.9.3Other descriptive name6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
    D.3.9.4EV Substance CodeSUB91981
    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) 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 Ocaliva
    D.2.1.1.2Name of the Marketing Authorisation holderIntercept Pharma, Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/753
    D.3 Description of the IMP
    D.3.1Product nameObeticholic Acid
    D.3.2Product code INT-747, OCA
    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 INNobeticholic acid
    D.3.9.1CAS number 459789-99-2
    D.3.9.2Current sponsor code6-ECDCA
    D.3.9.3Other descriptive name6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
    D.3.9.4EV Substance CodeSUB91981
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
    Colangitis biliar primaria y disfunción hepática moderada o grave
    E.1.1.1Medical condition in easily understood language
    Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
    Colangitis biliar primaria y disfunción hepática moderada o grave
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the PK of OCA and its conjugates, glyco-OCA and tauro-OCA, and OCA metabolite glucuronide compared with placebo. To evaluate the safety and tolerability of OCA treatment compared with placebo
    Evaluar la FC de OCA y sus conjugados, glyco-OCA y tauro-OCA, y glucurónido de metabolito de OCA en comparación con placebo. Evaluar la seguridad y tolerabilidad del tratamiento con OCA en comparación con placebo
    E.2.2Secondary objectives of the trial
    To evaluate the effect of OCA treatment compared to placebo on:
    − The MELD score and its components
    − CP score and its components
    − Liver biochemistry including total and direct bilirubin, alkaline phosphatase (ALP), and aminotransferases (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and gamma glutamyl transaminase [GGT]), international normalized ratio (INR), creatinine, albumin, platelets
    − Biomarkers of bile acid synthesis and homeostasis including fibroblast growth factor 19 (FGF-19), 7α-hydroxy-4-cholesten-3-one (C4), and plasma bile acids
    Evaluar el efecto del tratamiento con OCA en comparación con el placebo en:
    - La puntuación MELD y sus componentes
    - Puntuación CP y sus componentes
    - Bioquímica hepática que incluye bilirrubina total y directa, fosfatasa alcalina (ALP) y aminotransferasas (alanina aminotransferasa [ALT], aspartato aminotransferasa [AST] y gamma glutamil transaminasa [GGT]), índice internacional normalizado (INR), creatinina, albúmina, plaquetas
    - Biomarcadores de la síntesis y homeostasis de los ácidos biliares, incluido el factor de crecimiento fibroblástico 19 (FGF-19), 7α-hidroxi-4-colesten-3-ona (C4) y los ácidos biliares plasmático.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A definite or probable diagnosis of PBC (consistent with American Association for the Study of Liver Diseases [AASLD] and European Association for the Study of the Liver [EASL] Practice Guidelines [Lindor 2009, EASL 2009]), defined as having ≥2 of the following 3 diagnostic factors:
    − History of elevated ALP levels for at least 6 months
    − Positive antimitochondrial antibody (AMA) titer or if AMA negative or low titer (≤1:80), PBC-specific antibodies (anti-GP210 and/or anti-SP100) and/or antibodies against the major M2 components (PDC-E2, 2-oxo-glutaric acid dehydrogenase complex)
    − Liver biopsy consistent with PBC (collected at any time prior to Screening)
    2. Evidence of cirrhosis including at least one of the following:
    − Biopsy results consistent with PBC Stage 4
    − Liver stiffness as assessed by TE Value ≥16.9 kPa
    − Clinical evidence in the absence of acute liver failure consistent with cirrhosis including: gastroesophageal varices, ascites, radiological evidence of cirrhosis (nodular liver or enlargement of portal vein and splenomegaly)
    − Combined low platelet count (<140 000/mm3) with:
    − persistent decrease in serum albumin, or
    − elevation in prothrombin time /INR (not due to antithrombotic agent use), or
    − elevated bilirubin (2× ULN)
    3. Satisfy the criteria of the modified CP classification for hepatic impairment during Screening:
    − Moderate: CP-B (Scores 7 to 9) or
    − Severe: CP-C (Scores 10 to 12)
    4. MELD score of 6 to 24 at Screening
    5. Taking UDCA for at least 12 months (stable dose for ≥3 months) prior to Day 1, or unable to tolerate or unresponsive to UDCA (no UDCA for ≥3 months)
    1. Un diagnóstico claro o probable de CBP (coherente con la Asociación Americana para el Estudio de
    Enfermedades Hepáticas [AASLD] y las directrices sobre prácticas de la Asociación Europea para el
    Estudio del Hígado [EASL]), definida como tener ≥ 2 de los siguientes 3 factores de diagnóstico:
    • Antecedentes de niveles elevados de FA durante al menos 6 meses
    • Presencia de anticuerpos antimitocondriales positivos (AAM) o si los AAM son negativos o de
    baja titulación (≤ 1:80), anticuerpos específicos de la CBP (anti-GP210 y/o anti-SP100) y/o
    anticuerpos contra los principales componentes de M2 (PDC-E2, complejo ácido 2-
    oxoglutárico deshidrogenasa)
    • Biopsia hepática compatible con CBP (obtenida en cualquier momento antes de la selección)
    2. Evidencia de cirrosis, que incluye al menos uno de los siguientes:
    • Resultados de la biopsia compatibles con el estadio 4 de la CBP
    • Rigidez hepática evaluada por un valor de TE ≥ 16,9 kPa
    • Evidencia clínica en ausencia de insuficiencia hepática aguda compatible con cirrosis, que incluye:
    varices gastroesofágicas, ascitis, indicios radiológicos de cirrosis (hígado nodular o agrandamiento
    de la vena porta y esplenomegalia)
    • Combinación de cifras bajas de plaquetas (< 140 000/mm3) con
     disminución persistente de la albúmina sérica, o
     elevación del tiempo de protrombina/INR (no debido al uso de fármacos antitrombóticos), o
     bilirrubina elevada (2 x LSN)
    3. Cumplir los criterios de la clasificación CP modificada para la insuficiencia hepática durante la
    selección:
    • Moderado: CP-B (puntuaciones de 7 a 9) o
    • Grave: CP-C (puntuaciones de 10 a 12)
    4. Puntuación MELD de 6 a 24 en la selección
    5. Tomar UDCA durante al menos 12 meses (dosis estable durante ≥ 3 meses) antes del día 1 o
    incapacidad para tolerar o no responder a UDCA (sin UDCA durante ≥ 3 meses)
    E.4Principal exclusion criteria
    1. Non-cirrhotic or cirrhotic CP-A (Mild; Score 5 to 6)
    2. History of liver transplant or organ transplant
    3. History of alcohol or drug abuse within 12 months prior to Screening
    4. Current hepatic encephalopathy (as defined by a West Haven score of
    ≥2)
    5. History or presence of other concomitant liver diseases including:
    • Hepatitis C virus infection and RNA positive
    • Active hepatitis B infection; however, patients who have seroconverted
    (hepatitis B surface antigen and hepatitis B e antigen negative) may be
    included in this study after consultation with the Medical Monitor
    • Primary sclerosing cholangitis
    • Alcoholic liver disease
    • Definite autoimmune liver disease or overlap hepatitis
    • Gilbert's Syndrome
    6. In the opinion of the Investigator, fluctuating or rapidly deteriorating
    hepatic function prior to randomization
    1. CP-A cirrótica o no cirrótica (leve; puntuación de 5 a 6)
    2. Antecedentes de trasplante de hígado o trasplante de órganos
    3. Antecedentes de alcoholismo o toxicomanía en los 12 meses anteriores a la selección.
    4. Encefalopatía hepática actual (definida por una puntuación de West Haven ≥ 2)
    5. Antecedentes o presencia de otra hepatopatía concomitante como las siguientes:
    • Infección por el virus de la hepatitis C y positivo para ARN
    • Infección activa por hepatitis B; sin embargo, los pacientes que han respondido (antígeno de superficie de la hepatitis B y antígeno e de hepatitis C negativo) pueden ser incluidos en este estudio después de consultarlo con el monitor médico.
    • Colangitis esclerosante primaria
    • Enfermedad alcohólica del hígado
    • Enfermedad hepática autoinmunitaria clara o hepatitis superpuesta
    • Síndrome de Gilbert
    6. En opinión del investigador, fluctuaciones o deterioro rápido de la función hepática antes de la aleatorización
    E.5 End points
    E.5.1Primary end point(s)
    Primary Objective:
    • To evaluate the pharmacokinetics (PK) of OCA and its conjugates, glyco-OCA and tauro-OCA, and metabolite OCA glucuronide compared with placebo
    • To evaluate the safety and tolerability of OCA treatment compared with placebo
    Objetivo primario:
    • Evaluar la farmacocinética (PK) de OCA y sus conjugados,
    glyco-OCA y tauro-OCA, y metabolito OCA glucurónido en comparación
    con placebo
    • Evaluar la seguridad y la tolerabilidad del tratamiento con OCA en comparación con
    Placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 48
    Semana 48
    E.5.2Secondary end point(s)
    • To evaluate the effect of OCA treatment compared to placebo on:
    − The model of end stage liver disease (MELD) score and its components
    − Child-Pugh (CP) score and its components
    − Liver biochemistry including total and direct bilirubin, alkaline
    phosphatase (ALP), and aminotransferases (alanine aminotransferase
    [ALT], aspartate aminotransferase [AST], and gamma glutamyl
    transaminase [GGT]), international normalized ratio (INR), creatinine,
    albumin, platelets
    − Biomarkers of bile acid synthesis and homeostasis including fibroblast
    growth factor 19 (FGF-19), 7α-hydroxy-4-cholesten-3-one (C4), and
    plasma bile acids

    • Evaluar el efecto del tratamiento con OCA en comparación con el placebo en:
    - El modelo de puntuación de enfermedad hepática en etapa terminal (MELD) y sus componentes
    - Puntuación Child-Pugh (CP) y sus componentes
    - Bioquímica hepática que incluye bilirrubina total y directa, fosfatasa alcalina (ALP) y aminotransferasas (alanina aminotransferasa [ALT], aspartato aminotransferasa [AST] y gamma glutamil transaminasa [GGT]), índice internacional normalizado (INR), creatinina, albúmina, plaquetas
    - Biomarcadores de la síntesis y homeostasis de los ácidos biliares, incluido el factor de crecimiento fibroblástico 19 (FGF-19), 7α-hidroxi-4-colesten-3-ona (C4) y los ácidos biliares plasmáticos
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 48
    Semana 48
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Argentina
    Australia
    Belgium
    Brazil
    Estonia
    Germany
    Hungary
    Italy
    Lithuania
    Spain
    Switzerland
    United Kingdom
    United States
    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
    Last Visit of Last Subject
    Última visita del ultimo paciente
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 50
    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)
    None
    Ninguno
    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 Decision2018-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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