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    Summary
    EudraCT Number:2018-002575-17
    Sponsor's Protocol Code Number:747-213
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-07-26
    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 number2018-002575-17
    A.3Full title of the trial
    A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary
    Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
    Estudio en fase II con doble enmascaramiento, aleatorizado de grupos paralelos para evaluar la eficacia, la
    seguridad y la tolerabilidad del ácido obeticólico administrado como monoterapia o en combinación con
    bezafibrato en sujetos con colangitis biliar primaria que tuvieron una respuesta insuficiente al ácido
    ursodesoxicólico o que no pudieron tolerarlo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).
    Estudio para determinar si el fármaco en investigación ácido obeticólico (también conocido como OCA) en combinación con el fármaco en investigación bezafibrato (BZF), tiene un efecto sobre la colangitis biliar primaria (también conocida como cirrosis biliar primaria o PBC).
    A.4.1Sponsor's protocol code number747-213
    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 organisationSyneos Health
    B.5.2Functional name of contact pointPawel Waszka
    B.5.3 Address:
    B.5.3.1Street Address1030 Sync Street
    B.5.3.2Town/ cityMorrisville, North Carolina
    B.5.3.3Post code27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+48222564220
    B.5.6E-mailpawel.waszka@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 10mg
    D.2.1.1.2Name of the Marketing Authorisation holderIntercept Pharma International 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 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderIntercept Pharma International 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.IMP: 3
    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 Bezalip
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS GROUP PTC EHF
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameBezafibrate IR
    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 INNBEZAFIBRATE
    D.3.9.1CAS number 41859-67-0
    D.3.9.3Other descriptive nameBezafibrate, Beza, BZF, Bezalip
    D.3.9.4EV Substance CodeSUB05810MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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: 4
    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 Bezalip mono
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS GROUP PTC EHF
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameBezafibrate SR
    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 INNBEZAFIBRATE
    D.3.9.1CAS number 41859-67-0
    D.3.9.3Other descriptive nameBezafibrate, Beza, BZF, Bezalip mono
    D.3.9.4EV Substance CodeSUB05810MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    D.8 Placebo: 2
    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 (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
    Colangitis biliar primaria (CBP) en pacientes con una respuesta insuficiente al ácido ursodesoxicólico o que no pudieron tolerarlo
    E.1.1.1Medical condition in easily understood language
    Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
    Colangitis biliar primaria (CBP) en pacientes con una respuesta insuficiente al ácido ursodesoxicólico o que no pudieron tolerarlo
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10036680
    E.1.2Term Primary biliary cirrhosis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to OCA alone in subjects with PBC who had an inadequate response or who were unable to tolerate ursodeoxycholic acid (UDCA).
    El objetivo principal es evaluar los efectos de la combinación de AOC y BZF en la fosfatasa alcalina (FA) en
    comparación con AOC solo en sujetos con colangitis biliar primaria (CBP) que tuvieron una respuesta insuficiente al ácido ursodesoxicólico (AUDC) o que no pudieron tolerarlo.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the effects of the combination of OCA and BZF in comparison to OCA alone in subjects with PBC who had an inadequate response or who were unable to tolerate UDCA on the following:
    - Safety and tolerability
    - Response and normalization rates of biochemical disease markers
    - Disease-specific symptoms as assessed by health-related quality of life questionnaires
    - Biomarkers of bile acid synthesis and homeostasis
    Los objetivos secundarios son evaluar los efectos de la combinación de AOC y BZF en comparación con AOC solo en sujetos con
    colangitis biliar primaria (CBP) que tuvieron una respuesta insuficiente con el AUDC o que no pudieron tolerarlo con respecto a lo siguiente:
    • Seguridad y tolerabilidad
    • Tasas de respuesta y normalización de los marcadores bioquímicos de la enfermedad
    • Síntomas específicos de la enfermedad mediante evaluación con cuestionarios de calidad de vida relacionada con la salud
    • Biomarcadores de síntesis de los ácidos biliares y homeostasia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - A definite or probable diagnosis of PBC (consistent with the European Association for the Study of the Liver [EASL] Practice Guidelines and the American Association for the Study of Liver Diseases; [Lindor 2009a, EASL 2017])
    - Qualifying ALP and bilirubin liver biochemistry values
    - Age ≥18 years
    - Taking UDCA for at least 12 months (stable dose for ≥3 months) before Day 1 or unable to tolerate or unresponsive to UDCA (no UDCA for ≥3 months) before Day 1
    -Un diagnóstico claro o probable de CBP (en línea con las directrices prácticas de la Asociación Europea para el Estudio del Hígado [European Association for the Study of the Liver, EASL] y la Asociación Americana para el Estudio de Enfermedades Hepáticas [American Association for the Study of Liver Diseases]; [Lindor 2009a, EASL 2017]
    -Valores cualificados de FA y bilirubina en bioquímica hepatica
    -Edad ≥ 18 años.
    -Tomar AUDC durante al menos 12 meses (dosis estable durante ≥ 3 meses) antes del día 1 o incapacidad para tolerar o no responder a AUDC (sin AUDC durante ≥3 meses) antes del día 1
    E.4Principal exclusion criteria
    - History or presence of other concomitant liver diseases
    - Presence of clinical complications of PBC or clinically significant (CS) hepatic decompensation
    - Current or history of gallbladder disease with or without cholelithiasis
    - Severe renal failure (serum creatinine >1.5 mg/100 mL (>135 μmol/L); creatinine clearance <60 mL/min) or undergoing dialysis
    - Severe pruritus, or required systemic treatment for pruritus (eg, with bile acid sequestrants or rifampicin) within 2 months of Day 1
    - History of known or suspected CS hypersensitivity to OCA, BZF, or other fibrates or any of their components
    - Was treated with commercially available OCA or participated in a previous study involving OCA within 1 year before Screening or plans to use commercially available OCA during the study
    - Is unable to tolerate BZF or other fibrates, was treated with commercially available fibrates or participated in a previous study involving fibrates within 3 months before Screening, or plans to use commercially available fibrates during the study

    Note: Other protocol defined Inclusion/Exclusion criteria may apply
    -Antecedentes o presencia de otras hepatopatías concomitantes.
    -Presencia de complicaciones clínicas de la CBP o descompensación hepática clínicamente significativa
    -Antecedentes o afectación actual de la vesícula con o sin colelitiasis
    -Insuficiencia renal grave (creatinina en suero >1,5 mg/100 ml (>135 μmol/l); aclaramiento de la creatinina <60 ml/min) o recibiendo dialysis.
    -Prurito intenso, como se define en la tabla 10, o tratamiento sistémico requerido para el prurito (p. ej., con secuestrantes de ácidos biliares o rifampicina) en los 2 meses previos al día 1.
    -Antecedentes de hipersensibilidad clínicamente significativa conocida o sospechada al AOC o a otros fibratos o a cualquiera de sus components.
    -Tratamiento con AOC disponible comercialmente o participación en un estudio anterior con AOC dentro del año anterior a la selección o planes de usar AOC disponible comercialmente durante el studio.
    -No puede tolerar BZF u otros fibratos, recibió tratamiento con fibratos disponibles comercialmente o participó en un estudio anterior con fibratos dentro de los 3 meses anteriores a la selección o planea usar ibratos disponibles comercialmente durante el studio.

    Nota: Pueden aplicar otros criterios de inclusion/exclusion definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in ALP from baseline to Week 12 in the DB Treatment Period
    Cambio absoluto en la FA entre el momento inicial y la semana 12 en el período de tratamiento con DE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    Semana 12
    E.5.2Secondary end point(s)
    - Safety and tolerability
    - Response and normalization rates of biochemical disease markers
    - Disease-specific symptoms as assessed by health-related quality of life questionnaires
    - Biomarkers of bile acid synthesis and homeostasis
    -Seguridad y tolerancia
    -Tasas de respuesta y normalización de los marcadores bioquímicos de la enfermedad
    -Síntomas específicos de la enfermedad mediante evaluación con cuestionarios de calidad de vida relacionada con la salud
    -Biomarcadores de síntesis de los ácidos biliares y homeostasia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to End of study
    Desde el momento inicial hasta el final del studio.
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA38
    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
    Australia
    Austria
    Belgium
    Croatia
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Korea, Republic of
    Latvia
    Lithuania
    Netherlands
    Norway
    Poland
    Slovakia
    Slovenia
    Spain
    Sweden
    United Kingdom
    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
    LVLS
    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 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 54
    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
    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 Decision2019-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-19
    P. End of Trial
    P.End of Trial StatusRestarted
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