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    Summary
    EudraCT Number:2016-002416-41
    Sponsor's Protocol Code Number:201000
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002416-41
    A.3Full title of the trial
    A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.
    (GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response).
    Studio randomizzato, in doppio cieco, multi-dose, controllato con placebo, per valutare efficacia, sicurezza e tollerabilit¿ della somministrazione di GSK2330672 nel trattamento del prurito in pazienti
    con colangite biliare primitiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis
    Studio dose-risposta di GSK2330672 nel trattamento del prurito in pazienti con colangite biliare primitiva.
    A.3.2Name or abbreviated title of the trial where available
    Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cho
    Studio dose-risposta di GSK2330672 nel trattamento del prurito in pazienti con colangite biliare pri
    A.4.1Sponsor's protocol code number201000
    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 SponsorGLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
    B.1.3.4CountryUnited Kingdom
    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 supportGSK R&D
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research and Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number04402089904466
    B.5.5Fax number.
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 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 nameGSK2330672
    D.3.2Product code GSK2330672
    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 INNGSK2330672
    D.3.9.1CAS number 1345983-37-0
    D.3.9.2Current sponsor codeGSK2330672
    D.3.9.4EV Substance CodeSUB121295
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 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 nameGSK2330672
    D.3.2Product code GSK2330672
    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 INNGSK2330672
    D.3.9.1CAS number 1345983-37-0
    D.3.9.2Current sponsor codeGSK2330672
    D.3.9.4EV Substance CodeSUB121295
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 (PBC)
    Colangite biliare primitiva
    E.1.1.1Medical condition in easily understood language
    Itch due to primary biliary cholangitis (PBC).
    Prurito dovuto a colangite biliare primitiva
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037087
    E.1.2Term Pruritus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10008604
    E.1.2Term Cholangitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ¿ To investigate the dose response of oral GSK2330672 on itch in PBC patients with moderate to severe pruritus at Baseline.
    Analizzare il rapporto dose-risposta di GSK2330672 orale sul prurito in pazienti con PBC che presentano un prurito da moderato a grave al basale.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    ¿ To characterize the effects of GSK2330672 compared to placebo on impact of symptoms and quality of life in PBC patients with moderate to severe pruritus at Baseline.
    ¿To evaluate the effects of GSK2330672 compared to placebo on markers of disease among participants at high risk of PBC progression (i.e., those with serum ALP concentrations <1.67xULN and/or total bilirubin concentrations >ULN at Day 1).
    (Please refer to study protocol 201000 for other Secondary Objectives)
    - Caratterizzare gli effetti di GSK2330672 rispetto al placebo in termini di impatto sui sintomi e sulla qualit¿ di vita in pazienti con PBC che presentano un prurito da moderato a grave al basale.
    - Valutare gli effetti di GSK2330672 rispetto al placebo sui marcatori della malattia tra i partecipanti ad alto rischio di progressione della PBC (ossia, quelli con concentrazioni sieriche della fosfatasi alcalina [ALP] ¿1,67 x limite superiore della norma [ULN] e/o concentrazioni di bilirubina totale >ULN il Giorno 1). (perfavore riferirsi al protocollo 201000 o relativa sinossi per gli altri obiettivi secondari)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age
    1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
    Type of Participant and Disease Characteristics
    2. Participants who have proven PBC, as demonstrated by having at least 2 of the following:
    • History of sustained increased ALP levels >upper limit of normal (ULN) first recognized at least 6 months prior to the Screening Visit (Note: Sustained ALP elevations at the time of Screening is not required, recognizing that the ALP may have decreased after institution of UDCA therapy as described in inclusion number 4).
    • Documented positive anti-mitochondrial antibody (AMA) titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and/or nuclear rim positive).
    • Liver biopsy (at any time in the past) consistent with PBC.
    3.Participants must rate their itch severity as being =4 on a 0 to 10-point scale for
    the majority of time (at least half the days, as recalled by the participant) during
    the 8 weeks prior to the Screening Visit. Periods of low itch or no itch are
    acceptable as long as the worst daily itch score is =4 on the majority of days.
    4. Participants who are currently taking UDCA should be on stable doses of UDCA for >8 weeks at time of screening. Participants not taking UDCA due to intolerance may be enrolled 8 weeks after their last dose of UDCA.
    Note: no changes or discontinuation is permitted until completion of the Main Study Period.
    Sex
    5. Male and/or female:
    a. Female participants:
    A female participant is eligible to participate if she is not pregnant (see Appendix 2 of study protocol), not breastfeeding, and at least one of the following conditions applies:
    (i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 of study protocol
    OR
    (ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 of study protocol during the treatment period and until at least 4 weeks after the last dose of study treatment.
    Informed Consent
    6. Capable of giving signed informed consent as described in Appendix 3 of study protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
    I partecipanti solo elegibili allo studio solo se tutti i seguenti soddisfano tutti i seguenti criteri:
    1. Età compresa tra 18 e 80 anni, estremi inclusi, alla firma del consenso informato
    2. I partecipanti dovranno avere una PBC comprovata, dimostrata dalla presenza di almeno 2 dei seguenti criteri:
    • Storia di aumento sostenuto dei livelli di ALP > limite superiore della norma (ULN) rilevati per la prima volta almeno 6 mesi prima della visita di screening (NB: non sono richiesti aumenti sostenuti dell’ALP al momento dello screening, in quanto l’ALP potrebbe essersi ridotta in seguito alla terapia con acido ursodesossicolico (UDCA), come specificato nel criterio di inclusione numero 4).
    • Documentata titolazione positiva degli anticorpi anti-mitocondriali (AMA, titolazione > 1:40 all’immunofluorescenza o positività M2 al test ELISA) o degli anticorpi anti-nucleo PBC-specifici (positività degli anticorpi anti-nucleo di tipo punteggiato e/o di tipo periferico).
    • Biopsia epatica (in qualsiasi momento del passato) coerente con PBC
    3. I partecipanti devono classificare la gravità del loro prurito come = 4 su una scala da 0 a 10 punti per la maggior parte del tempo durante le 8 settimane precedenti la visita di screening. I periodi di scarso prurito o di assenza di prurito sono accettabili purché il punteggio del peggior prurito quotidiano sia = 4 per la maggior parte dei giorni.
    4. I partecipanti che stanno assumendo UDCA devono ricevere dosi stabili di UDCA da più di 8 settimane al momento dello screening. I partecipanti che non assumono UDCA per intolleranza possono essere arruolati 8 settimane dopo la loro ultima dose di UDCA. (Nota: non sono consentite modifiche o interruzione fino alla conclusione del periodo di studio principale).
    5. Maschi e femmine. Le femmine sono eleggibili se non sono in gravidanza o in allattamento e se almeno una delle seguenti condizioni risulta soddisfatta:
    • Non si tratta di una donna in età fertile secondo la definizione riportata nell’Appendice 2 del protocollo
    • Donna in età fertile che acconsente a seguire le linee guida sulla contraccezione riportate nell’Appendice 2 del protocollo durante il periodo di trattamento e fino ad almeno 4 settimane dopo l’ultima dose del trattamento in studio.
    6. Soggetti in grado di dare un consenso informato firmato, come descritto nell’Appendice 3 del protocollo che comprende la conformità con i requisiti e le restrizioni elencate nel ICF e in questo protocollo

    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. Screening total bilirubin >2x ULN. Isolated bilirubin >2x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
    2. Screening ALT or aspartate aminotransferase (AST) >6x ULN.
    3. Screening estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m² based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
    4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
    5. Presence of actively replicating viral hepatitis B or C (HBV, HCV) infection and/or confirmed hepatocellular carcinoma or biliary cancer.
    Note: Other hepatic conditions (e.g., primary sclerosing cholangitis (PSC), alcoholic liver disease, autoimmune hepatitis, non-alcoholic steatohepatitis [NASH] are permitted if PBC is the dominant liver injury in the investigator’s opinion.
    6. Current diarrhea.
    7. Current symptomatic cholelithiasis or inflammatory gall bladder disease. Participants with history of cholecystectomy =3 months before screening may be eligible for enrollment.
    8. Any current medical condition (e.g. psychiatric disorder, senility or dementia), which may affect the participant’s ability to comply with the protocol specified procedures.
    Prior/Concomitant Therapy
    9. Initiation or increase in dose of colchicine, methotrexate, azathioprine, or systemic corticosteroids in the 2 months prior to screening.
    Note: If a change in dose in any of these medications is anticipated during the course of the study, the participant should be excluded. [Rationale: Limited evidence indicates these drugs may alter disease progression in some PBC patients.]
    10. Initiation or increase in dose of bezafibrate or fenofibrate at any time during the 3 months prior to screening. Participants may join the study on stable doses of these medications, but no change or discontinuation is permitted until completion of the Main Study Period.
    11. Initiation or increase in dose of any of the following in the 8 weeks prior to screening: rifampicin, naltrexone, naloxone, nalfurafine, or sertraline. Participants may join the study on stable or decreased doses of these medications, but no change in dose is permitted until completion of the Main Study Period.
    12. Bile acid binding resin use: a participant must discontinue use of cholestyramine, colesevelam, colestipol or colestimide prior to the start of the Initial Study Period (no later than Day -2). Note: these drugs may be administered after completion of the Main Study Period, if clinically indicated.
    13. Obeticholic acid use: a participant must discontinue use of obeticholic acid at least 8 weeks prior to the start of the Initial Study Period and may not restart until after the end of the study.
    14. Administration of any other IBAT inhibitor in the 3 months prior to screening [Rationale: Effects of another IBAT inhibitor may influence pruritus.]
    Prior/Concurrent Clinical Study Experience
    15. Current enrollment or participation within the 8 weeks before start of the Initial Study Period, in any other clinical study involving an investigational study
    treatment.
    Diagnostic assessments
    16. QTc >480 msec
    NOTES:
    - The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method. It is
    either machine-read or manually over-read.
    - The specific formula used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulas cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial.
    17. History of sensitivity to the study treatment or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation in the study.
    18. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
    I partecipanti sono esclusi dallo studio se uno qualsiasi dei seguenti criteri si applicano:
    Condizione medica
    1. Bilirubina totale allo screening > 2 x ULN. È accettabile un livello isolato di bilirubina > 2 x ULN a condizione che la bilirubina sia frazionata e che la bilirubina diretta sia < 35%.
    2. ALT o AST allo screening > 6 x ULN.
    3. Velocità di filtrazione glomerulare stimata (eGFR) allo screening < 45 ml/min/1,73m2 in base all’equazione CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration).
    4. Precedenti di scompenso epatico (ad esempio sanguinamento da varici, encefalopatia o ascite).
    5. Presenza di infezione da virus dell’epatite B o C (HBV, HCV) attivamente replicante e/o carcinoma epatocellulare o cancro biliare confermato.
    Nota: altre condizioni epatiche (per es. colangite sclerosante primaria (Primary Sclerosing Cholangitis, PSC), epatopatia alcolica, epatite autoimmune, steatoepatite non alcolica (NASH) sono ammesse qualora la PBC sia il danno epatico dominante a giudizio dello sperimentatore.
    6. Attuale diarrea.
    7. Attuale colelitiasi o malattia infiammatoria sintomatica della colecisti. I partecipanti con colecistectomia eseguita = 3 mesi prima dello screening possono essere eleggibili per l’arruolamento.
    8. Qualsiasi condizione clinica attuale (ad es. disturbo psichiatrico, senilità o demenza) che potrebbe pregiudicare la capacità del partecipante di rispettare le procedure previste dal protocollo.
    Terapia precedente/concomitante
    9. Avvio o aumento della dose di colchicina, metotressato, azatioprina o corticosteroidi sistemici nei 2 mesi precedenti lo screening.
    Nota: nel caso in cui si preveda un cambiamento della dose di uno di questi farmaci durante il corso dello studio, il partecipante deve essere escluso. [Razionale: evidenze limitate indicano che questi farmaci potrebbero alterare la progressione della malattia in alcuni partecipanti con PBC].
    10. Avvio o aumento della dose di bezafibrato o fenofibrato in qualsiasi momento nei 3 mesi precedenti lo screening. I partecipanti, al momento dell’ingresso nello studio, devono essere in terapia a dosi stabili con questi farmaci, ma non sono consentite modifiche o interruzioni fino al completamento del periodo di studio principale. [Razionale: evidenze limitate indicano che i fibrati potrebbero migliorare ALP e prurito].
    11. Avvio o aumento della dose di uno dei seguenti agenti nelle 8 settimane prima dello screening: rifampicina, naltrexone, naloxone, nalfurafina o sertralina. I partecipanti, al momento dell’ingresso nello studio, devono essere in terapia a dosi stabili o ridotte con questi farmaci, ma non sono consentite modifiche fino al completamento del periodo di studio principale.
    12. Utilizzo di resine leganti gli acidi biliari: i partecipanti dovranno interrompere l’uso di colestiramina, colesevelam, colestipolo o colestimide prima dell’inizio del periodo di studio iniziale (al più tardi il Giorno -2). NB: questi farmaci possono essere somministrati dopo il completamento del periodo di studio principale, in presenza di indicazione clinica.
    13. Utilizzo di acido obeticolico: i partecipanti dovranno interrompere l’uso di acido obeticolico almeno 8 settimane prima del periodo di studio iniziale e non potranno riprendere tale terapia fino alla conclusione dello studio.
    14. Somministrazione di un qualunque altro inibitore del trasporto ileale degli acidi biliari (Ileal Bile Acid Transport, IBAT) nei 3 mesi precedenti lo screening [Razionale: è possibile che gli effetti di un altro inibitore di IBAT influenzino il prurito]
    15. Attuale arruolamento o partecipazione nelle 8 settimane precedenti l’inizio del periodo di studio iniziale a qualsiasi altro studio clinico su un trattamento sperimentale.
    16. QTc > 480 msec Nota: QTc è l'intervallo QT corretto per la frequenza cardiaca secondo la formula di Bazett (QTcB), di Fridericia (QTcF) o altro metodo; viene calcolato dalla macchina o manualmente. La formula specifica utilizzata per determinare l'idoneità o la sospensione per un singolo partecipante deve essere determinata prima di iniziare lo studio. In altre parole, non si possono utilizzare più formule per calcolare il QTc di un partecipante e adottare il valore più basso per inserirlo nello studio o per farlo uscire in anticipo.
    17. Anamnesi positiva per sensibilità al trattamento in studio o ai suoi componenti, o anamnesi positiva per allergia a farmaci o allergia di altro tipo che, secondo il giudizio dello sperimentatore o del responsabile del monitoraggio clinico di GSK, rappresenta una controindicazione alla partecipazione allo studio.
    18. Consumo regolare di alcool nei 6 mesi precedenti lo studio, definito da un’assunzione settimanale media di > 21 unità per gli uomini o > 14 unità per le donne. Una unità è equivalente a 8 g di alcol: mezza pinta (circa 240 ml) di birra, 1 bicchiere (125 ml) di vino, una dose (25 ml) di liquore.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from Baseline at Week 16 in the Mean Worst Daily Itch
    Score.
    Variazione media dal basale alla Settimana 16 del punteggio medio relativo al peggiore dolore quotidiano
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    settimana 16
    E.5.2Secondary end point(s)
    ¿ Mean change from Baseline at Week 16 in PBC-40 Scale.
    In participants meeting the criteria for high risk of PBC progression:
    ¿ Mean change from Baseline at Week 16 in serum ALP concentrations.
    ¿ Proportion of participants having serum ALP concentrations <1.67x
    ULN and total bilirubin concentrations =ULN at Week 16.
    ¿ Mean change from Baseline at Week 16 in serum ALT, AST, GGT, total
    bilirubin and albumin concentrations and PT/INR.
    Variazione media dal basale alla Settimana 16 della scala PBC-40.
    Nei partecipanti che soddisfano i criteri di alto rischio di progressione della PBC:
    ¿ Variazione media dal basale alla Settimana 16 delle concentrazioni sieriche di ALP.
    ¿ Percentuale di partecipanti con concentrazioni sieriche di ALP <1,67 x ULN e concentrazioni della bilirubina totale ¿ULN alla Settimana 16 .
    ¿ Variazione media dal basale alla Settimana 16 delle concentrazioni sieriche di alanina aminotransferasi (ALT), aspartato aminotransferasi (AST), gamma-glutamiltransferasi (GGT), bilirubina totale e albumina, e del rapporto tempo di protrombina/rapporto internazionale normalizzato (PT/INR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16
    settimana 16
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 trial5
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Australia
    Canada
    France
    Japan
    Netherlands
    Spain
    United Kingdom
    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
    LVLS
    ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 150
    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)
    The Sponsor will not provide treatment after the end of the study; participants should be managed according to their treating physician.
    Lo sponsor non fornir¿ il trattamento dopo la conclusione dello studio; i partecipanti dovranno essere trattati secondo quanto stabilito dal loro medico curante
    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 Decision2017-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
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