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    Summary
    EudraCT Number:2019-003158-10
    Sponsor's Protocol Code Number:212358
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003158-10
    A.3Full title of the trial
    Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis
    Studio di sicurezza e tollerabilità a lungo termine di linerixibat nel trattamento del prurito colestatico in partecipanti con colangite biliare primitiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Linerixibat Long-term Safety and Tolerability Study
    Studio di sicurezza e tollerabilità a lungo termine di linerixibat (LLSAT)
    A.3.2Name or abbreviated title of the trial where available
    Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC
    Studio di sicurezza e tollerabilità a lungo termine di linerixibat nel trattamento del prurito coles
    A.4.1Sponsor's protocol code number212358
    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 supportGlaxoSmithKline LLC
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+448007839733
    B.5.5Fax number00000000
    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 nameLinerixibat (GSK2330672) 45mg
    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 INNLinerixibat
    D.3.9.1CAS number 1345982-69-5
    D.3.9.2Current sponsor codeGSK2330672
    D.3.9.4EV Substance CodeSUB194569
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
    Prurito da moderato a severo causato da colangite biliare primitiva (CBP)
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
    Prurito da moderato a severo causato da colangite biliare primitiva (CBP)
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10064190
    E.1.2Term Cholestatic pruritus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064190
    E.1.2Term Cholestatic pruritus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 safety and tolerability of long-term linerixibat treatment in participants with cholestatic pruritus in PBC
    Valutare la sicurezza e la tollerabilità a lungo termine del trattamento con linerixibat in partecipanti con prurito colestatico associato a CBP
    E.2.2Secondary objectives of the trial
    -To characterize the effects of long-term linerixibat treatment on disease burden and health related QOL in participants with cholestatic pruritus in PBC
    -To characterize the effects of long-term linerixibat treatment in PBC population
    - Caratterizzare gli effetti del trattamento a lungo termine con linerixibat sul carico di malattia e la qualità di vita (QoL) correlata alla salute in partecipanti con prurito colestatico associato a CBP
    - Caratterizzare gli effetti del trattamento a lungo termine con linerixibat nella popolazione CBP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all the following criteria apply:
    Age
    1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant’s parent trial BAT117213 or 201000
    Type of Participant and Disease Characteristics
    2. Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial(BAT117213 or 201000)
    3. Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213 or 201000)
    Sex
    4. Male or female
    Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraception by male participants or male partners of female participants is not required in this protocol
    a. Female Participants:
    -A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    o Is not a woman of childbearing potential (WOCBP)
    OR
    o Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, as described in [Appendix 4] of Protocol, during the intervention period and for at least 4 weeks, after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention
    o A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention
    o If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    -Additional requirements for pregnancy testing during and after study intervention are listed in [Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information] of Protocol
    -The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
    -Informed Consent
    5. Capable of giving signed informed consent as described in [Appendix 1] of protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    I partecipanti sono considerati eleggibili ai fini dell’inclusione nello studio solo se soddisfano tutti i criteri indicati di seguito:
    Età
    1. Il partecipante deve avere un’età compresa tra i 18 e gli 80 anni inclusi al momento della firma del consenso informato nella sperimentazione precedente (BAT117213 o 201000)
    Tipo di partecipante e caratteristiche della malattia
    2. Partecipanti con una diagnosi di CBP e una storia di prurito associato, attestata dalla randomizzazione in una precedente sperimentazione clinica su linerixibat (BAT117213 o 201000)
    3. I partecipanti devono aver completato il periodo di trattamento principale in una precedente sperimentazione clinica su linerixibat idonea (BAT117213 o 201000)
    Sesso
    4. Entrambi i sessi
    L’uso dei contraccettivi da parte delle pazienti di sesso femminile deve essere coerente con i regolamenti locali riguardanti i metodi contraccettivi per chi partecipa a studi clinici. L’uso di misure contraccettive da parte dei partecipanti di sesso maschile o dei partner maschili delle partecipanti di sesso femminile non è richiesto da questo protocollo
    Partecipanti di sesso femminile:
    Sono eleggibili alla partecipazione se non sono in gravidanza o in allattamento e se almeno una delle condizioni indicate di seguito risulta applicabile:
    o Non si tratta di una donna in età fertile
    OPPURE
    o Si tratta di una donna in età fertile che utilizza un metodo contraccettivo altamente efficace (caratterizzato da un tasso di fallimento < 1% l’anno), con bassa dipendenza dall’utilizzatore, come illustrato in [Appendice 4 del protocollo] durante il periodo di intervento dello studio e per almeno 4 settimane dopo l’ultima dose dell’intervento in studio. Lo sperimentatore deve valutare l’efficacia del metodo contraccettivo in relazione alla prima dose del farmaco sperimentale.
    o Una donna in età fertile deve presentare un risultato negativo a un test di gravidanza ad alta sensibilità (condotto sul siero o sulle urine secondo quanto richiesto dalle normative locali) nelle 24 ore precedenti la prima dose dell’intervento in studio.
    o Se un test delle urine non può essere confermato come negativo (per es. risultato ambiguo), si richiede un test di gravidanza sul siero. In questi casi la partecipante deve essere esclusa se il test di gravidanza sul siero risulta positivo.
    Ulteriori requisiti per i test di gravidanza durante e dopo l’intervento in studio sono elencati in [Appendice 4 del protocollo: Guida alla contraccezione e alla raccolta di informazioni sulla gravidanza]
    Lo sperimentatore è responsabile della raccolta di anamnesi, anamnesi mestruale e attività sessuale recente per ridurre il rischio di inclusione di donne in gravidanza in fase iniziale non rilevata.
    Consenso informato
    5. Soggetti in grado di fornire e firmare il proprio consenso informato, come descritto in [Appendice 1 del protocollo] che presuppone la conformità ai requisiti e alle limitazioni enumerati nel modulo di consenso informato (CI) e nel presente 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. Total 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. Recent or current clinically significant diarrhea in the Investigator’s medical opinion
    7. Current symptomatic cholelithiasis or inflammatory gallbladder disease is exclusionary. Participants with history of cholecystectomy =3 months before screening may be eligible for enrollment
    8. Current diagnosis or previous diagnosis of colorectal cancer
    9. 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
    10. Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and may not restart until after the end of the study or study withdrawal. [Rationale: The potential for a Drug-Drug Interaction (DDI) between obeticholic acid and linerixibat has not been determined. A DDI study assessing the concomitant use of OCA and linerixibat is planned and depending on those results this OCA exclusion may be removed]
    11. Administration of any other IBAT inhibitor in the 1 month prior to screening
    [Rationale: Effects of another IBAT inhibitor may confound interpretation of the linerixibat safety and tolerability profile]
    Prior/Concurrent Clinical Study Experience
    12. Current enrollment or participation in any other clinical study (except for 201000)
    involving an investigational study treatment within 8 weeks prior to the screening visit
    Note: For participants coming from the 201000 study there is no specified waiting period before enrollment into this safety study.
    Diagnostic assessments
    13. QTc >480 msec
    NOTES: The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Frederica’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 and maintained for individual participants throughout study participation. The specific QT correction formula used must be specified in the eCRF
    A QTc >480 msec (12-lead ECG) at screening is exclusionary
    Note: The QT interval will be assessed at screening and at each long visit (yearly) by 12-Lead ECG. QTc stopping criteria are established for this study and are detailed in [Section 7.1.2] of Protocol
    Other Exclusions
    14. 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
    Saranno esclusi dallo studio i sogg che rispond a uno qualsiasi dei seguenti criteri:
    Condiz clin
    1. Bilirubina tot allo screening > 2 volte l’ULN. È accettab un livello di bilirubina totale>2 x ULN a condiz che la bilirubina sia frazion e che la bilirubina diretta sia<35%.
    2. ALT o aspartato aminotransferasi (AST) allo screening > 6 volte ULN.
    3. Velocità di filtraz glom stimata (eGFR) allo screening<45 ml/min/1,73m2 in base all’equaz CKD-EPI(Chronic Kidney Disease Epidemiology Collaboration).
    4. Storia o pres di scompenso epat(es. sanguinam da varici,encefalopatia o ascite)
    5. Pres di infez da virus dell’epat B o C(HBV, HCV) attiv replicante e/o carcinoma epatocell o cancro biliare conferm
    NB: altre condiz epatiche(per es.colang sclerosante prim[Primary Sclerosing Cholangitis, PSC],epatopatia alcolica, epatite autoimm,steatoepatite non alcolica [NonAlcoholic SteatoHepatitis,NASH]) sono ammesse qual la CBP sia il danno epat dominan a giudizio dello sperim.
    6. Diarrea rec o clinicam rilevante secondo il parere medico dello sperim
    7. La pres di colelitiasi sintom o malattia infiamm della colelitiasi è motivo di esclus.I partecip con colecistectom eseguita=3 mesi prima dello screen poss essere elegg per l’arruolam.
    8. Diagnosi attuale o diagnosi preced di cancro colonrett.
    9. Qualsiasi condiz clinica attuale (ad es. disturbo psichiatrico, senilità o demenza) che potrebbe pregiudicare la capacità del partecipante di rispettare le procedure previste dal protocollo
    Terapie precedenti/concomitanti
    10. Impiego di acido obeticolico (OCA): nelle 8 settimane precedenti la data della visita di screening e fino a dopo la conclusione dello studio o il ritiro dallo studio. [Razionale: la possibilità di interazione farmaco-farmaco tra acido obeticolico e linerixibat non è stata stabilita. È in programma uno studio di interazione farmaco-farmaco per valutare l’uso concomitante di OCA e linerixibat e in funzione dei risultati questa esclusione dell’OCA potrebbe essere eliminata]
    11. Somministrazione di un qualunque altro inibitore di IBAT nel mese precedente lo screening [Razionale: gli effetti di un altro inibitore di IBAT potrebbero confondere l’interpretazione del profilo di sicurezza e tollerabilità di linerixibat]
    Esperienza in studi clinici precedenti/concomitanti
    12. Attuale arruolamento o partecipazione a qualsiasi altro studio clinico (eccetto per lo studio 201000) che preveda la somministrazione di un trattamento sperimentale nelle 8 settimane precedenti la visita di screening
    NB: per i partecipanti che provengono dallo studio 201000 non è richiesto un periodo di attesa specifico prima dell’arruolamento in questo studio sulla sicurezza.
    Valutazioni diagnostiche
    13. QTc > 480 msec
    NOTE: il QTc è l’intervallo QT corretto per la frequenza cardiaca in base alla formula di Bazett (QTcB), alla formula di Fridericia (QTcF) e/o ad altri metodi. Viene rilevato mediante strumenti o manualmente
    La formula specifica utilizzata per determinare l’eleggibilità e l’interruzione dello studio per il singolo partecipante dovrà essere stabilita prima dell’inizio dello studio e utilizzata nei singoli partecipanti per l’intera durata della partecipazione allo studio. La specifica formula di correzione del QT utilizzata dovrà essere registrata nella eCRF
    Un valore del QTc > 480 msec (ECG a 12 derivazioni) allo screening costituisce motivo di esclusione
    NB: l’intervallo QT sarà valutato allo screening e in occasione di ogni visita lunga (a cadenza annuale) mediante ECG a 12 derivazioni. Per questo studio sono stati stabiliti dei criteri di interruzione dello studio in base al valore QTc, che sono elencati nella [Sezione 7.1.2 del protocollo].
    Altre esclusioni
    14. Consumo regolare di alcool nei 6 mesi precedenti lo studio, definito da un’assunzione media di > 21 unità per gli uomini o > 14 unità per le donne. Una unità è equivalente a 8 g di alcol: una mezza pinta (circa 240 ml) di birra, 1 bicchiere (125 ml) di vino o 1 misura (25 ml) di liquori
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of adverse events
    Frequenza e gravità degli eventi avversi
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of treatment (Day1) to follow up phone call (Day 7 to 14 post-final dose of IP). Assessments are made on Day 1, Week 1, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42, Month 48 and final follow phone call on Day 7 to Day 14 post final dose of IP.
    Dall'inizio del trattamento (Giorno 1) alla telefonata di follow up (Giorno 7-14 dopo la dose finale dell'IP). Le valutazioni vengono effettuate il giorno 1, la settimana 1, il mese 1, il mese 2, il mese 3, il mese 6, il mese 9, il mese 12, il mese 18, il mese 24, il mese 30, il mese 36, il mese 42, il mese 48 e l'ultima chiamata telefonica successiva dal giorno 7 al giorno 14 dopo la dose finale di IP.
    E.5.2Secondary end point(s)
    1.Change in domain scores of the PBC-40 over time
    2.Change in health-related QoL by the EQ-5D-3L summary index number (utility) over time
    3.Change in the EQ VAS (within the EQ-5D-3L) over time
    4.Change in the BDI-II over time
    5.Trends in clinically meaningful laboratory values including liver parameters and lipids over time
    • Variazione dei punteggi dei domini del questionario PBC-40 nel corso del tempo
    • Variazioni della QoL correlata alla salute sulla base del punteggio dell’indice sintetico dell’EQ-5D-3L (utilità) nel corso del tempo
    Variazione della scala EQ VAS (all’interno di EQ-5D-3L) nel corso del tempo
    • Variazione del BDI-II nel corso del tempo
    • Tendenze dei valori di laboratorio clinicamente rilevanti, compresi i parametri di funzionalità epatica e i lipidi nel corso del tempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    For secondary endpoints numbers 1-4 the timepoints of evaluation are:
    From start of treatment (Day 1) until the final study visit (approximately Month 48). Assessments are made on Day 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24,Month 30, Month 36, Month 42 and Month 48.
    For secondary endpoint number 5 the timepoints of evaluation are:
    From start of treatment (Day 1) until the final study visit (approximately Month 48). Assessments are made on Day 1, Month 3, Month 6, Month 9, Month 12, Month 24, Month 36 and Month 48.
    Per gli endpoint secondari da 1 a 4, i timepoints della valutazione sono:
    Dall'inizio del trattamento (giorno 1) fino alla visita di fine studio (circa mese 48). Le valutazioni vengono effettuate il giorno 1, il mese 3, il mese 6, il mese 9, il mese 12, il mese 18, il mese 24, il mese 30, il mese 36, il mese 42 e il mese 48.
    Per l'endpoint secondario numero 5, i timepoints della valutazione sono:
    Dall'inizio del trattamento (giorno 1) fino alla visita di fine studio (circa mese 48). Le valutazioni vengono effettuate il giorno 1, il mese 3, il mese 6, il mese 9, il mese 12, il mese 24, il mese 36 e il mese 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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    IN APERTO
    OPEN
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Canada
    Japan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero 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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 75
    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
    Nessuno
    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 Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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