Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-000574-11
    Sponsor's Protocol Code Number:SHP647-304
    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:2021-01-20
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-000574-11
    A.3Full title of the trial
    A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
    Studio di estensione di fase 3, per valutare la sicurezza a lungo termine di SHP647 in soggetti con colite ulcerosa o malattia di Crohn da moderata a grave (AIDA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)
    Studio di ricerca per determinare se il prodotto medicinale sperimentale, SHP647, è sicuro ed efficace a lungo termine nel trattamento della colite ulcerosa o malattia di Crohn da moderata a grave (AIDA)
    A.3.2Name or abbreviated title of the trial where available
    AIDA
    AIDA
    A.4.1Sponsor's protocol code numberSHP647-304
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03283085
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:NANumber:NA
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/281/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSHIRE HUMAN GENETIC THERAPIES, 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 supportShire Human Genetic Therapies, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Human Genetic Therapies, Inc.
    B.5.2Functional name of contact pointChantal L. Letourneau
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number0017814820852
    B.5.5Fax number0017814822954
    B.5.6E-mailchantal.letourneau@shire.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.2.1.1.1Trade name -
    D.2.1.1.2Name of the Marketing Authorisation holder-
    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 nameSHP647
    D.3.2Product code [SHP647]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNontamalimab
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.2.1.1.1Trade name -
    D.2.1.1.2Name of the Marketing Authorisation holder-
    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 nameSHP647
    D.3.2Product code [SHP647]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNontamalimab
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Ulcerative colitis or Crohn's Disease
    Colite Ulcerosa o malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Long-term condition that results in inflammation and ulcers of the colon and rectum or long-term condition that results in inflammation of the the gastrointestinal tract.
    Condizione a lungo termine che comporta infiammazione e ulcere del colon e del retto o condizione a lungo termine che comporta infiammazione dei tratto gastrointestinale.
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the safety and tolerability of long-term treatment with SHP647 in subjects with moderate to severe UC or CD.
    Valutare la sicurezza e la tollerabilità a lungo termine del trattamento con SHP647 in soggetti con colite ulcerosa o malattia di Crohn da moderata a grave.
    E.2.2Secondary objectives of the trial
    ¿ To evaluate the effect of long-term SHP647 treatment on clinical outcomes.
    ¿ To evaluate the effect of long-term SHP647 treatment on abdominal pain, urgency, diarrhea, and absolute stool frequency and bleeding scores.
    ¿ To evaluate the effect of long-term SHP647 treatment on health- related quality of life (HRQL).
    ¿ To evaluate the impact of long-term SHP647 treatment on incidence of hospitalizations and total inpatient days.
    ¿ To evaluate the effect of long-term SHP647 treatment on HRQL using EQ-5D and work productivity.
    ¿ To evaluate the impact of long-term SHP647 treatment on patient satisfaction with medication.
    ¿ To evaluate the impact of long-term SHP647 treatment on incidence of emergency department (ED) visits.
    ¿ To evaluate the impact of long-term SHP647 treatment on incidence of UC-related and other surgeries.
    ¿ To evaluate SHP647 pharmacokinetics during long-term treatment.
    ¿ To evaluate the impact of long-term SHP647 treatment on selected biomarkers.
    Valutazione a lungo termine di:
    ¿ effetto trattamento con SHP647 sugli esiti clinici.
    ¿ effetto trattamento con SHP647 in base ai punteggi di dolore addominale, urgenza intestinale, diarrea, frequenza defecatoria assoluta e sanguinamento.
    ¿ effetto trattamento con SHP647 sulla qualit¿ della vita correlata allo stato di salute (HRQL).
    ¿ impatto trattamento con SHP647 sull¿incidenza dei ricoveri ospedalieri e giorni totali di ricovero.
    ¿ effetto trattamento con SHP647 su HRQL utilizzando EQ-5D e produttivit¿ lavorativa.
    ¿ impatto del trattamento con SHP647 sulla soddisfazione del paziente in relazione al farmaco.
    ¿ impatto trattamento con SHP647 sull¿incidenza delle visite al Pronto Soccorso (ED).
    ¿ impatto trattamento con SHP647 su incidenza di interventi chirurgici correlati alla CU e altri interventi
    ¿ farmacocinetica di SHP647 durante il trattamento
    ¿ impatto del trattamento con SHP647 su determinati biomarcatori.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Refer to the protocol
    Riferirsi al protocollo
    E.4Principal exclusion criteria
    refer to the protocol
    riferirsi al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is safety assessment as is assessment of safety as measured by: incidence and severity of AEs; incidence and nature of serious infections; actual values and change from baseline, as well as the incidence of abnormalities, in laboratory tests, ECGs, and vital signs; and antidrug antibodies.
    L’endpoint primario è la valutazione della sicurezza misurata in base a: incidenza e gravità degli AE; incidenza e natura delle infezioni serie; valori attuali e variazioni rispetto al baseline, incidenza delle anomalie nei test di laboratorio, negli ECG e nelle funzioni vitali; nonché anticorpi anti-farmaco.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to section "Study Schedules" of the Protocol
    Fare riferimento alla sezione “Programmi dello studio” del protocollo
    E.5.2Secondary end point(s)
    The exploratory efficacy endpoints are as follows: Subjects with Ulcerative Colitis
    • Proportion of subjects in remission based on composite score, assessed yearly and at end of study. Remission is defined as a composite score of patient-reported symptoms using daily diary and locally read endoscopy as follows: stool frequency subscore of 0 or 1 with at least a 1-point change from induction study (SHP647-301 or SHP647-302) baseline AND rectal bleeding subscore of 0 AND locally-read endoscopic subscore of 0 or 1 (modified, excludes friability).
    • Proportion of subjects with remission, based on total Mayo score, assessed yearly and at end of study. Remission is defined as a total Mayo score = 2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1.
    • Proportion of subjects with clinical remission as defined by as defined by stool frequency subscore of 0 or 1 with at least a 1-point change from induction study (SHP647-301 or SHP647-302) baseline in stool frequency subscore, and rectal bleeding subscore of 0, assessed yearly and at end of study.
    • Proportion of subjects having partial Mayo score of =2 with no individual subscore >1 over time. The partial Mayo score does not include the endoscopy subscore.
    • Endoscopic remission, as defined by locally read endoscopic subscore 0 or 1 (modified, excludes friability), assessed yearly and at end of study.; Subjects with Crohn's Disease
    • Clinical remission over time. Clinical remission is defined by 2-item PRO CD daily e-diary subscore of average worst daily abdominal pain =3 (based on 11-point NRS over the 7 most recent days) and average daily stool frequency =2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days.
    • Enhanced endoscopic response, assessed yearly and at end of study, as measured by a decrease in SES-CD of at least 50% from induction study (SHP647-305 or SHP647-306) baseline.
    • Clinical remission over time as measured by CDAI <150.
    • Clinical remission over time as defined by the following: CD daily ediary subscores of average worst daily abdominal pain =1 (based on the 4-point scale) over the 7 most recent days and average daily stool frequency =3 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days.
    Both clinical remission by 2-item PRO and enhanced endoscopic response over time (composite endpoint).
    •Complete endoscopic healing at end of study, defined as SES-CD=0-2.
    All efficacy analyses will be performed using the full-analysis set. Secondary efficacy endpoints will be summarized by treatment group using descriptive statistics at each assessment visit. Summaries may be presented by the status at entry into the study (eg, induction nonresponder, maintenance SHP647 completer, etc). Statistical summaries will include number of subjects and percentages, and 95% confidence intervals.
    Gli endpoint di efficacia esplorativi sono i seguenti: Soggetti con colite ulcerosa:
    • remissione in base al punteggio composito,valutato annualmente e alla fine dello studio. La remissione è definita come un punteggio composito dei sintomi riferiti dal paziente mediante la compilazione giornaliera del diario e della lettura endoscopica locale come segue: sottopunteggio di frequenza defecatoria di 0 o 1 con variazione di almeno 1 punto rispetto alla baseline dello studio di induzione (SHP647-301 o SHP647-302) E sottopunteggio per il sanguinamento rettale di 0 E sottopunteggio endoscopico letto a livello locale di 0 o 1 (modificato, esclude la friabilità).
    • remissione in base al punteggio Mayo totale, valutato annualmente e alla fine dello studio. La remissione è definita come punteggio Mayo totale =2 e nessun sottopunteggio individuale (frequenza defecatoria, sanguinamento rettale, endoscopia [modificato, esclude la friabilità] e valutazione globale del medico) superiore a 1 punto.
    • remissione clinica, definita da un sottopunteggio di frequenza defecatoria di 0 o 1 con variazione di almeno 1 punto rispetto alla baseline dello studio di induzione (SHP647-301 o SHP647-302) nel sottopunteggio di frequenza defecatoria e di sanguinamento rettale di 0, valutata annualmente e alla fine dello studio. Percentuale di soggetti con punteggio Mayo parziale =2 e nessun sottopunteggio individuale >1 nel tempo. Il punteggio Mayo parziale non include il sottopunteggio endoscopico.
    • risposta clinica sulla base del punteggio composito, valutata annualmente e alla fine dello studio. La risposta clinica è definita come diminuzione rispetto alla baseline dello studio di induzione (SHP647-301 o SHP647-302) del punteggio composito dei sintomi riferiti dal paziente mediante la compilazione giornaliera del diario e la lettura endoscopica locale di almeno 2 punti e almeno il 30%, con una diminuzione associata del sottopunteggio per il sanguinamento rettale =1 punto o un sottopunteggio per il sanguinamento rettale =1.; Remissione endoscopica, definita da un sottopunteggio di 0 o 1 (modificato, esclude la friabilità) della lettura a livello locale dell’endoscopia, valutata annualmente e alla fine dello studio.
    Soggetti con malattia di Crohn:
    • Remissione clinica nel tempo. La remissione clinica è definita dal sottopunteggio del diario elettronico giornaliero PRO-CD a 2 voci della media del dolore addominale peggiore quotidiano =3 (sulla base della NRS a 11 punti ) negli ultimi 7 giorni e media della frequenza defecatoria quotidiana =2 di tipo 6/7 (feci liquide/molto morbide) come mostrato nella BSFS negli ultimi 7 giorni.
    • Migliore risposta endoscopica valutata annualmente e alla fine dello studio misurata da una diminuzione nel SES-CD di almeno il 50% rispetto alla baseline dello studio di induzione (SHP647-305 o SHP647-306).
    • Remissione clinica nel corso del tempo misurata da CDAI <150
    • Remissione clinica nel corso del tempo definita in base a quanto segue: sottopunteggi riportati quotidianamente sul diario elettronico relativo alla CD relativi alla media del dolore addominale peggiore quotidiano =1 (sulla base della scala a 4 punti ) negli ultimi 7 giorni e media della frequenza defecatoria quotidiana =3 di tipo 6/7 (feci liquide/molto morbide) come mostrato nella BSFS negli ultimi 7 giorni.
    • Remissione clinica in base al PRO a 2 voci e risposta endoscopica migliore nel tempo (endpoint composito)
    • Guarigione endoscopica completa alla fine dello studio definita da SES-CD=0-2.
    Tutte le analisi di efficacia saranno effettuate sul gruppo di analisi completo.
    Gli endpoint di efficacia secondari saranno sintetizzati in base al gruppo di trattamento utilizzando statistiche descrittive in occasione di ciascuna visita di valutazione. Le sintesi possono essere presentate in base allo stato all’ingresso nello studio (per esempio non-responder nello studio di induzione, soggetto completato nello studio di mantenimento con SHP647, ecc). Le sintesi dei dati statistici includeranno il numero e le percentuali di soggetti e intervalli di confidenza al 95%.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 24 weeks, yearly, at end of study, or a combination, as detailed in E.5.1; Every 24 weeks, yearly, at end of study, or a combination, as detailed in E.5.1
    Ogni 24 settimane, annualmente, alla fine dello studio o una combinazione, come descritto in modo dettagliato nella sezione E.5.1; Ogni 24 settimane, annualmente, alla fine dello studio o una combinazione, come descritto in modo dettagliato nella sezione E.5.1
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Qualità della vita
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    25 mg o 75 mg di SHP647
    25 mg or 75 mg SHP647
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA167
    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
    Argentina
    Australia
    Bosnia and Herzegovina
    Brazil
    Canada
    Colombia
    Israel
    Japan
    Mexico
    New Zealand
    Russian Federation
    South Africa
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Czechia
    Estonia
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Lithuania
    Netherlands
    Poland
    Portugal
    Romania
    Slovakia
    Spain
    Switzerland
    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
    The Study Completion Date is defined as the date the final subject, across all sites, completes their final protocol-defined assessment. Please note that this includes the follow-up visit or contact, whichever is later.
    La data di completamento dello studio è definita come la data in cui l'ultimo soggetto, in tutti i centri, completa la valutazione finale definita dal protocollo. Si noti che ciò include la visita o il contatto di follow-up, a seconda di quale evento si verifica più tardi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months11
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 247
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents (16-17 years)
    Adolescenti (16-17 anni)
    F.4 Planned number of subjects to be included
    F.4.1In the member state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 967
    F.4.2.2In the whole clinical trial 2453
    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)
    At the end of this study patients will return to standard of care.
    Alla fine di questo studio i pazienti torneranno a ricevere lo standard di cura.
    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 Decision2018-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-21
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 05 18:41:25 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA