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    Summary
    EudraCT Number:2011-001847-58
    Sponsor's Protocol Code Number:ARD12042
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-29
    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 number2011-001847-58
    A.3Full title of the trial
    A Randomized Phase II, Open-Label study of the Efficacy and Safety of Orally Administered SAR302503 in patients with polycythemia vera (PV) or essential thrombocythemia (ET) who are resistant or intolerant to hydroxyurea
    A Randomized Phase II, Open-Label study of the Efficacy and Safety of Orally Administered SAR302503 in patients with polycythemia vera (PV) or essential thrombocythemia (ET) who are resistant or intolerant to hydroxyurea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with SAR302503 in polycythemia vera or essential thrombocythemia
    Studio con SAR302503 in pazienti con policitemia vera o trombocitopenia essenziale
    A.4.1Sponsor's protocol code numberARD12042
    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 SponsorSANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportsanofi-aventis recherche & de'veloppement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-aventis SpA
    B.5.2Functional name of contact pointContact point
    B.5.3 Address:
    B.5.3.1Street AddressVle Bodio 57/b
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800.226343
    B.5.5Fax number02.3939.4168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi-aventis.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/810 and EU/3/10/811
    D.3 Description of the IMP
    D.3.2Product code SAR302503
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeSAR302503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    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/3/10/810 and EU/3/10/811
    D.3 Description of the IMP
    D.3.2Product code SAR302503
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeSAR302503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    polycythemia vera, or essential thrombocythemia
    Policitemia o trombocitopenia essenziale
    E.1.1.1Medical condition in easily understood language
    blood disorder in which the bone marrow makes too many red blood cells, or blood disorder in which the bone marrow makes too many platelets
    malattia del sangue in cui il midollo osseo produce troppi globuli rossi, o malattia del sangue in cui il midollo osseo produce troppe piastrine
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10018865
    E.1.2Term Haematopoietic neoplasms (excl leukaemias and lymphomas)
    E.1.2System Organ Class 10005329 - Blood and lymphatic system 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 efficacy of daily oral doses of 100, 200 and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with PV, and Reduction of platelet count to ≤400 x 10 exp9/L for a minimum of 3 months in patients with ET.
    Dimostrare l’efficacia di SAR302503 somministrato ogni giorno per via orale alle dosi di 100, 200 e 400 mg in pz ffetti da policitemia vera (PV) e da trombocitemia essenziale (TE) che sono resistenti o intolleranti a idrossiurea (in accordo ai criteri europei LeukemiaNet):
    •nell’eliminazione della necessità di flebotomie e nell’induzione di un ematocrito &lt;al 45% per 3 mesi in pz con policitemia vera;
    •nella riduzione della conta piastrinica fino a ≤ 400 x 109/L per un minimo di 3 mesi in pz con trombocitemia essenziale.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of SAR302503. To evaluate the efficacy of daily oral doses of 100, 200 and 400 mg SAR302503 in inducing complete and partial responses (complete response and partial response) per European LeukemiaNet consensus criteria. To evaluate the pharmacokinetics of SAR302503 after single and repeat doses. To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in those patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition. To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life, through serial administration of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF). To measure generic health-related quality of life and utility values using the EuroQol Group (EQ-5D™) questionnaire
    •Valutare il profilo di tollerabilità di SAR302503.
    •Dimostrare l’efficacia di SAR302503 somministrato ogni giorno per os alle dosi di 100, 200 e 400 mg nell’indurre risposte complete e parziali, in accordo ai criteri del “consensus-europeo” LeukemiaNet.
    •Valutare la farmacocinetica di SAR302503 dopo somministrazione di dosi singole e ripetute.
    •Valutare la farmacodinamica di SAR302503 in base alle variazioni del carico mutazionale di JAK2V617F, nei pazienti con mutazione di JAK2V617F, e all’inibizione della fosforilazione STAT3.
    •Misurare il miglioramento dei sintomi associati ai disordini mieloproliferativi del basale, e l’impatto sulla QdV, somministrando al paziente nel corso dello studio il questionario “Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)”.
    .Misurare i param. generici di QdV correlati alla salute e e i param,
    di utilità, con EuroQol Group EQ-5D™)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of hydroxyurea resistant or intolerant PV or ET. PV or ET defined according to the revised WHO criteria (6) PV resistance or intolerance to hydroxyurea is defined as PV patients on hydroxyurea with a hematocrit >45%, or phlebotomy twice in the last 6 months and at least once in the last 3 months (1). ET resistance or intolerance to hydroxyurea is defined as ET patients on hydroxyurea with platelet count >600 x 10 exp9/L (2). Provide written informed consent to participate.
    I 01. Pazienti con diagnosi di policitemia vera o di trombocitemia essenziale resistenti o intolleranti a idrossiurea.
    • La diagnosi di policitemia vera o di trombocitemia essenziale deve essere fatta in accordo ai criteri aggiornati WHO.
    - La policitemia vera resistente o intollerante a idrossiurea è definita come policitemia vera in pazienti in trattamento con idrossiurea con un ematocrito &gt; 45% o che sono stati sottoposti a 2 flebotomie negli ultimi 6 mesi, con almeno una eseguita negli ultimi 3 mesi.
    - La trombocitemia essenziale resistente o intollerante a idrossiurea è definita come trombocitemia essenziale in pazienti in trattamento con idrossiurea con una conta delle piastrine&gt; 600 x 109/L.
    I 02. Consenso informato scritto a partecipare allo studio
    E.4Principal exclusion criteria
    Less than 18 years of age. Participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to initiation of study drug, unless during non-treatment phase. (Prior treatment with another JAK2 inhibitor is allowed.) Unwilling to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures. Eastern Cooperative Oncology Group performance status of 3 or 4 at study entry. Splenectomy. Contraindications for undergoing magnetic resonance imaging in patients with palpable spleens (eg, metal implants). Any chemotherapy (eg, hydroxyurea), radiophosphorus therapy, immunomodulatory drug therapy (eg, interferon-alpha), corticosteroids >10 mg/day prednisone or equivalent or anagrelide within 14 days prior to initiation of study drug Active malignancy other than PV or ET, except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies that have been stable and off therapy for ≥5 years. Major surgery within 28 days or radiation within 3 months prior to initiation of study drug. Unable to swallow capsules. Active acute infection requiring antibiotics. Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness. Clinically active hepatitis B or C. Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug. Any severe acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with interpretation of study results and, in the Investigator’s opinion, would make the patient inappropriate for entry into this study. The following laboratory values within 14 days prior to initiation of study drug: Absolute neutrophil count (ANC) <1.5 x10 exp9/L Platelet count <50 x 10 exp9/L Serum creatinine >1.5 x the upper limit of normal (ULN) Serum amylase or lipase >1.5 x ULN Total bilirubin >1.5 x ULN Aspartate aminotransferase or alanine aminotransferase >3 x ULN (higher values [≤5 x ULN] are allowed if clinically compatible with hepatic extramedullary hematopoiesis). Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers CYP3A4, unless approved by the Sponsor. Presence of any gastric or other disorder that would inhibit absorption of oral medication. Known hypersensitivity to any excipients in the study drug formulation Pregnant or lactating female. Women of childbearing potential, unless using effective contraception while on study drug. Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug
    01.Età inferiore ai 18 anni.
    02.Partecipazione in altri studi clinici con trattamenti sperimentali (farmaci, biologici o device) nei 30 gg precedenti l’inizio del trattamento in studio, ad eccezione della fase di non-trattamento. Sono permessi trattamenti precedenti con altri inibitori di JAK2.
    03.Pz non disposti a rispettare le visite programmate, i piani di trattamento, le valutazioni di laboratorio, e le altre procedure correlate allo studio.
    04. ECOG, performance status pari a 3 o 4 all’ingresso nello studio.
    05.Pz sottoposti a splenectomia.
    06.Controindicazioni ad essere sottoposti a RM (ad es. per presenza di impianti metallici) in pz. con milza palpabile.
    07.Pz sottoposti a terapia entro 14 gg prima dell’inizio del trattamento in studio con qualsiasi chemioterapico (ad esempio, idrossiurea), con terapia con radiofosforo, con qualsiasi terapia farmacologica immunomodulatoria (ad es interferone alfa), o con corticosteroidi (prednisone o equivalente o anagrelide) assunti ad un dosaggio superiore a 10 mg al giorno.
    08.Presenza di altre malignità diverse da policitemia vera o trombocitemia essenziale, ad eccezione di neoplasie cutanee diverse dal melanoma adeguatamente trattato e dal carcinoma in situ della cervice, o di altre patologie tumorali, che siano state stabili e non trattate per un periodo &gt;= a 5 anni.
    9.Pazienti sottoposti a intervento chirurgico importante o a radioterapia rispettivamente nei 28 gg o nei 3 mesi prima dell’inizio del trattamento in studio .
    10.Pz non in grado di deglutire capsule.
    11.Pz con infezioni acute in atto che richiedono terapia antibiotica.
    12.Sindrome nota da immunodeficienza umana virale o acquisita.
    13.Epatite B o C clinicamente in atto.
    14.Pz con insufficienza cardiaca congestizia non controllata (Classificazione 3 o 4 NYHA), angina, IM, eventi cerebrovascolari, bypass aorto-coronarico, attacco ischemico transitorio o embolia polmonare nei 3 mesi prima dell’inizio del trattamento in studio.
    15.Qualsiasi condizione clinica grave, acuta o cronica, o qualsiasi condizione psichiatrica o neurologica, o alterazioni dei valori di laboratorio che secondo l’opinione dello sperimentatore, possano aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del farmaco in studio, o che possa interferire con le procedure relative all’ottenimento del consenso informato e/o con il rispetto dei requisiti dello studio, o che possa interferire con l’interpretazione dei risultati dello studio e che renderebbe il paziente inadeguato per l’arruolamento in questo studio secondo il parere dello sperimentatore.
    16.funzione d'organo inadeguate • .
    17.Trattamento concomitante con farmaci o principi di erboristeria noti per essere inibitori moderati o induttori del citocromo CYP3A4, salvo 18. Presenza di eventuali disturbi gastrici o di altri disturbi che possono interferire con l’assorbimento del farmaco per via orale.
    19.Ipersensibilità nota a qualsiasi eccipiente presente nella formulazione del farmaco in studio.
    20.Donne in gravidanza o allattamento.
    E 21. Donne in età fertile, a meno che non utilizzino un metodo contraccettivo efficace durante il trattamento.
    E 22. Uomini partner di donne in età fertile, a meno che non acconsentano ad utilizzare un metodo contraccettivo efficace durante il trattamento
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with absence of phlebotomy and hematocrit below 45% for a minimum of 3 months after completion of 8 cycles of therapy ET: Proportion of patients with a platelet count ≤ 400 x 10 exp9/L for a minimum of 3 months after completion of 8 cycles of therapy.
    • Policitemia vera
    Percentuale di pazienti con assenza di flebotomia ed ematocrito inferiore al 45% per un minimo di 3 mesi dopo il completamento di 8 cicli di terapia.
    • Trombocitemia essenziale
    Percentuale di pazienti con riduzione della conta piastrinica fino a ≤ 400 x 109/L per un minimo di 3 mesi dopo il completamento di 8 cicli di terapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    two years
    due anni
    E.5.2Secondary end point(s)
    Characterization of clinicohematologic response defined by European LeukemiaNet sustained for a minimum of 2 months after completion of 8 cycles of therapy. Percent change in spleen volume (per MRI) at the end of Cycles 4 and 8 or end of treatment (EOT) relative to baseline. Proportion of patients with a 35% reduction in spleen volume (per MRI) at the end of Cycles 4 and 8 or EOT relative to baseline Changes in histological, cytogenetic and molecular responses in bone marrow Response (defined as either a 2-point improvement in or resolution of a symptom present at baseline) at the end of Cycles 1, 4, and 8 or EOT, as measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF). To determine Cmax, Tmax, AUC0-24h of SAR302503, based on plasma concentrations from blood samples obtained, pre-dose and post-dose on Day 1 of Cycles 1 and 2, and pre-dose on Cycle 1 Days 2 and Cycle 3 Day 1. In patients with the JAK2V617F mutation, change in peripheral blood granulocyte JAK2V617F allele burden from baseline to the end of Cycles 4 and 8 or EOT STAT3 phosphorylation inhibition pre-dose and post-dose on C1D1 and pre-dose on C1D15 and C2D1
     Definizione della risposta clinico-ematologica in accordo ai criteri europei “Leukemia Net” mantenuta per un minimo di 2 mesi dopo il completamento di 8 cicli di terapia
     Variazione percentuale del volume della milza (misurato tramite Risonanza Magnetica) alla fine del ciclo 4 e 8 o alla visita di fine trattamento rispetto al basale.
     Percentuale di pazienti con una riduzione  35% del volume della milza (misurato tramite Risonanza Magnetica) alla fine del ciclo 4 e 8 o alla visita di fine trattamento rispetto al basale.
     Cambiamenti nella risposta istologica, citogenetica e molecolare del midollo osseo:
    a) nei pazienti che hanno raggiunto un’evidenza di risposta completa (CR) al momento della risposta completa e di nuovo dopo 6 mesi se sono ancora in risposta completa; b) nei pazienti con alterazioni citogenetiche al basale o con fibrosi reticolare, ogni 6 mesi.
     Risposta (definita come un miglioramento di 2 punti rispetto al basale o come risoluzione dei sintomi presenti al basale) alla fine dei cicli 1, 4, e 8 o alla visita di fine trattamento misurati dal questionario “Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)”.
    E.5.2.1Timepoint(s) of evaluation of this end point
    two years
    due anni
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 No
    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 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
    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 years0
    E.8.9.1In the Member State concerned months27
    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 months23
    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.1.1Number of subjects for this age range: 0
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 90
    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 Decision2011-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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