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    Summary
    EudraCT Number:2011-001354-29
    Sponsor's Protocol Code Number:I10E-0719
    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:2012-03-07
    Trial results Removed from public view
    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 number2011-001354-29
    A.3Full title of the trial
    An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)
    Studio multicentrico, in aperto, sull`™efficacia e la sicurezza di I10E in pazienti affetti da trombocitopenia immune primaria (ITP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)
    Studio sull'efficacia e la sicurezza di I10E in pazienti affetti da trombocitopenia immune primaria (ITP)
    A.4.1Sponsor's protocol code numberI10E-0719
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/184/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLFB BIOTECHNOLOGIES
    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 supportLFB BIOTECHNOLOGIES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPremier Research group srl
    B.5.2Functional name of contact pointStart-up
    B.5.3 Address:
    B.5.3.1Street AddressVia Winckelmann 2
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20146
    B.5.3.4CountryItaly
    B.5.4Telephone number0248958768
    B.5.5Fax number0248959776
    B.5.6E-mailstefania.giovanelli@premier-research.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 namehuman normal immunoglobulin for intravenous use
    D.3.2Product code I10E
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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
    ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria
    adopting the new consensus terminology proposed by an international
    working group (Rodeghiero et al, 2009)
    Diagnosi di TIP definita dai criteri ASH-2011 e BCSH 2010 adottando la nuova terminologia accettata consensualmente, proposta da un gruppo di lavoro internazionale (Rodeghiero et al., 2009)
    E.1.1.1Medical condition in easily understood language
    treatment of Immune thrombocytopenia (a group of disorders
    characterized by autoimmune destruct. of platelet and insuff.
    platelet production leading to an increased risk of bleeding)
    Trattamento della trombocitopenia immune(gruppo di disordini caratt. dalla distruz.autoimmune e la produzione insuff. di piatrine che può portare ad un rischio maggiore di sanguin.)
    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 LLT
    E.1.2Classification code 10023095
    E.1.2Term ITP
    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 assess the efficacy of I10E in increasing platelet count and controlling
    bleedings in patients suffering from primary Immune ThrombocytoPenia
    (ITP).
    valutare l’efficacia di I10E nell’aumentare la conta piastrinica e nel controllare gli episodi emorragici in pazienti affetti da trombocitopenia immune primaria (ITP).
    E.2.2Secondary objectives of the trial
    To assess the biological and clinical safety profile of I10E.
    valutare il profilo di sicurezza biologico e clinico di I10E.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Both genders
    2. Age between 18 to 65 year old
    3. Chronic Primary ITP
    - ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria
    adopting the new consensus terminology proposed by an international
    working group (Rodeghiero et al, 2009):
    ▪ Isolated thrombocytopenia diagnosed with platelet count
    <100 x 10exp9/l and no abnormality of cells of other haematological
    lineage and,
    ▪ Normal bone marrow (if available), or history of response to an
    ITP treatment (corticosteroids, IVIg, anti-D) and,
    ▪ Failure to find any other causes of thrombocytopenia.
    - Chronic ITP with bleeding(s) or an increased risk of bleeding:
    ▪ More than 12 months from diagnosis of ITP and,▪ Platelet counts < 30 x 10exp9/l at the time of inclusion.
    Note: Refractory ITP may be included and is defined by the failure to
    achieve a response or by the loss of response after splenectomy and the
    need of treatment (s) to minimize the risk of bleeding considered as
    clinically
    significant by the investigator.
    4. Written informed consent.
    5. Patient is covered by health care insurance system.
    1. sono idonei allo studio soggetti di entrambi i sessi;
    2. età compresa tra i 18 e i 65 anni, entrambi inclusi;
    3. ITP primaria cronica:
     la diagnosi di ITP viene definita in base ai criteri ASH-2011 e BCSH 2010 adottando la nuova terminologia accettata consensualmente, proposta da un gruppo di lavoro internazionale (Rodeghiero et al., 2009):
    ▪ trombocitopenia isolata diagnosticata con conta piastrinica &lt;100 x 109/l e nessuna anomalia cellulare di altre linee ematologiche;
    ▪ midollo osseo normale (se disponibile) o precedenti di risposta a un trattamento per ITP (corticosteroidi, IVIg, anti-D);
    ▪ impossibilità di identificare altre cause di trombocitopenia.
     ITP cronica con emorragia/e o aumento del rischio di emorragia:
    ▪ trascorsi oltre 12 mesi dalla diagnosi di ITP;
    ▪ conte piastriniche &lt; 30 x 109/l al momento dell’inclusione.
    Nota: l’ITP refrattaria può essere inclusa ed è definita dall’incapacità di ottenere una risposta o dalla perdita di risposta in seguito a splenectomia e dalla necessità di trattamento/i al fine di minimizzare i rischi di emorragia ritenuti clinicamente significativi dallo sperimentatore.
    4. consenso informato scritto;
    5. il paziente deve essere coperto dal sistema assicurativo sanitario.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to the active substance or to any of the
    excipients.
    2. Patient with IgA deficiency except if the absence of anti IgA
    antibodies is documented.
    3. History of cardiac insufficiency (NYHA III/IV), cardiomyopathy,
    congestive heart failure, or severe hypertension (sbp> or = to160 mmHg and dbp> or = to 100 mmHg).
    4. History of thrombotic episodes (including deep vein thrombosis,
    myocardial infarction, cerebrovascular accident, pulmonary embolism)
    within the last 12 months.
    5. Patient known to be infected with hepatitis B, C virus,
    or human immunodeficiency virus.
    6. Treatment that could induce thrombocytopenia within 15 days prior to
    inclusion.
    7. Recent previous treatment, the action of which may interfere with the
    assessment of the investigational medicinal product:
    - Initiation of corticosteroids or regular increase in the steroid dose
    within the last 4 weeks,
    - IVIg within the last 4 weeks,
    - Anti-D within the last 4 weeks,
    - Cyclosporin A within 4 weeks,
    - Immunomodulator (as vincristin, vinblastin) within the last month,
    - Immunosuppressor (azathioprine, cyclophosphamide) within the last 4
    weeks,
    - Anti-CD20 (rituximab) within the last 4 months,
    - Antigonadotropin Hormone (danazol) within the last 6 months,
    - Thrombopoietin receptors agonist (eltrombopag, romiplostim) within
    the last 4 weeks,
    8. Splenectomy required during the study period or within the two
    previous months.
    9. Severe haemorrhagic syndrome whether life-threatening or not, such
    as intracranial haemorrhage, gastrointestinal haemorrhage,
    gynaecological
    haemorrhage with deglobulisation of more than 2g/dL or major
    cutaneous-mucosal haemorrhagic syndrome.
    10. Severe bleeding requiring platelets transfusion at time of inclusion,
    or whole blood transfusion.
    11. Plasma exchange 4 weeks before inclusion.
    12. Concomitant disease that may induce a secondary immune
    thrombocytopenia, as:
    - Clinical active systemic lupus erythematous with more than 4 American
    College of Rheumatology criteria,
    - Lymphoproliferative disease or active malignant condition requiring
    antineoplastic or cytotoxic treatment.
    13. Known hepatic disorder including total bilirubin > 2 x upper limit of
    normal range, alanine aminotransferase (ALT) or aspartate amino
    transferase (AST) > 3 x upper limit of normal range.
    14. Known chronic renal insufficiency or creatinine clearance values < 80
    ml/min in adult patients (Modified Diet in Renal Disease calculation).
    15. Medical history of haemolysis or haemolytic anaemia during prior
    IVIg therapy or any other concomitant disease of clotting system.
    16. Administration of another investigational medicinal product within the last month.
    17. Any serious medical condition that would interfere with the clinical
    assessment of I10E or prevent the patient to comply with the protocol
    requirements.
    18. Pregnant with positive results pregnancy urinary test or
    breastfeeding woman, or woman of childbearing potential without
    effective contraception (effective contraception are: injectable, patch or
    combined oral estro-progestative or progestative contraceptives, intra-uterine devices of type 'copper T' and levonorgest releasing IU systems, depot
    intramuscular medroxyprogesteron, subcutaneous implants of
    progestative contraceptives implants).
    19. Anticipated poor compliance of patient with study procedures.
    20. Use of loop diuretics within a week prior the inclusion.
    21. History of alcohol or drug abuse.
    22. Previously included /enrolled in this clinical study.
    23. Body Mass Index ≥ 30 kg/m2
    1.ipersensibilità nota al principio attivo o ad uno qualsiasi degli eccipienti;
    2.pazienti con deficit di IgA, fatta salva l’eventualità in cui l’assenza di anticorpi anti IgA sia documentata;
    3.anamnesi di insufficienza cardiaca (N.Y.H.A. classe III e IV), cardiomiopatia, scompenso cardiaco congestizio o grave ipertensione (pas &gt; 160 mmHg e pad&gt; 100 mmHg);
    4.precedenti di episodi trombotici (compresi trombosi venosa profonda, infarto del miocardio, incidente cerebrovascolare ed embolia polmonare) negli ultimi 12 mesi;
    5.infezione nota del paziente da virus dell’epatite B, C o virus dell’immunodeficienza umana;
    6.trattamento che potrebbe indurre trombocitopenia nei 15 gg precedenti l’inclusione;
    7.recente trattamento precedente la cui azione potrebbe interferire con la valutazione del prodotto medicinale sperimentale:
    inizio della somministrazione di corticosteroidi o regolare aumento della dose di steroidi nelle ultime 4 settimane;
    IVIg nelle ultime 4 settimane;
    anti-D nelle ultime 4 settimane;
    ciclosporina A nelle ultime 4 settimane;
    immunomodulatori (quali vincristina e vinblastina) nell’ultimo mese;
    immunosoppressori (azatioprina, ciclofosfamide) nelle ultime 4 settimane;
    anti-CD20 (rituximab) negli ultimi 4 mesi;
    ormone antigonadotropo (danazolo) negli ultimi 6 mesi;
    agonisti dei recettori della trombopoietina (eltrombopag, romiplostim) nelle ultime 4 sett.;
    8.richiesta di splenectomia durante il periodo dello studio o nei due mesi precedenti;
    9.grave sindrome emorragica, in grado di rappresentare o meno una minaccia per la vita, quale emorragia intracranica, emorragia gastrointestinale, emorragia ginecologica con deglobulizzazione superiore a 2g/dl o sindrome emorragica cutaneo-mucosica grave;
    10.grave emorragia che richieda una trasfusione di piastrine o di sangue intero all’epoca dell’inclusione;
    11.plasma exchange 4 settimane prima dell’inclusione;
    12.patologia concomitante che possa indurre una trombocitopenia immune secondaria, quale:
    lupus eritematosus sistemico clinicamente attivo per la diagnosi del quale si è risposto a oltre 4 criteri proposti dall’American College of Rheumatology;
    patologia linfoproliferativa o malattia maligna attiva tale da richiedere un trattamento antineoplastico o citotossico;
    13.patologia epatica nota compresi livelli di bilirubina totale 2 volte superiori al limite superiore della norma e livelli di ALT o AST 3 volte superiori al limite superiore della norma;
    14.insufficienza renale cronica nota o valori di clearance della creatinina &lt; 80 ml/min in pazienti adulti;
    15.anamnesi di emolisi o anemia emolitica durante precedente terapia IVIg o altra malattia concomitante del sistema di coagulazione del sangue (ad es. emofilia);
    16.somministrazione di altro prodotto medicinale sperimentale nell’ultimo mese;
    17.qualsiasi altra grave patologia che potrebbe interferire con la valutazione clinica dell’I10E o tale da pregiudicare la capacità del paziente di rispettare le richieste del protocollo;
    18.gravidanza confermata da esame urinario positivo e donne in fase di allattamento o in età fertile che non fanno uso di efficaci sistemi contraccettivi
    19.previsione di scarsa compliance del paziente alle procedure dello studio;
    20.utilizzo di diuretici dell’ansa nella settimana precedente all’inclusione;
    21.precedenti di abuso d'alcol o di sostanze stupefacenti;
    22.precedente inclusione/arruolamento nel presente studio clinico.
    23.Indice di massa Corporea &gt; 30 kg/m2
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number and percentage of patients with
    responses (including complete responses) during the investigational
    period.
    Patients with response (R):
    - Platelet counts > or = to 30 x 10 exp9/l and at least 2-fold increase of
    baseline platelet count confirmed on at least 2 separate visits at least 7
    days apart.
    - And absence of new bleeding.
    · Patients with complete response (CR):
    - Platelet count > or = to 100 x 10 exp9/l, confirmed on at least 2
    separate visits at least 7 days apart.
    - And absence of new bleeding.
    L’endpoint primario è rappresentato dal numero e dalla percentuale di pazienti che esibiscono risposte (comprese risposte complete) durante il periodo di sperimentazione.
    I tipi di risposta sono così definiti:
    • Pazienti che esibiscono risposta (R):
     conte piastriniche  30 x 109/l e un aumento almeno doppio della conta piastrinica al basale confermato in occasione di almeno 2 visite separate a distanza di almeno 7 giorni l’una dall’altra;
    e
     assenza di nuova emorragia.
    • Pazienti che esibiscono risposta completa (CR):
     conta piastrinica  100 x 109/l, confermata in occasione di almeno 2 visite separate a distanza di almeno 7 giorni una dall’altra;
    e
     assenza di nuova emorragia.
    • Pazienti che non esibiscono risposta (NR):
     conta piastrinica < 30 x 109/l o aumento di meno del doppio della conta piastrinica al basale confermato in occasione di almeno 2 visite separate a circa 1 giorno di distanza l’una dall’altra;
    o
     insorgenza di una nuova emorragia.
    • Pazienti con perdita di CR o di R:
     conta piastrinica < 100 x 109/l (da CR) o conta piastrinica < 30 x 109/l o aumento di meno del doppio della conta piastrinica al basale (da R). Conta piastrinica confermata in occasione di almeno 2 visite separate a distanza di circa 1 giorno una dall’altra;
    o
     insorgenza di una nuova emorragia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    confirmed on at least 2 separate visits at least 7 days apart during the
    study period.
    Confermata in alemno 2 visite separate a distanza di almeno 7 giorni durante il periodo di studio
    E.5.2Secondary end point(s)
    Efficacy criteria:
    - Number and % of patients with complete response (CR) during the
    investigational period.
    - Time to response i.e. time from starting treatment to time of platelet
    response achievement (platelet count > or = to 30 x 10 exp9/l) in the
    responder
    population.
    - Maximum platelet counts and time to reach the maximum platelet
    count.
    - Number and % of non-responders patients (NR) during the
    investigational period.
    - Number and % of patients with a loss of R and CR during the
    investigational period.
    - Duration of response defined as the number of days from the first day
    of the response (CR or R) to the first day of the loss of response (CR or
    R).
    - Number and % of patients with platelet count > or = to 50 x 10 exp9/l
    at Day 5, Day 6 and Day 7.
    - Evaluation of pre-existing bleedings (Khellaf score and WHO score
    assessed at baseline, Day 2, Day 14 and Day 30)
    • Criteri di efficacia:
     numero e percentuale di pazienti con risposta completa (CR) durante il periodo sperimentale;
     tempo alla riposta, ovvero tempo che intercorre tra l’inizio del trattamento e il momento in cui si ottiene la risposta piastrinica (conta piastrinica  30 x 109/l) nella popolazione rispondente;
     conte piastriniche massime e tempo necessario per raggiungere la massima conta piastrinica;
     numero e percentuale di pazienti non-rispondenti (NR) durante il periodo di sperimentazione;
     numero e percentuale di pazienti con una perdita di R e di CR durante il periodo di sperimentazione;
     durata della risposta definita come il numero di giorni trascorsi dal primo giorno della risposta (CR o R) al primo giorno della perdita di risposta (CR o R);
     numero e percentuale di pazienti con conta piastrinica  50 x 109/L al Giorno 5, al Giorno 6 e al Giorno 7;
     valutazione di emorragie preesistenti (score di rischio emorragico Khellaf e score OMS valutati al basale, al Giorno 2, al Giorno 14 e al Giorno 30)
    E.5.2.1Timepoint(s) of evaluation of this end point
    see details provided in section Secondary end-point
    vedere per i dettagli la sezione End point secondario
    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 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 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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Russian Federation
    Ukraine
    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
    End of the study will be last patient last visit
    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 months13
    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 months13
    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: 40
    F.1.3Elderly (>=65 years) No
    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 30
    F.4.2.2In the whole clinical trial 40
    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 last visit patients will be switched to the normal standard of care for the condition
    All'ultima visita i pazienti verranno ricondotti alle cure standard per la loro condizioni
    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 Decision2011-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-29
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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