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    Summary
    EudraCT Number:2014-003876-22
    Sponsor's Protocol Code Number:CCDZ173X2201
    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:2021-01-05
    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 number2014-003876-22
    A.3Full title of the trial
    An open-label, non-randomized, within-patient dose-finding study followed by a randomized, subject, investigator and sponsor-blinded placebo controlled study to assess the efficacy and safety of CDZ173 (Leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/ p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
    Studio in aperto, non randomizzato, entro pazienti per la definizione della dose seguito da uno studio randomizzato, soggetto, medico e sponsor in cieco, controllato verso placebo, per valutare l’efficacia e la sicurezza di CDZ173 (Leniolisib) in pazienti con sindrome da attivazione di PIK3-delta/immunodeficienza, linfadenopatia e cellule T senescenti da mutazione attivante p110-delta (APDS/PASLI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the safety and efficacy of CDZ173 in patients with APDS/PASLI
    Studio per valutare sicurezza ed efficacia di CDZ173 in pazienti con APDS/PASLI
    A.3.2Name or abbreviated title of the trial where available
    Study of efficacy of CDZ173 in patients with APDS/PASLI
    Studio sull' efficacia di CDZ173 in pazienti con APDS/PASLI
    A.4.1Sponsor's protocol code numberCCDZ173X2201
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12345678
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT12345678
    A.5.3WHO Universal Trial Reference Number (UTRN)U1234-1234-1234
    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 SponsorNOVARTIS PHARMA SERVICES AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma S.p.A.
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni,1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number0296541
    B.5.5Fax number029659066
    B.5.6E-mailinfo.studiclinici@novartis.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 name-
    D.3.2Product code CDZ173
    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.3.8INN - Proposed INNCDZ173
    D.3.9.2Current sponsor codeCDZ173
    D.3.9.4EV Substance CodeSUB168935
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name-
    D.3.2Product code CDZ173
    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.3.8INN - Proposed INNCDZ173
    D.3.9.2Current sponsor codeCDZ173
    D.3.9.4EV Substance CodeSUB168935
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/ p110d-activating mutation causing senescent T cells, lymphadenopathy
    and immunodeficiency)
    APDS/PASLI (Sindrome da attivazione di PIK3-delta/immunodeficienza, linfadenopatia e cellule T senescenti da mutazione attivante p110-delta)
    E.1.1.1Medical condition in easily understood language
    Gain of function genetic mutation in the PI3K delta gene causing immunodeficiency
    Immunodeficienza causata da attivazione del gene PIK3-delta
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune 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
    ¿ Part I and Part II: To assess the safety and tolerability of CDZ173 in
    patients with APDS/PASLI
    ¿ In Part I: To assess the dose-PD and PK/PD relationship of CDZ173 in
    patients with APDS/PASLI for dose selection in Part II
    ¿ In Part II: To assess the clinical efficacy of CDZ173 in patients with
    APDS/PASLI
    Parte I: valutare la sicurezza e la tollerabilit¿ di CDZ173 come pure le relazioni dose-PD e PK/PD di CDZ173 in pazienti con APDS/PASLI permettendo la selezione della dose per la Parte II.
    Parte II: valutare l¿efficacia clinica di CDZ173 in pazienti con APDS/PASLI.
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetics of CDZ173 in patients with
    APDS/PASLI
    ¿ To assess the efficacy of CDZ173 to modify health-related quality of
    life in patients with APDS/PASLI
    ¿ To assess the efficacy of CDZ173 by the Physician's Global Assessment
    and the Patient's Global Assessment
    ¿ To assess biomarkers reflecting the efficacy of CDZ173 to reduce
    systemic inflammatory components of the disease
    ¿ To assess the treatment benefit to individual patients
    ¿Parte II: valutare l¿effetto di CDZ173 sulla linfoadenopatia (lesioni non indice e milza)
    Parte I e II: valutare la farmacocinetica di CDZ173 in pazienti con APDS/PASLI.
    Parte I and II: valutare l¿efficacia di CDZ173 nel modificare la qualit¿ della vita correlata alla salute in pazienti con APDS/PASLI.
    Parte I e II: valutare l¿efficacia di CDZ173 tramite i questionari Physician¿s Global Assessment e Patient¿s Global Assessment.
    Parte I e II: valutare gli indicatori biologici che riflettono l¿efficacia di CDZ173 nel ridurre i componenti infiammatori sistemici della malattia.
    Parte I e II: valutare il beneficio del trattamento per i singoli pazienti.
    Parte II: valutare la sicurezza e la tollerabilit¿ di CDZ173 su pazienti con APDS/PASLI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female patients age 12 to 75 years of age (inclusive), who have a documented APDS/PASLI-associated genetic PI3K delta mutation
    • In part I and part II, patients must have nodal and/or extranodal lymphoproliferation, and clinical findings and manifestations compatible with APDS/PASLI such as a history of repeated oto-sinopulmonary infections and/or organ dysfunction (e.g., lung, liver). In part II, patients must have, additionally, at least one nodal lesion on the CT or MRI scan at baseline described by the Cheson criteria.
    • At screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the patient has
    rested for at least three minutes. Sitting vital signs should be within the following ranges:
    ¿ Systolic blood pressure, 90-160 mm Hg
    ¿ Diastolic blood pressure, 50-95 mm Hg
    ¿ Pulse rate, 40 - 100 bpm
    • Pazienti di sesso maschile e femminile di età compresa tra 12 e 75 anni (estremi inclusi) con documentata APDS/mutazione genetica di PI3K-delta associata a PASLI.
    • Nella Parte I e nella Parte II, i pazienti devono avere linfoproliferazione nodale e/o extranodale, ed esiti e manifestazioni cliniche compatibili con APDS/PASLI, come un’anamnesi di infezioni oto-sino-polmonari ripetute e/o disfunzionalità d’organo (ad es. polmone, fegato). Nella Parte II i pazienti devono inoltre presentare almeno una lesione nodale alla TAC o MRI basale descritta dai criteri Cheson.
    • Allo screening, i segni vitali (pressione arteriosa sistolica e diastolica e frequenza cardiaca) saranno valutati in posizione seduta dopo che il paziente è rimasto a riposo per almeno 3 minuti. I segni vitali i posizione seduta devono rientrare nei seguenti limiti:
    ¿ Pressione arteriosa sistolica, 90-160 mm Hg
    ¿ Pressione arteriosa diastolica, 50-95 mm Hg
    ¿ Frequenza cardiaca, 40-100 bpm
    E.4Principal exclusion criteria
    • Use of unstable i.v. Ig / s.c. Ig in the last 6 months before screening. Stable maintenance immunoglobulin regimen, as per local practice, such as regular injections with a consistent dosing interval (e.g., monthly) injections is acceptable
    • Previous or concurrent use of immuno-suppressive medication such as:
    - use of an mTOR inhibitor (e.g., rapamycin, everolimus) or a PI3Kd inhibitor (selective or non-selective PI3K inhibitors) within 6 weeks prior to first dosing, however short-term use for up to a total of 5 days is allowed but only up to 1 month prior to enrollment in the study.
    - B cell depleters (e.g., rituximab) within 6 months prior to first dosing of study medication; if patients have received prior treatment with a B cell depleter, absolute B lymphocyte counts in the blood must have regained normal values.
    - Belimumab or cyclophosphamide within 6 months prior to first dosing of study medication.
    - Cyclosporine A, mycophenolate, 6-mercaptopurine, azathioprine or methotrexate within 3 months prior to first dosing of study medication.
    - Glucocorticoids above 10 mg prednisone or equivalent per day within 2 weeks prior to first dosing of study medication.
    - Other immunosuppressive medication where effects are expected to persist at start of dosing of study medication.
    • Patients currently being treated with medication known to be strong inhibitors or moderate or strong inducers of isoenzyme CYP3A, if treatment cannot be discontinued or switched to a different medication prior to starting study treatment.
    • Patients currently being treated with drugs that are metabolized by isoenzyme CYP1A2 and have a narrow therapeutic index (drugs whose exposure-response indicates that increases in their exposure levels by the concomitant use of potent inhibitors may lead to serious safety concerns (e.g., Torsades de Pointes)).
    • Administration of live vaccines (this includes any attenuated live vaccines) starting from 6 weeks before study entry, during the study and up to 7 days after the last dose of CDZ173
    • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
    • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective
    methods of contraception (excluding oral, patch, subcutaneous implant or injected hormonal contraceptives) during dosing of study medication
    and for 2 days after stopping study treatment.
    • Utilizzo di Ig per endovena/Ig per via sottocutanea non stabile nei 6 mesi precedenti lo screening. Il regime di mantenimento stabile con immunoglobuline, in base alla pratica locale, come iniezioni regolari con un intervallo di somministrazione consistente (ad es. mensilmente) è accettabile.
    ¿ Uso pregresso o concomitante di immunosoppressori quali:
    un inibitore mTOR (ad es. sirolimus, rapamicina, everolimus) o di un inibitore PI3K-delta (inibitori selettivi o non selettivi di PI3K-delta) nelle 6 settimane precedenti alla prima somministrazione, tuttavia l’utilizzo a breve termine per un massimo di 5 giorni totali è consentito, ma solo fino ad un mese prima dell’arruolamento nello studio.
    ¿ Farmaci depletanti le cellule B (ad es. rituximab) nei 6 mesi precedenti la prima dose di farmaco dello studio; se i pazienti hanno ricevuto una precedente terapia con un farmaco depletante le cellule B, la conta assoluta dei linfociti B nel sangue deve essere ritornata entro il range di normalità.
    ¿ Belimumab o ciclofosfamide nei 6 mesi precedenti la prima dose di farmaco dello studio.
    ¿ Ciclosporina A, micofenolato, 6-mercaptopurina, azatioprina o metotressato nei 3 mesi precedenti la prima dose di farmaco dello studio.
    ¿ Glucocorticoidi oltre i 10 mg di prednisone o equivalente al giorno nelle 2 settimane precedenti la prima dose di farmaco dello studio.
    ¿ Altri farmaci immunosoppressori i cui effetti ci si aspetta che persistano al momento di inizio della terapia con il farmaco dello studio.
    ¿ Pazienti attualmente in trattamento con farmaci noti per essere potenti inibitori o moderati o potenti induttori dell’isoenzima CYP3A, se il trattamento non può essere interrotto o se non è possibile passare ad un diverso trattamento prima dell’inizio del trattamento in studio.
    ¿ Pazienti attualmente in trattamento con farmaci che vengono metabolizzati dall’isoenzima CYP1A2 e che hanno uno stretto indice terapeutico (farmaci il cui rapporto esposizione-risposta indica che aumenti nei relativi livelli di esposizione dati dal trattamento concomitante di potenti inibitori possono portare a serie preoccupazioni di sicurezza (ad es. torsioni di punta))
    ¿ Somministrazione di vaccini vivi (compreso qualsiasi vaccino vivo attenuato) a partire da 6 settimane prima dell’ingresso in studio, durante lo studio e fino a 7 giorni dopo l’ultima somministrazione di CDZ173.
    ¿ Donne in gravidanza o allattamento, con la gravidanza definita come lo stato di una donna dopo il concepimento e fino al termine della gestazione, confermato da un test di laboratorio positivo per hCG.
    ¿ Donne potenzialmente fertili, definite come tutte le donne fisiologicamente in grado di iniziare una gravidanza, a meno che non utilizzino metodi contraccettivi di efficacia elevata durante la somministrazione del trattamento in studio e per i 2 giorni successivi all’interruzione del trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    • Part I and Part II: All safety parameters (including AEs, physical exam, vital signs, ECG, safety laboratory (hematology, blood chemistry,
    urinalysis))
    • In Part I: Single and multiple dose concentrations of CDZ173 and pAkt inhibition in unstimulated and stimulated whole blood
    • In Part II: Reduction of lymphadenopathy in the index lesions selected as per the Cheson methodology from MRI/CT imaging.
    Parte I e Parte II: tutti i parametri di sicurezza (Eventi Avversi, esame fisico, segni vitali, ECG, esami di laboratorio (Ematologia, biochimica, esami urine))
    • Parte I: concentrazione di CDZ173 e inibizione di pAkt nel sangue intero stimolato e non stimolato
    Parte II: riduzione di linfoadenopatia valutata tramite MRI o TAC utilizzando al metodologia di Cheson
    E.5.1.1Timepoint(s) of evaluation of this end point
    From beginning to end of study
    Dall'inizio alla fine dello studio
    E.5.2Secondary end point(s)
    ¿ Single dose CDZ173 PK parameters (including but not limited to Cmax and AUC) and trough evaluations after multiple dose; ¿ SF-36 (Short Form 36) Survey and WPAI-CIQ (Work Productivity; Visual analogue scales for PGA and PtGA; C reactive protein (CRP), Lactate dehydrogenase (LDH); Narratives
    -parametri di PK per dose singola e multipla (compresi, ma non limitati a Cmax e AUC)
    ; -Questionario SF-36 e WPAI-CIQ; Scala visivo-analogica per le valutazioni globali del paziente e del medico ; Proteina C reattiva (CRP) e Lattato Deidrogenasi (LDH); Narrativa del paziente
    E.5.2.1Timepoint(s) of evaluation of this end point
    From beginning to end of study; From beginning to end of study; From beginning to end of study; From beginning to end of study; From beginning to end of study
    Dall'inizio alla fine dello studio; Dall'inizio alla fine dello studio; Dall'inizio alla fine dello studio

    ; Dall'inizio alla fine dello studio

    ; Dall'inizio alla fine dello studio
    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 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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Parte I: in aperto con titolazione entro paziente, per dose-finding.
    Part I : non-randomized, open-label, within patients up titration dose findings
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    United States
    Czechia
    Netherlands
    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
    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 months10
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days15
    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: 11
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 36
    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)
    Routine care
    Normale pratica clinica
    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 Decision2016-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-16
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