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    Summary
    EudraCT Number:2016-003876-29
    Sponsor's Protocol Code Number:GMPO-131-002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003876-29
    A.3Full title of the trial
    CHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease
    STUDIO CHELATE: Trientina Tetracloridrato (TETA 4 HCl) nel trattamento della malattia di Wilson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chelate Study: Trientine for the treatment of Wilson's disease
    Trientina Tetracloridrato (TETA 4 HCl) nel trattamento della malattia di Wilson
    A.3.2Name or abbreviated title of the trial where available
    Chelate Study: Trientine for the treatment of Wilson's disease
    Trientina Tetracloridrato (TETA 4 HCl) nel trattamento della malattia di Wilson
    A.4.1Sponsor's protocol code numberGMPO-131-002
    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.5.4Other Identifiers
    Name:GMPO-131-002Number:GMPO-131-002
    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 SponsorGMP ORPHAN SA
    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 supportgmp-orphan SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationgmp-orphan SA
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressPépinière Paris Santé Cochin, 27-29 rue Faubourg
    B.5.3.2Town/ citySaint-Jacques - Paris
    B.5.3.3Post code75014
    B.5.3.4CountryFrance
    B.5.4Telephone number0033142498264
    B.5.5Fax number0
    B.5.6E-mailnaseem@gmp-o.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/3/15/1471
    D.3 Description of the IMP
    D.3.1Product nameTETA.4HCI
    D.3.2Product code TETA.4HCI
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrientine tetrahydrochloride
    D.3.9.1CAS number 4961-40-4
    D.3.9.2Current sponsor codeTETA4HCI
    D.3.9.4EV Substance CodeSUB77343
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name PEMINE - 150 MG CAPSULE RIGIDE 50 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY ITALIA S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INND-penicillamine
    D.3.9.1CAS number 52-67-5
    D.3.9.2Current sponsor codeD-penicillamine
    D.3.9.4EV Substance CodeSUB09667MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
    La Malattia di Wilson (WD) è una malattia genetica, autosomica recessiva, le cui manifestazioni cliniche dipendono dall'accumulo di rame principalmente a livello del fegato e del cervello.
    E.1.1.1Medical condition in easily understood language
    Excessive copper accumulation
    Accumulo eccessivo di rame
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047988
    E.1.2Term Wilson's disease
    E.1.2System Organ Class 100000004850
    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 TETA 4HCl compared to penicillamine.
    Valutare l'efficacia di TETA 4HCI confrontata a penicillamina
    E.2.2Secondary objectives of the trial
    The safety of TETA 4HCl compared to penicillamine will also be evaluated.
    Sarà valutata la sicurezza di TETA 4HCI confrontata a penicillamina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is able to provide and has provided written informed consent has been obtained
    2. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable, including for EU sites, Data Protection Consent
    3. Male or female, aged ≥ 18 and ≤ 75 years old at time of consent
    4. Patient has a diagnosis of Wilson’s disease, as defined by a prior or current Leipzig score of ≥ 4
    5. Patient’s Wilson’s disease is clinically stable, in the opinion of the investigator, and being treated with penicillamine for at least 1 year (52 weeks) prior to the screening visit
    6. Patient is on a stable dose and regimen of penicillamine for at least 4 months (16 weeks) prior to the screening visit (other prescribed treatments for Wilson’s disease not permitted during this period)
    7. No anticipated need that patient will require additional pharmacological therapies other than study medication, including prescribed zinc therapy, for the management of copper levels during the study
    8. Patient must be willing to maintain stable diet throughout the study, and avoid foods with high copper content, including the screening period
    9. Patient considered suitable to receive therapy with both TETA 4HCl and penicillamine administered twice a day
    10. Negative central laboratory tests for HIV and viral hepatitis (results will be available after start of run-in period)
    11. For female patients of childbearing potential, negative urine pregnancy test (at screening visit and prior to randomization)
    12. For females of childbearing potential, use of a reliable form of contraceptive
    13. Patient is considered as able to complete study requirements and attend the study visits, in he opinion of the investigator
    1.Il paziente è in grado di fornire,e ha fornito, un consenso informato scritto.
    2.È stata ottenuta la documentazione scritta in conformità ai requisiti nazionali e locali in materia di tutela della privacy, laddove pertinente, tra cui per i centri europei: Consenso in materia di protezione dei dati
    3.Pazienti di ambo i sessi, di età ≥ 18 e ≤ 75 anni al momento del consenso
    4.Al paziente è stata diagnosticata la malattia di Wilson, definita da un punteggio di Leipzig precedente o attuale ≥ 4
    5.La malattia di Wilson del paziente è clinicamente stabile, secondo il giudizio dello sperimentatore, ed è trattata con penicillamina da almeno 1 anno (52 settimane) al momento della visita di screening
    6.Il paziente segue un regime a base di penicillamina a dosaggio stabile da almeno 4 mesi (16 settimane) al momento della visita di screening (in questo periodo non sono consentiti altri trattamenti prescritti per la malattia di Wilson)
    7. Non si prevede la necessità di somministrare al paziente altre terapie farmacologiche oltre al farmaco dello studio, compresa terapia a base di zinco prescritta, per la gestione dei livelli di rame nel corso dello studio
    8.Il paziente deve essere disposto a mantenere una dieta stabile per l’intera durata dello studio e a evitare alimenti a elevato contenuto di rame, anche durante il periodo di screening
    9.Il paziente è ritenuto idoneo a ricevere una terapia sia con TETA 4 HCl sia con penicillamina somministrata due volte al giorno
    10.I risultati delle analisi del laboratorio centrale relative a HIV ed epatite virale sono negativi (i risultati saranno disponibili dopo l’inizio del periodo di run-in)
    11.Per le pazienti in età fertile, risultato negativo del test di gravidanza sulle urine (eseguito alla visita di screening e prima della randomizzazione)
    12.Per le pazienti in età fertile, utilizzo di un metodo contraccettivo affidabile
    13.Il paziente è ritenuto in grado, secondo il giudizio dello sperimentatore, di completare le procedure dello studio e di sottoporsi alle visite previste dallo studio
    E.4Principal exclusion criteria
    1. Patient is in ‘de-coppering’ phase of treatment for Wilson’s disease, in the opinion of the investigator
    2. Patient evidence of uncontrolled liver disease, including but not limited to:
    a. Modified Nazer score of ≥ 4 (result may not be available until after start of run-in period on lab results*)
    b. decompensated cirrhosis
    c. acute hemolytic anemia
    d. acute hepatitis
    e. hepatic malignancy
    f. evidence of acute liver failure
    3. Cause of patient’s liver disease is due to another condition, in the investigator’s opinion
    4. Patient has severe anemia defined as hemoglobin of ≤ 9 g/dL (result will be available after start of run-in period*)
    5. Patient has experienced a gastrointestinal bleed within 6 months (24 weeks) prior to screening visit
    6. Patient has moderate or severe renal impairment defined as creatinine clearance of ≤ 30 mL/min (result will may not be available until after start of run-in period*), or patient has nephritis or nephrotic syndrome, in the opinion of the investigator
    7. Patient has neurological disease that prevents swallowing of study medication (e.g. requires a nasogastric feeding tube) or requires intensive in-patient medical care
    8. Patient is currently taking medication containing trientine for management of Wilson’s disease or has taken it within 4 months (16 weeks) of screening visit
    9. Patient is currently receiving prescribed zinc therapy for management of Wilson’s disease or has taken it within 4 months (16 weeks) of screening visit
    10. Patient is taking any of the following concomitant therapies: gold therapy, antimalarial therapy, cytotoxic drugs, oxyphenbutazone, phenyl butazone
    11. Patient has a known intolerance, allergy or sensitivity to penicillamine (that is uncontrolled) or to TETA 4HCl, including any component of the study medication
    12. For female patients of childbearing potential, planning a pregnancy during study period or currently nursing
    13. For female patients of childbearing potential, unable or unwilling to use a reliable form of contraceptive throughout the study
    14. Patient is currently participating in another therapeutic study, or has previously participated in a therapeutic study within 30 days of screening visit (or longer, if local requirements specify this)
    15. Patient has any condition or in any situation which, in the investigator’s opinion, puts the patient at significant risk, could confound study results, or may interfere significantly with the patient’s participation in the study

    *Samples for screening/enrolment labs can be taken within ± 7 days of visit. In the event that lab value is above the specified threshold, it can be repeated. If repeat value within specified range, patient can continue in the study, otherwise the patient will be a screen failure. Note: if it is not possible to obtain a repeat value prior to the Week 4 clinic visit, then the Week 4 value will serve as the repeat lab value(s).
    1.Il paziente si trova, secondo il giudizio dello sperimentatore, nella fase di trattamento per la malattia di Wilson di riduzione dei livelli di rame
    2.Segni e sintomi di una malattia epatica non controllata, inclusi a titolo esemplificativo e non esaustivo i seguenti:
    a.Punteggio di Nazer modificato ≥ 4 (il risultato potrebbe non essere disponibile fino a dopo l’inizio del periodo di run-in perché è basato sui risultati degli esami di laboratorio*)
    b.Cirrosi scompensata
    c.Anemia emolitica acuta
    d.Epatite acuta
    e.Neoplasia epatica maligna
    f.Evidenza d’insufficienza epatica acuta
    3.Secondo il giudizio dello sperimentatore, la causa della malattia epatica è da ricercarsi in un’altra patologia
    4.Il paziente presenta anemia grave, definita da livelli di emoglobina ≤ 9 g/dl (i risultati saranno disponibili dopo l’inizio del periodo di run-in*)
    5.Il paziente ha manifestato un sanguinamento gastrointestinale nei 6 mesi (24 settimane) precedenti la visita di screening
    6.Il paziente ha una funzione renale compromessa, definita da una clearance della creatinina ≤ 30 ml/min (i risultati potrebbero non essere disponibili fino a dopo l’inizio del periodo di run-in*) oppure soffre, a giudizio del sperimentatore, di nefrite o di sindrome nefrosica
    7.Il paziente è affetto da una malattia neurologica che gli impedisce di ingerire il farmaco dello studio (ad es. necessita di un sondino nasogastrico) oppure ha bisogno di cure mediche intensive in regime di ricovero ospedaliero
    8.Il paziente è attualmente in trattamento con un farmaco contenente trientina per la gestione della malattia di Wilson o è stato in trattamento con tale farmaco nei 4 mesi (16 settimane) precedenti la visita di screening
    9.Il paziente è attualmente in terapia con zinco prescritta per la gestione della malattia di Wilson o l’ha assunta nei 4 mesi (16 settimane) precedenti la visita di screening
    10.Il paziente è attualmente in trattamento con una delle seguenti terapie concomitanti: oro terapia, terapia antimalarica, farmaci citotossici, ossifenbutazone, fenilbutazone
    11.Il paziente presenta una nota intolleranza, allergia o sensibilità alla penicillamina (non controllata) o al TETA 4 HCl, incluso qualsiasi componente del farmaco dello studio
    12.Per le pazienti di sesso femminile, gravidanza programmata durante il periodo dello studio o attuale allattamento al seno
    13.Per le pazienti di sesso femminile in età fertile, incapacità o riluttanza a utilizzare un metodo contraccettivo affidabile durante l’intero studio
    14.Attuale partecipazione a un altro studio terapeutico oppure partecipazione a uno studio terapeutico nei 30 giorni precedenti la visita di screening (o un periodo più lungo, se specificato dai requisiti locali)
    15.Il paziente presenta, a giudizio del sperimentatore, una condizione o una situazione che comporta un rischio significativo, potrebbe confondere i risultati dello studio o potrebbe interferire in maniera significativa con la sua partecipazione allo studio

    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of TETA 4HCl compared to penicillamine:
    The primary hypothesis is that the efficacy of TETA 4HCl, as assessed by serum NCC levels, is not inferior to the efficacy of penicillamine, at 36 weeks of treatment.
    The secondary efficacy measures are:
    - 24-hour urinary copper excretion
    - CGIC score
    Other efficacy measures are:
    - Unified Wilson’s Disease Rating Scale (UWDRS), neurological scale
    - Serum total copper and serum ceruloplasmin (used to derive non-ceruloplasmin bound copper).
    Significance tests will be performed at the α = 0.05 significance level for two-tailed tests at a= 0.025 for one tailed test
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured at Screening/Enrolment, Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
    E.5.2Secondary end point(s)
    The safety of TETA 4HCl compared to penicillamine will also be evaluated
    Safety will be evaluated by assessing treatment emergent AEs (TEAEs), and other safety measures (vital signs, hematology, biochemistry, coagulation analysis, urinalysis, modified Nazer score, and urine pregnancy test).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured at Screening, Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 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 No
    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 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 EEA12
    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
    Austria
    Brazil
    Denmark
    France
    Germany
    Italy
    Micronesia, Federated States of
    Poland
    United Kingdom
    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
    End of the study: The study ends with the last visit of the last patient participating in the study.
    Fine dello studio: Lo studio finisce con l'ultima visita dell'ultimo paziente partecipante nello studio
    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 months32
    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 months32
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 55
    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)
    All patients who end their participation in the study will continue to be monitored by their respective physicians, using standard of care. No special procedure or extra medical care is needed after the trial that would not be otherwise used in patients who have not participated in the trial.
    Tutti i pazienti che terminano lo studio continueranno ad essere monitorati dai loro rispettivi medici, secondo la normale pratica clinica. Non sono previste procedure speciali o cure mediche extra oltre a quelle effettuate normalmente sui pazienti che non hanno partecipato allo studio.
    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 Decision2017-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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