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    Summary
    EudraCT Number:2021-000136-59
    Sponsor's Protocol Code Number:KVD824-201
    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:2021-07-27
    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 number2021-000136-59
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II
    Sperimentazione di fase 2, randomizzata, in doppio cieco, controllata con placebo per valutare l’efficacia e la sicurezza di tre livelli di dosaggio di KVD824, un inibitore orale della callicreina plasmatica, per il trattamento profilattico a lungo termine dell’angioedema ereditario di tipo I o II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.
    Studio volto a valutare se differenti dosaggi di KVD824 sono efficaci nella prevenzione degli attacchi di Angioedema ereditario di tipo I o II
    A.3.2Name or abbreviated title of the trial where available
    N/A
    N/A
    A.4.1Sponsor's protocol code numberKVD824-201
    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 SponsorKalVista Pharmaceuticals Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportKalvista Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKalVista Pharmaceuticals Ltd
    B.5.2Functional name of contact pointKalVista Clinical
    B.5.3 Address:
    B.5.3.1Street AddressPorton Down Science Park, Bybrook Road
    B.5.3.2Town/ cityPorton Down, Salisbury
    B.5.3.3Post codeSP4 0BF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441980619368
    B.5.6E-mailclinical@kalvista.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 nameKVD824 300 mg Compresse a rilascio modificato
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Modified-release tablet
    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 codeKVD824.HCl
    D.3.9.3Other descriptive nameKVD824 hydrochloride
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release tablet
    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
    Hereditary Angioedema Type I or II
    Angioedema ereditario di tipo I o II
    E.1.1.1Medical condition in easily understood language
    Hereditary Angioedema is a genetic condition characterised by swelling of tissues. These swellings can occur on any part of the body.
    L'angioedema ereditario è una condizione genetica caratterizzata da gonfiore dei tessuti. Questi gonfiori possono verificarsi in qualsiasi parte del corpo.
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080956
    E.1.2Term Hereditary angioedema type I
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10080960
    E.1.2Term Hereditary angioedema type II
    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 demonstrate the clinical efficacy of prophylactic treatment with KVD824 compared with placebo in preventing hereditary angioedema (HAE) attacks.
    Dimostrare l’efficacia clinica del trattamento profilattico con KVD824 rispetto al placebo nella prevenzione degli attacchi di angioedema ereditario (AE).
    E.2.2Secondary objectives of the trial
    To further characterize the clinical efficacy of KVD824.
    To investigate the safety and tolerability of KVD824.
    Caratterizzare ulteriormente l’efficacia clinica di KVD824.
    Studiare la sicurezza e la tollerabilità di KVD824.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female subjects 18 years of age and older.
    2) Confirmed diagnosis of HAE type I or II at any time in the medical history.
    3) Subject has access to and ability to use conventional treatment for HAE attacks.
    4) Subject is willing to cease any current medications being taken for
    HAE prophylaxis and Investigator determines that doing so would not place the subject at any undue safety risk.
    5) Subject's last dose of attenuated androgens was at least 28 days prior to randomization.
    6) During the Run-in Period subject meets one of the following criteria:
    a) Two Investigator-confirmed attacks in the first 4-week period.
    b) Three Investigator-confirmed attacks in =8 weeks.
    7) Subjects who are fertile and heterosexually active must adhere to
    contraception requirements throughout the trial as follows:
    a) Female subjects must agree to use at least one highly effective
    contraception method from the Screening Visit until the end of the
    contraception method from the Screening Visit until the end of the trial.
    Highly effective methods of contraception include:
    i) Progestogen-only hormonal contraception associated with inhibition of 1) Male or female subjects 18 years of age and older.
    ovulation: oral/injectable/implantable (hormonal contraception that
    contains estrogen including ethinylestradiol is excluded per Exclusion
    contains estrogen including ethinylestradiol is excluded per Exclusion 4).
    ii) Intrauterine device (IUD).
    iii) Intrauterine hormone–releasing system (IUS).
    iv) Bilateral tubal occlusion.
    v) Vasectomized partner (provided that the partner is the sole sexual partner of the female subject of childbearing potential and that the success).
    b) Male subjects with a female partner of childbearing potential must agree to use condoms for the entire Treatment Period AND for 90 day agree to use condoms for the entire Treatment Period AND for 90 days following the final dose of investigational medicinal product (IMP). Female partners are encouraged to use contraception as outlined in Female partners are encouraged to use contraception as outlined in Inclusion 7a) from the Screening Visit until the end of the trial.
    Hormonal contraception that contains estrogen including ethinylestradiol is acceptable for the female partner.
    8) Subjects who are not fertile or not sexually active, as defined below, do not require contraception.
    a) Subjects who refrain from heterosexual intercourse during the trial if the reliability of the heterosexual abstinence has been evaluated in relation to the duration of the clinical trial and is the preferred and relation to the duration of the clinical trial and is the preferred and usual lifestyle of the subject.
    b) Male subjects who are surgically sterile (e.g. vasectomized with medical assessment of surgical success).
    c) Female subjects who are surgically sterile (e.g. status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months.
    1) Soggetti di sesso maschile o femminile di età pari e superiore a 18 anni.
    2) Diagnosi confermata di AE di tipo I o II in qualsiasi momento nell’anamnesi medica.
    3) Il soggetto ha accesso e capacità di utilizzare il trattamento convenzionale per gli attacchi di AE.
    4) Il soggetto è disposto a interrompere qualsiasi farmaco attualmente assunto per la profilassi dell’AE e lo sperimentatore stabilisce che ciò non esporrebbe il soggetto ad alcun rischio ingiustificato per la sicurezza.
    5) L’ultima dose di androgeni attenuati somministrata al soggetto risaliva ad almeno 28 giorni prima della randomizzazione.
    6) Durante il periodo di run-in, il soggetto soddisfa uno dei seguenti criteri:
    a) Due attacchi confermati dallo sperimentatore nel primo periodo di 4 settimane.
    b) Tre attacchi confermati dallo sperimentatore in = 8 settimane.
    7) I soggetti fertili ed eterosessualmente attivi devono rispettare i requisiti contraccettivi per tutta la durata della sperimentazione, come segue:
    a) I soggetti di sesso femminile devono acconsentire a utilizzare almeno un metodo contraccettivo altamente efficace dalla visita di screening fino alla fine della sperimentazione. I metodi contraccettivi altamente efficaci includono:
    i) Contraccezione ormonale solo progestinica associata all’inibizione dell’ovulazione: orale/iniettabile/impiantabile (la contraccezione ormonale che contiene estrogeni, compreso etinilestradiolo, è esclusa in base al criterio di esclusione 4).
    ii) Dispositivo intrauterino (Intrauterine Device, [IUD]).
    iii) Sistema intrauterino a rilascio di ormoni (Intrauterine system, [IUS]).
    iv) Occlusione tubarica bilaterale.
    v) Partner vasectomizzato (a condizione che sia l’unico partner sessuale del soggetto di sesso femminile potenzialmente fertile e che il partner vasectomizzato abbia ricevuto la valutazione medica di successo dell’intervento chirurgico).
    b) I soggetti di sesso maschile con una partner di sesso femminile in età fertile devono acconsentire a utilizzare il preservativo per l’intero periodo di trattamento E per 90 giorni dopo l’assunzione della dose finale del medicinale sperimentale (Investigational Medicinal Product, [IMP]). Le partner di sesso femminile sono esortate a utilizzare metodi contraccettivi come indicato nel criterio di inclusione 7a) dalla visita di screening fino alla fine della sperimentazione. Metodi di contraccezione ormonale che contengono estrogeni, compreso etinilestradiolo, sono accettabili per la partner di sesso femminile.
    8) I soggetti che non sono fertili o non sono sessualmente attivi, come definito di seguito, non necessitano di contraccezione.
    a) Soggetti che si astengono dai rapporti eterosessuali durante la sperimentazione, se l’affidabilità dell’astinenza eterosessuale è stata valutata in relazione alla durata della sperimentazione clinica e costituisce lo stile di vita preferito e abituale del soggetto.
    b) Soggetti di sesso maschile chirurgicamente sterili (per es., vasectomizzati con valutazione medica di successo chirurgico).
    c) Soggetti di sesso femminile chirurgicamente sterili (per es. stato post-isterectomia, ovariectomia bilaterale o legatura bilaterale delle tube) o in post-menopausa da almeno 12 mesi.
    E.4Principal exclusion criteria
    1) Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (previously known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
    2) A clinically significant history of poor response to C1-INH therapy or plasma kallikrein inhibitor therapy, for the management of HAE, in the opinion of the Investigator.
    3) Use of angiotensin-converting enzyme (ACE) inhibitors after the Screening Visit or within 7 days prior to randomization.
    4) Any estrogen containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) after the Screening Visit or within 7 days prior to randomization.
    5) Use of narrow therapeutic index drugs metabolized by CYP3A4 or CYP2C9 or transported by OAT1, OCT2, and OATP1B1 starting at screening, as determined by the Investigator.
    6) Use of strong CYP3A4 inhibitors and inducers during participation in the trial, starting at the Screening Visit. Note: These medications include but are not limited to the following: Inhibitors: boceprevir, clarithromycin, cobicistat, dasabuvir, denoprevir, elvitegravir, idelalisib, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ombitasvir, paritaprevir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, tipranavir, troleandomycin, and voriconazole. Inducers:
    apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's Wort.
    7) Inadequate organ function including but not limited to:
    a) Alanine aminotransferase (ALT) > 2x ULN.
    b) Aspartate aminotransferase (AST) > 2x ULN.
    c) Bilirubin direct > 1.25x ULN
    d) International normalized ratio (INR) > 1.2.
    e) Clinically significant hepatic impairment defined as a Child-Pugh B or C.
    f) Estimated glomerular filtration rate (eGFR) <60 mL/min.
    8) Any clinically significant comorbidity or systemic dysfunction that, in the opinion of the Investigator, would jeopardize the safety of the subject by participating in the trial.
    9) History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
    10) Known hypersensitivity to KVD824 or placebo or to any of the excipients.
    11) Any prior use of any gene therapy treatment for HAE.
    12) Participation in any interventional investigational clinical trial within 4 weeks of the last dosing of investigational drug prior to screening.
    13) Any pregnant or breastfeeding subject.
    1) Qualsiasi diagnosi concomitante di un’altra forma di angioedema cronico, come deficit acquisito di inibitore di C1, AE con C1-INH normale (precedentemente noto come AE di tipo III), angioedema idiopatico o angioedema associato a orticaria.
    2) Un’anamnesi clinicamente significativa di scarsa risposta alla terapia con C1-INH o alla terapia con inibitore della callicreina plasmatica per la gestione dell’AE, secondo il parere dello sperimentatore.
    3) Uso di inibitori dell’enzima di conversione dell’angiotensina (ACE) dopo la visita di screening o nei 7 giorni precedenti la randomizzazione.
    4) Qualsiasi farmaco contenente estrogeni con assorbimento sistemico (come contraccettivi orali, tra cui etinilestradiolo o terapia ormonale sostitutiva) dopo la visita di screening o nei 7 giorni precedenti la randomizzazione.
    5) Uso di farmaci con indice terapeutico ristretto, metabolizzati dal CYP3A4 o CYP2C9 o trasportati da OAT1, OCT2 e OATP1B1, a partire dallo screening e in base alla valutazione dello sperimentatore.
    6) Uso di forti inibitori e induttori del CYP3A4 durante la partecipazione alla sperimentazione, a partire dalla visita di screening. Nota: Tali farmaci comprendono, a titolo esemplificativo ma non esaustivo, quanto segue: Inibitori: boceprevir, claritromicina, cobicistat, dasabuvir, denoprevir, elvitegravir, idelalisib, indinavir, itraconazolo, ketoconazolo, lopinavir, nefazodone, nelfinavir, ombitasvir, paritaprevir, posaconazolo, ritonavir, saquinavir, telaprevir, telitromicina, tiptaprevir, troleandomicina e voriconazolo. Induttori: apalutamide, carbamazepina, enzalutamide, mitotano, fenitoina, rifampicina, iperico.
    7) Funzione d’organo inadeguata, tra cui, a titolo esemplificativo ma non esaustivo:
    a) Alanina aminotransferasi (ALT) > 2x ULN.
    b) Aspartato aminotransferasi (AST) > 2x ULN.
    c) Bilirubina diretta > 1,25x ULN.
    d) Rapporto normalizzato internazionale (International Normalized Ratio, [INR]) > 1,2.
    e) Insufficienza epatica clinicamente significativa, definita come un test Child-Pugh B o C.
    f) Velocità di filtrazione glomerulare stimata (eGFR) < 60 ml/min.
    8) Qualsiasi comorbilità o disfunzione sistemica clinicamente significativa che, a giudizio dello sperimentatore, comprometterebbe la sicurezza del soggetto se partecipasse alla sperimentazione.
    9) Anamnesi di abuso di o dipendenza da sostanze che, secondo quanto stabilito dallo sperimentatore, interferirebbero con il completamento della sperimentazione.
    10) Ipersensibilità nota a KVD824 o al placebo o a uno qualsiasi degli eccipienti.
    11) Qualsiasi uso precedente di qualsiasi trattamento di terapia genica per AE.
    12) Partecipazione a qualsiasi studio clinico interventistico sperimentale entro 4 settimane dall’ultima somministrazione del farmaco sperimentale prima dello screening.
    13) Soggetto in gravidanza o allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this trial is the rate of Investigator-confirmed HAE attacks during the Treatment Period.
    L’endpoint primario di questa sperimentazione è il tasso di attacchi di AE confermati dallo sperimentatore durante il periodo di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    • Proportion of subjects without Investigator-confirmed HAE attacks during the Treatment Period.
    • Rate of Investigator-confirmed HAE attacks that require conventional treatment during the Treatment Period.
    • Angioedema Quality of Life Questionnaire (AE-QoL) total score and domain scores during the Treatment Period.
    • Angioedema Control Test (AECT) score and domain scores during the Treatment Period.
    • Proportion of subjects with an AECT score > =12 at the end of the Treatment Period.
    • Percentuale di soggetti che non manifestano attacchi di AE confermati dallo sperimentatore durante il periodo di trattamento.
    • Tasso di attacchi di AE confermati dallo sperimentatore che richiedono un trattamento convenzionale durante il periodo di trattamento.
    • Punteggio totale del questionario per misurare la qualità della vita nell’angioedema (AE-QoL) e punteggi di dominio durante il periodo di trattamento.
    • Punteggio del test di controllo dell’angioedema (AECT) e punteggi di dominio durante il periodo di trattamento.
    • Percentuale di soggetti con un punteggio AECT > = 12 alla fine del periodo di trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 EEA15
    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
    Australia
    Canada
    North Macedonia
    New Zealand
    United States
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Romania
    United Kingdom
    Czechia
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 20
    F.4.2.2In the whole clinical trial 48
    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 Decision2021-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-09-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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