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    Summary
    EudraCT Number:2022-002395-36
    Sponsor's Protocol Code Number:P-SP420-THAL-01
    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:2022-12-21
    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 number2022-002395-36
    A.3Full title of the trial
    An open-label, dose-escalation, dose-finding, and proof-of-concept trial of SP-420 in subjects with transfusion-dependent ß-thalassemia
    Sperimentazione proof-of-concept in aperto, con incremento progressivo della dose, per la determinazione del dosaggio di SP-420 in soggetti con beta talassemia trasfusione-dipendente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of open administration of a drug, which removes iron from the body of patients with transfusion-dependent ß-thalassemia, aiming to find the most appropriate dose through use of different dose levels in different patients
    Studio sulla somministrazione in aperto di un farmaco che rimuove il ferro dall’organismo di pazienti con beta talassemia trasfusione dipendente, con l’obiettivo di trovare la dose appropriata mediante l’utilizzo di diversi livelli di dose in diversi pazienti.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberP-SP420-THAL-01
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1277-5903
    A.5.4Other Identifiers
    Name:INDNumber:119889
    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 SponsorPharmacosmos A/S
    B.1.3.4CountryDenmark
    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 supportPharmacosmos A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacosmos A/S
    B.5.2Functional name of contact pointMartin Damm Olling
    B.5.3 Address:
    B.5.3.1Street AddressRoervangsvej 30
    B.5.3.2Town/ cityHolbaek
    B.5.3.3Post codeDK 4300
    B.5.3.4CountryDenmark
    B.5.6E-mailinfo@pharmacosmos.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 nameSP-420
    D.3.2Product code [SP-420]
    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 INNNon ancora assegnato
    D.3.9.1CAS number 911714-45-9
    D.3.9.2Current sponsor codeSP-420
    D.3.9.3Other descriptive name(S)-4,5-dihydro-2-[2-hydroxy-4-(3,6-dioxaheptyloxy)phenyl]-4-methyl-4thiazolecarboxylic acid
    D.3.9.4EV Substance CodeSUB292278
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Transfusion-dependent ß-thalassemia
    Beta talassemia trasfusione-dipendente
    E.1.1.1Medical condition in easily understood language
    Beta-thalassemia is a rare disease that is inherited and leads to a reduced production of hemoglobin (anemia).
    La beta talassemia è una malattia rara ed ereditaria e porta a una ridotta produzione di emoglobina (anemia).
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10054660
    E.1.2Term Thalassemia beta
    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
    Primary efficacy objective
    To establish dose-response relationship of SP-420 for 24 weeks in the treatment of subjects with transfusion-dependent ß-thalassemia
    Obiettivo di efficacia primario
    Stabilire la relazione dose-risposta di SP-420 per 24 settimane nel trattamento di soggetti con beta talassemia trasfusione-dipendente
    E.2.2Secondary objectives of the trial
    Key-secondary efficacy objective
    To assess the efficacy of SP-420 in clearing iron from the liver after 24 weeks treatment of subjects with transfusion-dependent ß-thalassemia
    Secondary efficacy objective
    To assess the efficacy of SP-420 in clearing iron from the liver after 12 and 48 weeks treatment of subjects with transfusion-dependent ß-thalassemia
    To assess the efficacy of SP-420 in total body iron removal after 12 and 48 weeks treatment of subjects with transfusion-dependent ß-thalassemia
    To assess the efficacy of SP-420 on serum (s-) ferritin
    Secondary safety objective
    To assess the safety and tolerability of ascending doses of SP-420


    Obiettivo di efficacia secondario chiave
    Valutare l’efficacia di SP-420 nell’eliminare il ferro dal fegato dopo 24 settimane di trattamento in soggetti con beta talassemia trasfusione-dipendente
    Obiettivi di efficacia secondari
    Valutare l’efficacia di SP-420 nell’eliminare il ferro dal fegato dopo 12 e 48 settimane di trattamento in soggetti con beta talassemia trasfusione-dipendente
    Valutare l’efficacia di SP-420 nel rimuovere il ferro corporeo totale dopo 12 e 48 settimane di trattamento in soggetti con beta talassemia trasfusione-dipendente
    Valutare l’efficacia di SP-420 sulla ferritina sierica (s-ferritina)
    Obiettivo di sicurezza secondario
    Valutare la sicurezza e la tollerabilità delle dosi ascendenti di SP-420
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women and men aged >=18 years
    2. Transfusion-dependent ß-thalassemia including HbE/ß-thalassemia requiring iron chelation therapy (ß-thalassemia with mutation and/or multiplication of alfa-globin is allowed)
    3. On a stable dose of iron chelation for at least 4 weeks prior to screening
    4. Weight >=35 kg at screening
    5. Willing to discontinue current iron chelation therapy 7 days (± 3 days) prior to the first dose of SP-420 and for the duration of the trial
    6. Transfusion iron overload defined as LIC >=5 and <=20 mg/g dw on the R2-MRI obtained within 2 weeks prior to baseline
    7. Subject has been treated and followed for at least the past 6 months in a specialised centre that maintained detailed medical records, including transfusion and iron chelation histories
    8. Willingness to participate and signing the informed consent form.
    1. Donne e uomini di età >=18 anni
    2. Beta talassemia trasfusione-dipendente inclusa HbE/beta talassemia che richiede una terapia ferrochelante (la beta talassemia con mutazione e/o moltiplicazione di alfa-globina è consentita)
    3. Assume una dose stabile di ferrochelanti da almeno 4 settimane prima dello screening
    4. Peso >=35 kg allo screening
    5. Disposto a interrompere l’attuale terapia ferrochelante 7 giorni (±3 giorni) prima della prima somministrazione di SP-420 e per l’intera durata della sperimentazione
    6. Sovraccarico di ferro da trasfusione definito come LIC >=5 e <=20 mg/g dw in base alla RMI R2 ottenuta entro 2 settimane dal basale
    7. Il soggetto è stato trattato e seguito per almeno gli ultimi 6 mesi in un centro specializzato che ha conservato cartelle cliniche dettagliate, incluse le anamnesi delle trasfusioni e delle terapie ferrochelanti
    8. Disposto a partecipare e firmare il modulo di consenso informato.
    E.4Principal exclusion criteria
    1. ß-thalassemia with the structural Hb variants HbS and HbC
    2. Cardiac MRI-T2 score <10 msec obtained within 2 weeks prior to baseline
    3. S-ferritin <500 or >4000 ng/mL
    4. Current malignancy with the exceptions of localised basal cell or squamous cell skin cancer or localised prostate cancer or is receiving immunotherapy, chemotherapy, or radiation therapy for a malignancy
    5. Current myelodysplastic syndrome
    6. Current biliary disorder
    7. ALAT >4 times the upper limit of normal, decompensated cirrhosis, or ascites at screening
    8. Past or ongoing history of clinically significant kidney disease
    9. Creatinine greater than the upper limit of normal at screening
    10. Estimated glomerular filtration rate eGFR <60 mL/min/1.73 m2
    11. Urine protein to creatinine ratio >0.5 mg/mg at screening
    12. Heart failure grade II, III and IV by NYHA
    13. Left ventricular ejection fraction (LVEF) on MRI <56 % (echocardiography allowed if MRI not available)
    14. A QTcF >450 ms, 2nd or 3rd degree atrioventricular block, or incomplete left hemiblock, or the presence of clinically significant abnormalities as determined by the Investigator at screening
    15. Hypertransfused defined as more than 6 units/month in average for the last 6 months prior to screening
    16. Ongoing symptoms of neuropathy, including peripheral sensory neuropathy, peripheral motor neuropathy, or paresthesia at screening
    17. Platelet count <100×109/L at screening
    18. History of hypersensitivity to an iron chelator (investigational or marketed) or excipients
    19. Documented history of non-compliance to chelation therapy within past 2 years
    20. Received another investigational drug within 30 days or investigational antibody within 90 days before screening
    21. Treatment with prohibited medication: iron, aluminium containing antacid therapies, systemic corticosteroids (topical and pulmonary corticosteroids are allowed), oral bisphosphonates, chronic use of high dose NSAIDs (as needed and low dose acetylsalicylic acid are allowed), drugs with known renal toxicity, drugs with known QTc prolongation, potent UGT inducers (e.g. rifampicin, phenytoin, phenobarbital, ritonavir) within 7 days prior to baseline
    22. Initiation of treatment with luspatercept within 6 months prior to screening (luspatercept is allowed if initiated and dose is stable at least 6 months prior to screening)
    23. Subject unable to undergo trial assessments including MRI, e.g. who are claustrophobic to MRI, have a cardiac pacemaker, ferromagnetic metal implants other than those approved as safe for use in MR scanners (e.g. some types of aneurysm clips, and shrapnel), and subjects who are obese (exceeding the equipment limits)
    24. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing potential (premenopausal and not surgically sterile) have to use highly efficient contraception (e.g. intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)) during the whole trial period and 4 weeks post-dosing. A sterile sole partner or sexual abstinence is also considered acceptable provided it reflects the usual and preferred lifestyle of the participant
    25. Men, even if surgically sterilised, (i.e. status post vasectomy), who do not agree to practice effective barrier contraception during the entire trial period, or agrees to completely abstain from heterosexual intercourse
    26. Any other laboratory abnormality, medical condition, or psychiatric disorder which, in the opinion of the Investigator, will put the subject’s disease management at risk or may result in the subject being unable to comply with the trial requirements
    1. Beta talassemia con le varianti strutturali dell’emoglobina, HbS e HbC
    2. Punteggio RMI T2* cardiaca <10 msec ottenuta entro 2 settimane prima del basale
    3. s-ferritina <500 oppure >4000 ng/ml
    4. Attuale neoplasia maligna a eccezione del carcinoma cutaneo localizzato basocellulare o squamoso oppure cancro della prostata localizzato, oppure in trattamento con immunoterapia, chemioterapia o radioterapia per una neoplasia maligna
    5. Attuale sindrome mielodisplastica
    6. Attuale disturbo biliare
    7. Alanina aminotransferasi (ALAT) >4 volte il limite superiore della norma, cirrosi scompensata o ascite allo screening
    8. Anamnesi pregressa o in atto di malattia renale clinicamente significativa
    9. Creatinina superiore al limite superiore della norma allo screening
    10. Velocità di filtrazione glomerulare stimata eGFR <60 ml/min/1,73 m2
    11. Rapporto tra proteinuria e creatinina >0,5 mg/mg allo screening
    12. Insufficienza cardiaca di grado II, III e IV secondo la New York Heart Association (NYHA)
    13. Ffrazione di eiezione ventricolare sinistra (FEVS) alla RMI <56% (l’ecocardiografia è permessa se la RMI non è disponibile)
    14. QTcF >450 msec, blocco atrioventricolare di secondo o terzo grado, o emiblocco sinistro incompleto, oppure presenza di anomalie clinicamente significative determinate dallo Sperimentatore allo screenin;
    15. Ipertrasfuso, definito come oltre 6 unità/mese in media per almeno 6 mesi prima dello screening
    16. Sintomi in atto di neuropatia, inclusa la neuropatia sensitiva periferica, neuropatia motoria periferica o parestesia allo screening
    17. conta piastrinica <100×109/l allo screening
    18. Anamnesi di ipersensibilità a un ferrochelante (sperimentale o in commercio) o a eccipienti
    19. Anamnesi documentata di mancata aderenza alla terapia di chelazione nei 2 anni precedenti
    20. Assunzione di un altro farmaco sperimentale nei 30 giorni o anticorpo sperimentale nei 90 giorni precedenti lo screening
    21. Trattamento con farmaci proibiti: ferro, terapie con antiacidi a base di alluminio, corticosteroidi sistemici (sono consentiti i corticosteroidi polmonari e topici), bifosfonati orali, uso cronico di farmaci antinfiammatori non steroidei (FANS) ad alto dosaggio (è consentito l’acido acetilsalicilico a basso dosaggio al bisogno), farmaci con tossicità renale nota, farmaci con allungamento del QTc noto, potenti induttori dell’uridina-5-difosfato glucuronosiltransferasi (UGT) (ad es. rifampicina, fenitoina, fenobarbital, ritonavir) nei 7 giorni precedenti il basale
    22. Avvio di un trattamento con luspatercept nei 6 mesi precedenti lo screening (luspatercept è consentito se iniziato e a dose stabile da almeno 6 mesi prima dello screening)
    23. Soggetto non in grado di sottoporsi alle valutazioni della sperimentazione inclusa la RMI, ad es. se soffre di claustrofobia nell’eseguire la RMI, se ha un pacemaker cardiaco, impianti in metallo ferromagnetico diversi da quelli approvati come sicuri per l’uso negli scanner della risonanza magnetica (RM) (ad es. alcuni tipi di clip per aneurismi e frammenti di proiettile), nonché se è un soggetto obeso (che eccede i limiti dell’apparecchiatura)
    24. donna in stato di gravidanza o che allatta con latte materno. Al fine di evitare una gravidanza, le donne in età fertile (in premenopausa e non chirurgicamente sterili) devono usare un metodo contraccettivo altamente efficace (ad es. dispositivi intrauterini, contraccettivi ormonali [pillola contraccettiva, impianti, cerotti transdermici, dispositivi vaginali o iniezioni ormonali a rilascio prolungato]) durante l’intero periodo della sperimentazione e per 4 settimane dopo la somministrazione. Un unico partner sterile o l’astinenza sessuale sono considerati accettabili, purché rispecchino lo stile di vita abituale e preferito della partecipante
    25. uomo, sebbene chirurgicamente sterilizzato (ossia in stato di post-vasectomia), che non acconsente a usare un metodo contraccettivo di barriera efficace durante l’intero periodo della sperimentazione, o che acconsente ad astenersi completamente dai rapporti sessuali eterosessuali
    26. qualsiasi altra anomalia di laboratorio, condizione medica o disturbo psichiatrico che, a giudizio dello Sperimentatore, metterebbe a rischio la gestione della malattia del soggetto o che potrebbe comportare l’impossibilità da parte del paziente di attenersi ai requisiti della sperimentazione.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    • Total body iron removed by SP-420 from baseline to week 24
    Endpoint di efficacia primario
    • Ferro corporeo totale rimosso da SP-420 dal basale alla settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to protocol
    Si prega di far riferimento al protocollo
    E.5.2Secondary end point(s)
    Key-secondary efficacy endpoints
    • Change in liver iron concentration (LIC) measured by R2-magnetic resonance imaging (MRI) from baseline to week 24
    Secondary efficacy endpoints
    • Change in LIC measured by R2-MRI from baseline to week 12 and week 48
    • Total body iron removed by SP-420 from baseline to week 12 and week 48, and from week 24 to week 48
    • Change in s-ferritin from baseline to weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
    Secondary safety endpoints
    • Type and incidence of adverse events (AEs)
    Endpoint di efficacia secondario chiave
    • Variazione della concentrazione di ferro nel fegato (LIC) misurata mediante risonanza magnetica per immagini (RMI) R2 dal basale alla settimana 24
    Endpoint di efficacia secondari
    • Variazione della LIC misurata da RMI R2 dal basale alla settimana 12 e alla settimana 48
    • Ferro corporeo totale rimosso da SP-420 dal basale alla settimana 12 e alla settimana 48, e dalla settimana 24 alla settimana 48
    • Variazione della s-ferritina dal basale alle settimane 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 e 48
    Endpoint di sicurezza secondario
    • Tipo e incidenza degli eventi avversi (AE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol
    Si prega di far riferimento al protocollo
    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 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 Yes
    E.6.13.1Other scope of the trial description
    dose-escalation, dose-finding, and proof-of-concept
    Incremento progressivo della dose, determinazione del dosaggio e proof-of-concept
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    In aperto
    Open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Lebanon
    Oman
    Qatar
    Thailand
    United Arab Emirates
    Greece
    Italy
    Denmark
    Turkey
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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.1.1.1In 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: 90
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
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