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    Summary
    EudraCT Number:2022-000875-37
    Sponsor's Protocol Code Number:VanC-IT
    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:2022-08-26
    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 number2022-000875-37
    A.3Full title of the trial
    A Prospective, Randomized, Placebo-controlled Clinical Trial of oral vancomycin in adults and young adults (15-17 years old) affected by Primary Sclerosing Cholangitis with or without Inflammatory Bowel Disease
    Studio clinico prospettico, randomizzato, controllato con placebo sulla vancomicina orale in adulti e giovani adulti (15-17 anni) affetti da colangite sclerosante primitiva con o senza malattia infiammatoria intestinale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in adults and young patients with Primary Sclerosing Cholangitis treated with oral vancomycin or placebo
    Studio clinico in adulti e giovani affetti da Colangite Sclerosante Primitiva trattati con Vancomicina ad uso orale o placebo
    A.3.2Name or abbreviated title of the trial where available
    Vancomycin in Primary Sclerosing Cholangitis in Italy
    Vancomicina nella Colangite Sclerosante Primitiva in Italia
    A.4.1Sponsor's protocol code numberVanC-IT
    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 SponsorUNIVERSITÀ DEGLI STUDI MILANO BICOCCA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGenetic s.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità Milano-Bicocca
    B.5.2Functional name of contact pointUfficio BiCRO (Bicocca Clinical Res
    B.5.3 Address:
    B.5.3.1Street Addressvia Pergolesi, 33
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number0264488155
    B.5.6E-mailbicro@unimib.it
    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 Yes
    D.2.1.1.1Trade name LEVOVANOX
    D.2.1.1.2Name of the Marketing Authorisation holderGENETIC 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.3.1Product nameLEVOVANOX
    D.3.2Product code [LEVOVANOX]
    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 INNVANCOMICINA CLORIDRATO
    D.3.9.2Current sponsor codeVANCOMICINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Sclerosing Cholangitis
    Colangite Sclerosante Primitiva
    E.1.1.1Medical condition in easily understood language
    Chronic autoimmune pathology of the liver with alteration of the biliary tract
    Patologia cronica autoimmune del fegato con alterazione delle vie biliari
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036732
    E.1.2Term Primary sclerosing cholangitis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of OV at different doses versus placebo on alkaline phosphatase (ALP) at 6 months.
    Comparare l’effetto di due diversi dosaggi di Vancomicina ad uso orale e del trattamento placebo sui livelli di ALP, dopo sei mesi di trattamento, in soggetti adulti e giovani affetti da Colangite Sclerosante Primitiva
    E.2.2Secondary objectives of the trial
    - To determine the safety and tolerability of OV in each treatment arm;
    - To evaluate the effect of OV at different doses versus placebo at 6 months on the following:
    • liver fibrosis assessed by liver stiffness measurements (LSM) using transient elastography (TE)
    • magnetic resonance cholangiopancreatography (MRCP) traditional semiquantitative scoring (Amsterdam criteria/Anali criteria) and continuous scoring using MRCP+ & Liver multiscan technology (Perspectum Diagnostics Ltd)
    • non-invasive biomarkers of liver fibrosis (ELF, PRO-C3, PRO-C5; C3M, C4M and BGM), cell apoptosis and necrosis (CK18 M30 and M65), cytokines (TGF-ß, IL-4, IL-13, IL-10, etc.) peripheral blood mononuclear cells (Th1 and Th17 subsets), and biomarkers of farnesoid-X-receptor (FXR) activity (FGF-19, C4 and bile acid)
    • clinical, endoscopic and histologic activity of IBD
    • quality of life
    - Determinare la sicurezza e la tollerabilità di OV in ciascun braccio di trattamento;
    - Valutare l'effetto di due diversi dosaggi di OV e del trattamento placebo a 6 mesi su quanto segue:
    • fibrosi epatica valutata mediante misurazioni della rigidità epatica (LSM) e mediante elastografia transitoria (TE)
    • Colangiopancreatografia a risonanza magnetica (MRCP) con punteggio semiquantitativo tradizionale (criteri Amsterdam/criteri Anali) e con punteggio continuo utilizzando la tecnologia MRCP+ e multiscan del fegato (Perspectum Diagnostics Ltd)
    • biomarcatori non invasivi di fibrosi epatica (ELF, PRO-C3, PRO-C5; C3M, C4M e BGM), apoptosi e necrosi cellulare (CK18 M30 e M65), citochine (TGF-ß, IL-4, IL-13 , IL-10, ecc.) cellule mononucleate del sangue periferico (sottoinsiemi Th1 e Th17) e biomarcatori dell'attività del recettore X del farnesoide (FXR) (FGF-19, C4 e acido biliare)
    • attività clinica, endoscopica e istologica delle IBD
    • qualità della vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to give informed consent prior to any study specific procedure being performed;
    2. Male and non-pregnant, non-lactating female subjects, including women of child bearing potential (WOCBP), between 15-70 years of age at the time of informed consent;
    3. Diagnosis of large-duct PSC based on cholangiogram (at MRCP, Endoscopic retrograde cholangiopancreatography [ERCP], percutaneous transhepatic cholangiography [PTC]) according to the most recent published guidelines (EASL);
    4. Baseline ALP =1.5 times upper limit normal at screening;
    5. Absence of biliary obstruction and/or malignancy within 6-12 months of entry into the study;
    6. If a patient is on ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid he or she is expected to remain on the same daily dose during the study period;
    7. Patients who received antibiotics or probiotics may participate if they had a washout period of at least 3-month prior to study entry;
    8. If a patient has been on obeticholic acid or other experimental therapies (e.g. cilofexor and norUDCA) for PSC, they must complete a 3-month washout period before study entry;
    9. PSC with or without IBD. IBD diagnosis should be documented and with a minimum disease duration of 6 months, as determined by endoscopic and histopathology assessment. IBD should be in clinical remission or mildly active according to CDAI and partial Mayo score for CD and UC, respectively (i.e. patients with CDAI score < 220 and pMayo score <5). Patients without documented IBD need a colonoscopy with segmental biopsies within 12 months prior to baseline visit;
    10. Female subjects of childbearing potential must test negative for pregnancy at screening, baseline and follow-up visits and if engage in sexual intercourse must agree to use specific methods of contraception.
    1. Disposti e in grado di fornire il consenso informato prima dell'esecuzione di qualsiasi procedura specifica dello studio;
    2. Soggetti maschi, e femmine non gravide e non in allattamento, comprese le donne in età fertile (WOCBP), di età compresa tra 15 e 70 anni al momento del consenso informato;
    3. Diagnosi di PSC dei grandi dotti basata su colangiogramma (alla MRCP, colangiopancreatografia endoscopica retrograda [ERCP], colangiografia percutanea transepatica [PTC]) secondo le più recenti linee guida pubblicate (EASL);
    4. ALP basale =1,5 volte il limite superiore normale allo screening;
    5. Assenza di ostruzione biliare e/o malignità entro 6-12 mesi dall'ingresso nello studio;
    6. Se un paziente è in trattamento con acido ursodesossicolico (UDCA) o acido 5-aminosalicilico si prevede che mantenga la stessa dose giornaliera durante il periodo di studio;
    7. Possono partecipare i pazienti che hanno ricevuto antibiotici o probiotici se hanno avuto un periodo di washout di almeno 3 mesi prima dell'ingresso nello studio;
    8. Se un paziente è stato in trattamento con acido obeticolico o altre terapie sperimentali (es. cilofexor e norUDCA) per PSC, deve completare un periodo di washout di 3 mesi prima dell'ingresso nello studio;
    9. PSC con o senza IBD. La diagnosi di IBD deve essere documentata e con una durata minima della malattia di 6 mesi, come determinato dalla valutazione endoscopica e istopatologica. L'IBD dovrebbe essere in remissione clinica o leggermente attiva secondo CDAI e punteggio Mayo parziale per CD e CU, rispettivamente (cioè pazienti con punteggio CDAI < 220 e punteggio pMayo <5). I pazienti senza IBD documentata necessitano di una colonscopia con biopsie segmentali entro 12 mesi dalla visita di base;
    10. I soggetti di sesso femminile in età fertile devono risultare negativi alla gravidanza nelle visite di screening, e di trattamento; se hanno rapporti sessuali devono accettare di utilizzare metodi contraccettivi specifici.
    E.4Principal exclusion criteria
    1. Receiving an antibiotic or probiotic within 3 months prior to the study;
    2. Expected to receive antibiotics within the weeks leading up to enrollment (such as patients with recurrent cholangitis, ongoing infectious illnesses, etc.) ;
    3. Allergy to vancomycin or teicoplanin;
    4. Biliary intervention within 3 months prior to study enrollment or planned;
    5. Alcohol abuse (defined as greater than 14 standard drinks units per week in men; greater than 7 standard drinks units per week);
    6. Pregnancy and lactation;
    7. Advanced renal disease (glomerular filtration rate [GFR ]< 70);
    8. Active hepatitis B and/or C infection;
    9. Other chronic or cholestatic liver diseases such as primary biliary cholangitis (PBC), autoimmune hepatitis, nonalcoholic steatohepatitis, alcoholic liver disease, Wilson’s disease, hemochromatosis, a-1 antitrypsin deficiency, IgG4-related sclerosing cholangitis, and liver cancer;
    10. History of cholangiocarcinoma [CCA];
    11. Advanced liver disease (history of variceal bleeding, ascites, hepatic encephalopathy, and/or bilirubine >4 mg/dL) ;
    12. On active transplantation list;
    13. IBD with uncontrolled moderate to severe activity;
    14. Treatment with any immunosuppressive medication for controlling IBD (i.e. azathioprine, 6-mercaptopurine, tacrolimus, methotrexate, infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod). Treatment with corticosteroids (including budesonide, budesonide MMX and beclomethasone) in the previous four weeks;
    15. Treatment with rifampicin;
    16. Dose change within last 3 months prior to baseline of concomitant treatment with vitamin D or fibrates;
    17. Treatment with any experimental drug within the previous three months;
    18. Any known relevant infectious disease (e.g. active tuberculosis, AIDS defining disease);
    19. Any active malignant disease;
    20. Well found doubt about patient’s cooperation, e.g. addiction to alcohol or drugs;
    21. Imprisoned person, person admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent.
    1. Ricevere un antibiotico o un probiotico entro 3 mesi dall’inizio dello studio;
    2. Previsione di ricevere antibiotici nelle settimane precedenti l'arruolamento (come pazienti con colangite ricorrente, malattie infettive in corso, ecc.);
    3. Allergia alla vancomicina o alla teicoplanina;
    4. Intervento biliare entro 3 mesi dall’arruolamento o intervento programmato;
    5. Abuso di alcol (definito come maggiore di 14 unità di bevande standard a settimana negli uomini; maggiore di 7 unità di bevande standard a settimana);
    6. Gravidanza e allattamento;
    7. Malattia renale avanzata (velocità di filtrazione glomerulare [GFR ]< 70);
    8. Infezione attiva da epatite B e/o C;
    9. Altre malattie epatiche croniche o colestatiche come colangite biliare primitiva (CBP), epatite autoimmune, steatoepatite non alcolica, malattia epatica alcolica, morbo di Wilson, emocromatosi, deficit di a-1 antitripsina, colangite sclerosante correlata a IgG4 e cancro al fegato;
    10. Storia di colangiocarcinoma [CCA];
    11. Malattia epatica avanzata (storia di sanguinamento da varici, ascite, encefalopatia epatica e/o bilirubina >4 mg/dL)
    12. Inseriti nella lista dei trapianti;
    13. IBD con attività incontrollata da moderata a grave;
    14. Trattamento con qualsiasi farmaco immunosoppressore per il controllo delle MICI (es. azatioprina, 6-mercaptopurina, tacrolimus, metotrexato, infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod). Trattamento con corticosteroidi (inclusi budesonide, budesonide MMX e beclometasone) nelle quattro settimane precedenti;
    15. Trattamento con rifampicina;
    16. Modifica della dose del trattamento concomitante con vitamina D o fibrati negli ultimi 3 mesi prima del basale;
    17. Trattamento con qualsiasi farmaco sperimentale nei tre mesi precedenti;
    18. Qualsiasi malattia infettiva rilevante nota (ad es. tubercolosi attiva, malattia che definisce l'AIDS);
    19. Qualsiasi malattia maligna attiva;
    20. Dubbi sulla collaborazione del paziente, ad es. dipendenza da alcol o droghe;
    21. Detenuto, persona ricoverata in case di cura, persone sotto tutela legale e persone non in grado di esprimere il proprio consenso.
    E.5 End points
    E.5.1Primary end point(s)
    ALP levels at 6 months
    Livelli ALP a 6 mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    - reduction of ALP levels =40% (for those of 15-17-year-old the liver isoenzyme will be evaluated);
    - safety and tolerability: adverse events, clinical hematology, clinical chemistry, urinalysis, single 12-lead electrocardiograms (ECGs), vital sign measurements including body weight, systolic and diastolic blood pressure (BP), body temperature and pulse rate. Rectal swab to exclude infection or colonisation with vancomycin-resistant enterococci (VRE);
    - reduction of serum gammaglutamyltransferase (GGT) levels;
    - reduction of serum aspartate-aminotransferase (AST) and Alanine-aminotransferase (ALT) levels;
    - normalization of serum bilirubin levels;
    - change in Amsterdam-Oxford prognostic score;
    - change in the Revised PSC Mayo Risk Score;
    - lack of progression in LSM at FibroScan (change in liver stiffness <= 1.3 kPa);
    - lack of progression in bile duct strictures and dilatation (evaluated at MCRP using traditional semiquantitative scoring such as Amsterdam criteria and Anali criteria);
    - changes in IBD activity indexes: Crohn's Disease Activity Index [CDAI] score and partial Mayo score [pMCS], for Crohn’s disease [CD] and UC respectively; changes in C-reactive protein (CRP) and fecal calprotectin levels; changes in Simple Endoscopic Score for Crohn’s Disease [SES-CD] and endoscopic Mayo score, for CD and UC respectively; changes in Nancy Histological Index for UC and Global Histologic Disease Activity Score [GHAS] for CD;
    - proportion of patients who are in clinical remission (defined as CDAI<150 for CD or partial Mayo Score <2 for UC) at baseline, week 4, 12 and 24. and week 12 of follow up; proportion of patients achieving endoscopic remission (defined as SES-CD = 2 for CD or endoscopic Mayo score <1 for UC) at baseline and week 24; proportion of patients achieving histologic healing (as defined as GHAS =4 for CD or Nancy Histological Index <1 for UC) at baseline and week 24;
    - changes in ultrasound activity indices (length of disease, bowel wall thickness, color Doppler signals, bowel wall stratification, inflammatory mesenteric fat, and intestinal complications) at week 24;
    - changes in health-related quality of life: visual analogue scale (VAS) score for itch, Chronic Liver Disease Questionnaire (CLDQ), EQ-5D-5L questionnaire, PSC patient reported outcome (PSC-PRO) questionnaire, Inflammatory Bowel Disease Questionnaire (IBDQ).

    All the secondary endpoints will be evaluated from baseline to 6 months.
    - riduzione dei livelli di ALP =40% (per i soggetti di età 15-17 anni verrà valutato l'isoenzima epatico);
    - sicurezza e tollerabilità: eventi avversi, ematologia clinica, chimica clinica, analisi delle urine, elettrocardiogrammi a 12 derivazioni (ECG), misurazioni dei segni vitali tra cui peso corporeo, pressione arteriosa sistolica e diastolica (BP), temperatura corporea e frequenza cardiaca. Tampone rettale per escludere infezioni o colonizzazioni da enterococchi resistenti alla vancomicina (VRE);
    - riduzione dei livelli sierici di gammaglutamiltransferasi (GGT);
    - riduzione dei livelli sierici di aspartato-aminotransferasi (AST) e alanina-aminotransferasi (ALT);
    - normalizzazione dei livelli di bilirubina sierica;
    - variazione del punteggio prognostico Amsterdam-Oxford;
    - variazione del punteggio di rischio Mayo rivisto della PSC;
    - mancanza di progressione in LSM al FibroScan (variazione della rigidità epatica <= 1,3 kPa);
    - mancanza di progressione delle stenosi e della dilatazione del dotto biliare (valutata al MCRP utilizzando il tradizionale punteggio semiquantitativo come i criteri di Amsterdam e i criteri di Anali);
    - variazioni degli indici di attività delle IBD: punteggio dell'indice di attività della malattia di Crohn [CDAI] e punteggio parziale di Mayo [pMCS], rispettivamente per la malattia di Crohn [CD] e la CU; cambiamenti nella proteina C-reattiva (CRP) e nei livelli di calprotectina fecale; cambiamenti nel punteggio endoscopico semplice per la malattia di Crohn [SES-CD] e nel punteggio Mayo endoscopico, rispettivamente per CD e UC; cambiamenti nell'indice istologico di Nancy per UC e nel punteggio globale dell'attività istologica della malattia [GHAS] per CD;
    - proporzione di pazienti in remissione clinica (definita come CDAI<150 per CD o Mayo Score parziale <2 per CU) al basale, alle settimane 4, 12 e 24 di trattamento, e alla settimana 12 di follow-up; percentuale di pazienti che hanno raggiunto la remissione endoscopica (definita come SES-CD = 2 per CD o punteggio Mayo endoscopico <1 per CU) al basale e alla settimana 24 di trattamento; percentuale di pazienti che raggiunge la guarigione istologica (definita come GHAS =4 per MC o indice istologico di Nancy <1 per CU) al basale e alla settimana 24 di trattamento;
    - variazioni degli indici di attività ecografica (estensione della malattia, spessore della parete intestinale, segnali color-doppler, stratificazione della parete intestinale, grasso mesenterico infiammatorio e complicanze intestinali) alla settimana 24 di trattamento;
    - cambiamenti nella qualità della vita correlata alla salute: punteggio della scala analogica visiva (VAS) per il prurito, questionario sulle malattie epatiche croniche (CLDQ), questionario EQ-5D-5L, questionario sull'esito riportato dal paziente PSC (PSC-PRO), questionario sulle malattie infiammatorie intestinali (IBDQ).
    Tutti gli endpoint secondari saranno valutati dal basale a 6 mesi di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    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) 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 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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years3
    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 years3
    E.8.9.2In all countries concerned by the trial months0
    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 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: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study, patients will continue to be monitored according to regular clinical pratice
    I pazienti al termine dello studio continueranno il monitoraggio e gestione regolare secondo 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 Decision2022-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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