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    Summary
    EudraCT Number:2019-004474-26
    Sponsor's Protocol Code Number:FIL_PREVID
    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:2020-10-21
    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 number2019-004474-26
    A.3Full title of the trial
    Prephase treatment with prednisone +/- Vitamin D supplementation followed by immunochemotherapy in Elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL).
    A randomized, open label, phase III study by Fondazione Italiana Linfomi.
    Trattamento pre-fase con integrazione con prednisone +/- Vitamina D seguito da immunochemioterapia in pazienti anziani con linfoma diffuso a grandi cellule B (DLBCL).
    Uno studio randomizzato, in aperto, di fase III della Fondazione Italiana Linfomi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prephase treatment with prednisone +/- Vitamin D supplementation followed by immunochemotherapy in Elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL)
    Trattamento pre-fase con integrazione di prednisone +/- vitamina D seguita da immunochemioterapia nei pazienti anziani con linfoma diffuso a grandi cellule B (DLBCL)
    A.3.2Name or abbreviated title of the trial where available
    Prephase treatment with prednisone +/- Vitamin D supplementation followed by immunochemotherapy in E
    Trattamento pre-fase con integrazione di prednisone +/- vitamina D seguita da immunochemoterapia nei
    A.4.1Sponsor's protocol code numberFIL_PREVID
    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 SponsorFONDAZIONE ITALIANA LINFOMI ONLUS
    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 supportFondazione GRADE Onlus
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Italiana Linfomi Onlus
    B.5.2Functional name of contact pointUffici studi FIL - area startup
    B.5.3 Address:
    B.5.3.1Street AddressSpalto Marengo 44 c/o Uffici PACTO
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.3.4CountryItaly
    B.5.4Telephone number0131206129
    B.5.5Fax number0131263455
    B.5.6E-mailstartup@filinf.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 COLECALCIFEROLO SANDOZ
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz 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 nameCOLECALCIFEROLO SANDOZ
    D.3.2Product code [COLECALCIFEROLO SANDOZ]
    D.3.4Pharmaceutical form Oral solution
    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 INNCOLECALCIFEROLO
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codeCOLECALCIFEROLO SANDOZ
    D.3.9.3Other descriptive nameCholecalciferol is present in three different biological forms: cholecalciferol itself, which is the inactive and non-hydroxylated form of vitamin D3; calcidiol, which is the form whose values are measured in the blood; calcitriol, the biologically active form of vitamin D3. 7-dehydrocholesterol is the biological precursor of vitamin D3, which is transformed into cholecalciferol after exposure to ultraviolet radiation. Vitamin D plays a crucial role in controlling calcium metabolism together wi
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeVITAMINA D3
    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
    Elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL)
    Elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL)
    E.1.1.1Medical condition in easily understood language
    Elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL)
    Pazienti anziani con Linfoma diffuso a grandi cellule B (DLBCL)
    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 PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    The purpose of this trial is to demonstrate the superiority in terms of Progression-free survival
    (PFS) of a prephase therapy with oral prednisone and Vitamin D supplementation versus a
    prephase therapy with oral prednisone alone, followed by 6 cycles of conventional
    immunochemotherapy, on an elderly patients population diagnosed with Diffuse Large B-Cell
    Lymphoma (DLBCL) and Follicular lymphoma grade IIIb (FL3B).
    Obiettivo primario:
    Lo scopo di questo studio è dimostrare la superiorità in termini di sopravvivenza libera da progressione
    (PFS) di una terapia pre-fase con prednisone orale e integrazione di vitamina D rispetto a
    terapia pre-fase con solo prednisone orale, seguita da 6 cicli di convenzionale
    immunochemoterapia, su una popolazione di pazienti anziani con diagnosi di cellule B grandi diffuse
    Linfoma (DLBCL) e linfoma follicolare di grado IIIb (FL3B).
    E.2.2Secondary objectives of the trial
    ¿ to assess the safety of VitD supplementation in terms of hematological and extra
    hematological AEs rates;
    ¿ to evaluate the effect of VitD supplementation in terms of early mortality rate, response
    rate, OS, EFS;
    ¿ to confirm the efficacy of a prephase VitD supplementation to correct baseline
    25(OH)VitD levels;
    ¿ to identify prognostic factors for baseline 25(OH)VitD correction;
    ¿ to correlate 25(OH)VitD baseline levels with known and novel prognostic biomarkers
    (IPI, Cell of Origin, etc.) and with activity of immunochemotherapy;
    ¿ to identify potential mechanisms that correlate VitD levels with activity of
    immunochemotherapy;
    ¿ to identify high risk category of individuals showing insufficient response to Vitamin D
    supplementation;
    ¿ to describe the health-related quality of life (HRQoL) by the use of Patient-Reported
    Outcomes (PROs): EORTC-QLQ-C30 and FACT-Lym LymS questionnaires.
    valutare la sicurezza della supplementazione di VitD in termini ematologici ed extra
    tassi di eventi avversi ematologici;
    valutare l'effetto della supplementazione di VitD in termini di tasso di mortalità precoce, risposta
    tasso, sistema operativo, EFS;
    confermare l'efficacia di una supplementazione di VitD pre-fase per correggere la linea di base
    25 livelli di VitD (OH);
    identificare i fattori prognostici per la correzione della VitD al basale 25 (OH);
    correlare 25 livelli basali di VitD VitD con biomarcatori prognostici noti e nuovi
    (IPI, Cell of Origin, ecc.) E con attività di immunoemoterapia;
    identificare potenziali meccanismi che correlano i livelli di VitD con l'attività di
    immunochemioterapia;identificare la categoria ad alto rischio di individui che mostrano una risposta insufficiente alla vitamina D
    supplementazione;
    descrivere la qualità della vita correlata alla salute (HRQoL) mediante l'uso di pazienti segnalati
    Risultati (PRO): questionari EORTC-QLQ-C30 e FACT-Lym LymS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologically documented diagnosis of Diffuse Large B-cell Lymphoma or Follicular grade
    IIIb lymphoma, as defined in the 2017 edition of the World Health Organization (WHO)
    classification.
    2) Age = 65 years
    3) Comprehensive Geriatric Assessment (CGA) performed at baseline, before start of any
    treatment.
    4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) =3
    5) Eligibility for anthracycline containing regimen (R-CHOP or R-miniCHOP)
    6) No previous treatment for DLBCL or Follicular grade IIIb lymphoma
    7) Ann Arbor stage I-IV
    8) At least one site of measurable nodal disease at baseline = 1.5 cm in the longest
    transverse diameter as determined by CT scan (MRI is allowed only if CT scan cannot be
    performed); or one metabolic active site of disease at baseline FDG-PET scan
    9) Baseline Vitamin D [25(OH)VitD] serum level = 40 ng/ml
    10) Adequate hematological counts defined as follows:
    - Absolute Neutrophil count (ANC) > 1.5 x 109/L unless due to bone marrow
    involvement by lymphoma
    - Platelet count = 80.000/mm3 unless due to bone marrow involvement by lymphoma
    11) Adequate renal function defined as follows:
    - Creatinine = 2 mg/dL, unless secondary to lymphoma
    12) Adequate hepatic function defined as follows:
    - Bilirubin = 2 mg/dL unless secondary to lymphoma
    13) LVEF > 50% at bidimensionally echocardiogram
    14) Life expectancy = 6 months
    15) Subject understands and voluntarily signs an informed consent form approved by an
    Independent Ethics Committee (IEC), prior to the initiation of any screening or studyspecific
    procedures
    16) Subject must be able to adhere to the study visit schedule and other protocol requirements
    17) Men must agree to use one of the below reported acceptable method of contraception (for
    themselves or female partners if WOCBP) for the duration of the study and for 3 months
    after receiving the last dose of immunochemotherapy, and to not donate sperm while on
    study.
    Acceptable methods for birth control, to be adopted even if male is surgically sterilized (i.e.,
    status post vasectomy) are:
    - practice effective barrier contraception during the entire study treatment period and
    through 3 months after the last dose of immunochemotherapy, or
    - agree to practice true abstinence, when this is in line with the preferred and usual
    lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal,
    post ovulation methods for the female partner] and withdrawal are not acceptable
    methods of contraception)
    1) Diagnosi istologicamente documentata del linfoma diffuso a grandi cellule B o del grado follicolare
    Linfoma IIIb, come definito nell'edizione 2017 dell'Organizzazione mondiale della sanità (OMS)
    classificazione.
    2) Età = 65 anni
    3) Valutazione geriatrica completa (CGA) eseguita al basale, prima dell'inizio di qualsiasi
    trattamento.
    4) Stato delle prestazioni del gruppo di oncologia cooperativa orientale (ECOG) (PS) =3
    5) Ammissibilità al regime contenente antraciclina (R-CHOP o R-miniCHOP)
    6) Nessun precedente trattamento per DLBCL o linfoma follicolare di grado IIIb
    7) Ann Arbor stage I-IV
    8) Almeno un sito di malattia nodale misurabile al basale = 1,5 cm nella più lunga
    diametro trasversale come determinato dalla TAC (la risonanza magnetica è consentita solo se la TAC non può essere
    eseguita); o un sito metabolico attivo della malattia alla scansione FDG-PET al basale
    9) Livello sierico di vitamina D [25 (OH) VitD] al basale = 40 ng / ml
    10) Conti ematologici adeguati definiti come segue:
    - Conta assoluta dei neutrofili (ANC)> 1,5 x 109 / L se non dovuta al midollo osseo
    coinvolgimento del linfoma
    - Conta piastrinica = 80.000 / mm3 se non a causa del coinvolgimento del midollo osseo da parte del linfoma
    11) Funzione renale adeguata definita come segue:
    - Creatinina = 2 mg / dL, a meno che non sia secondaria al linfoma
    12) Funzione epatica adeguata definita come segue:
    - Bilirubina = 2 mg / dL se non secondaria al linfoma
    13) LVEF> 50% all'ecocardiogramma bidimensionale
    14) Speranza di vita = 6 mesi
    15) Il soggetto comprende e firma volontariamente un modulo di consenso informato approvato da un
    Comitato Etico Indipendente (IEC), prima dell'inizio di qualsiasi screening o studio specifico
    procedure
    16) Il soggetto deve essere in grado di aderire al programma delle visite di studio e ad altri requisiti del protocollo
    17) Gli uomini devono accettare di utilizzare uno dei metodi contraccettivi accettabili riportati di seguito (per
    se stesse o partner femminili se WOCBP) per la durata dello studio e per 3 mesi
    dopo aver ricevuto l'ultima dose di immunochemoterapia e di non donare spermatozoi durante il trattamento
    studia.
    Metodi accettabili per il controllo delle nascite, da adottare anche se il maschio è sterilizzato chirurgicamente (ad es.
    status post vasectomia) sono:
    - praticare una contraccezione di barriera efficace durante l'intero periodo di trattamento dello studio e
    fino a 3 mesi dopo l'ultima dose di immunochemoterapia, oppure
    - accetta di praticare la vera astinenza, quando ciò è in linea con il preferito e il solito
    stile di vita del soggetto. (Astinenza periodica [ad es. Calendario, ovulazione, sintotermia,
    i metodi post ovulazione per la partner femminile] e il ritiro non sono accettabili
    metodi di contraccezione)
    E.4Principal exclusion criteria
    1) Histological diagnosis different from Diffuse large B-Cell Lymphoma or Follicular grade IIIb
    lymphoma
    2) HGBL, with rearrangement of MYC, BCL2 and/or BCL6 (double-hit)
    3) Use of VitD supplementation as standard of care at dose higher than 10.000 U/week (or
    higher than 2,000 U/day)
    4) Suspect or clinical evidence of CNS involvement by lymphoma
    5) Contraindication to the use of rituximab
    6) Contraindication to the use of VitD supplementation (Hypercalcemia/Hyperphosphatemia)
    7) Subject has received any anti-cancer therapy including chemotherapy, immunotherapy,
    radiotherapy, investigational therapy, including targeted small molecule agents within 14
    days prior to the first dose of study drug
    8) Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or
    hepatic disease that would preclude participation in the study or compromise ability to give
    informed consent
    9) Any history of other active malignancies within 2 years prior to study entry, with the
    exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma
    of the skin or localized squamous cell carcinoma of the skin or limited stage surgically
    removed breast cancer or adequately treated with radiation therapy or limited stage
    prostate carcinoma surgically removed or adequately treated with radiation therapy
    previous malignancy confined and surgically resected with curative intent
    10) Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
    - Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
    - Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note:
    subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface
    (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc)
    antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins
    (IVIG) may participate
    1) Diagnosi istologica diversa dal linfoma diffuso a grandi cellule B o dal grado follicolare IIIb
    linfoma
    2) HGBL, con riarrangiamento di MYC, BCL2 e / o BCL6 (doppio colpo)
    3) Uso della supplementazione di VitD come standard di cura a dosi superiori a 10.000 U / settimana (o
    superiore a 2.000 U / giorno)
    4) Sospetto o evidenza clinica del coinvolgimento del SNC nel linfoma
    5) Controindicazione all'uso di rituximab
    6) Controindicazione all'uso della supplementazione di VitD (Ipercalcemia / Iperfosfatemia)
    7) Il soggetto ha ricevuto qualsiasi terapia anticancro, inclusi chemioterapia, immunoterapia,
    radioterapia, terapia sperimentale, compresi agenti molecolari di piccole dimensioni mirati entro 14
    giorni prima della prima dose del farmaco in studio
    8) Storia significativa di neurologici, psichiatrici, endocrinologici, metabolici, immunologici o
    malattia epatica che precluderebbe la partecipazione allo studio o comprometterebbe la capacità di dare
    consenso informato
    9) Qualsiasi storia di altre neoplasie attive entro 2 anni prima dell'ingresso nello studio, con il
    eccezione del carcinoma in situ adeguatamente trattato della cervice uterina, carcinoma a cellule basali
    della pelle o carcinoma localizzato a cellule squamose della pelle o stadio limitato chirurgicamente
    rimosso il carcinoma mammario o adeguatamente trattato con radioterapia o stadio limitato
    carcinoma prostatico rimosso chirurgicamente o adeguatamente trattato con radioterapia
    malignità precedente confinata e chirurgicamente resecata con intento curativo
    10) Evidenza di altre condizioni clinicamente significative non controllate tra cui, ma non limitato a:
    - Infezione sistemica non controllata e / o attiva (virale, batterica o fungina)
    - Virus dell'epatite B cronica (HBV) o dell'epatite C (HCV) che richiedono un trattamento. Nota:
    soggetti con evidenza sierologica di una precedente vaccinazione contro l'HBV (cioè superficie dell'epatite B.
    (HBs) antigene negativo, anti-HBs anticorpo positivo e anti-epatite B core (HBc)
    anticorpo negativo) o anticorpo anti-HBc positivo da immunoglobuline per via endovenosa
    (IVIG) può partecipare
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    Progression-Free Survival (PFS)
    Endpoint primario:
    Sopravvivenza libera da progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    2-year PFS.
    PFS di 2 anni.
    E.5.2Secondary end point(s)
    Secondary Endpoints
    ¿ Overall Survival (OS)
    ¿ Event Free Survival (EFS)
    ¿ Response rate (ORR, CRR; Cheson 2014)
    ¿ Early mortality rate: all deaths recorded within 90 days from the date of diagnosis
    ¿ AEs CTCAE current version
    ¿ Rate of ECOG changes after prephase
    ¿ Rate of 25(OH)VitD correction (VitD supplementation arm): number of patients with
    25(OH)VitD levels above or equal 20ng/ml at day 1 of cycle 2
    ¿ Rate of patients who maintain 25(OH)VitD levels in the normal range at cycle 6
    ¿ PRO endpoints include: time-to-deterioration in EORTC QLQ-C30 physical functioning
    and fatigue and FACT-Lym LymS; proportion of patients in each arm achieving
    meaningful improvement in EORTC QLQ-C30 physical functioning and fatigue, and
    FACT-Lym LymS; and a comparison of EORTC QLQ-C30 treatment-related symptoms
    between the two treatment arms.
    Endpoint secondari
    ¿ Sopravvivenza globale (OS)
    ¿ Event Free Survival (EFS)
    ¿ Tasso di risposta (ORR, CRR; Cheson 2014)
    ¿ Tasso di mortalità precoce: tutti i decessi registrati entro 90 giorni dalla data della diagnosi
    ¿ Versione corrente di AECA CTCAE
    ¿ Tasso di modifiche ECOG dopo la fase preliminare
    ¿ Percentuale di correzione della VitD 25 (OH) (braccio di integrazione della VitD): numero di pazienti con
    25 (OH) livelli di VitD superiori o uguali a 20 ng / ml al giorno 1 del ciclo 2
    ¿ Tasso di pazienti che mantengono 25 livelli di VitD (OH) nell'intervallo normale al ciclo 6
    ¿ Gli endpoint PRO comprendono: tempo al deterioramento nel funzionamento fisico EORTC QLQ-C30
    e fatica e FACT-Lym LymS; percentuale di pazienti che raggiungono ciascun braccio
    miglioramento significativo del funzionamento fisico e della fatica dell'EORTC QLQ-C30, e
    FACT-Lym LymS; e un confronto dei sintomi correlati al trattamento EORTC QLQ-C30
    tra i due bracci di trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The best overall response will be defined as the best response between the date of beginning of
    therapy and the last restaging. Patients without response assessment (due to whatever reason)
    will be considered as non-responders.
    Patients who will interrupt therapy (for any reason) will be followed for survival up to 12 months
    after treatment discontinuation.
    La migliore risposta globale verrà definita come la migliore risposta tra la data di inizio di
    terapia e l'ultimo riposo. Pazienti senza valutazione della risposta (per qualsiasi motivo)
    saranno considerati non rispondenti.
    I pazienti che interromperanno la terapia (per qualsiasi motivo) saranno seguiti per la sopravvivenza fino a 12 mesi
    dopo l'interruzione del trattamento.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    11/5000 superiority
    superiorità
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    pazienti nel Il braccio sperimentale (braccio B) riceverà anche una terapia pre-fase con VitD.
    patients in the Experimental arm (Arm B) will receive also a prephase therapy with VitD.
    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 concerned49
    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
    End of study is defined by the last visit planned by the protocol 12 months after the end of treatment of
    the last patient enrolled (LPLV), that means approximately 54 months (4,5 years) after the study start.
    The Final Study Report will be provided after the end of the Study.
    La fine dello studio è definita dall'ultima visita pianificata dal protocollo 12 mesi dopo la fine del trattamento di
    l'ultimo paziente arruolato (LPLV), ciò significa circa 54 mesi (4,5 anni) dopo l'inizio dello studio.
    Il rapporto di studio finale verrà fornito dopo la fine dello studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 430
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state430
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 430
    F.4.2.2In the whole clinical trial 430
    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)
    430 patients (215 by arms)
    430 pazienti (215 per braccio)
    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 Decision2020-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-14
    P. End of Trial
    P.End of Trial StatusOngoing
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