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    Summary
    EudraCT Number:2022-001759-17
    Sponsor's Protocol Code Number:FGTW2101
    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:2022-10-03
    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 number2022-001759-17
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 study to assess the efficacy and safety of fibrinogen concentrate (FGTW) in the management of bleeding in patients undergoing complex cardiac surgery (involving CPB)
    Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per la valutazione dell’efficacia e della sicurezza del concentrato di fibrinogeno (FGTW) nella gestione del sanguinamento in pazienti sottoposti a interventi di cardiochirurgia complessi (con impiego di bypass cardiopolmonare (CPB))
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of fibrinogen concentrate (FGTW) compared to placebo in the management of bleeding in patients undergoing complex cardiac surgery
    Studio sul confronto tra concentrato di fibrinogeno (FGTW) e placebo nella gestione del sanguinamento in pazienti sottposto a interventi di cardiochirurgia complessi (con impiego di bypass cardiopolomonare (CPB))
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberFGTW2101
    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 SponsorLFB BIOTECHNOLOGIES
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLaboratoire français du Fractionnement et des Biotechnologies (LFB BIOTECHNOLOGIES)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB BIOTECHNOLOGIES
    B.5.2Functional name of contact pointClinical Trial information desk
    B.5.3 Address:
    B.5.3.1Street Address3, avenue des Tropiques, BP 40305 - LES ULIS
    B.5.3.2Town/ cityCOURTABOEUF CEDEX
    B.5.3.3Post code91958
    B.5.3.4CountryFrance
    B.5.4Telephone number003369827010
    B.5.5Fax number003369827272
    B.5.6E-mailna@na.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 FibCLOT
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire français du Fractionnement et des Biotechnologies
    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 nameFibCLOT®/ FibriCLOTte®
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFibrinogeno umano
    D.3.9.1CAS number 9001-32-5
    D.3.9.2Current sponsor codeFGTW (or FGT1)
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bleeding in patients undergoing complex cardiac surgery (involving CPB)
    Sanguinamento nei pazienti sottoposti a cardiochirurgia complessa (che coinvolge CPB)
    E.1.1.1Medical condition in easily understood language
    Bleeding in patients undergoing complex cardiac surgery involving Cardiopulmonary bypass
    Sanguinamento in pazienti sottoposti a chirurgia cardiaca complessa che coinvolge bypass cardiopolmonare
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10017501
    E.1.2Term Functional disturbances following cardiac surgery
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of FGTW in combination with Standard of care in reducing the need for allogeneic transfusions within the first 24 hours after randomization in complex cardiac surgery patients.
    L'obiettivo principale dello studio è valutare l'efficacia di FGTW in combinazione con lo Standard of care nel ridurre la necessità di trasfusioni allogeniche entro le prime 24 ore dopo la randomizzazione in pazienti sottoposti a cardiochirurgia complessa.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the number and volume of RBC, FFP, and platelet concentrate transfusions in the 24 hours after randomization until hospital discharge
    - To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the blood drainage volume within 12 hours after randomization
    - To evaluate the number of patients with total avoidance of allogeneic transfusions after randomization
    - To evaluate the safety of FGTW
    - To evaluate the impact of FGTW on mortality and surgical morbidity
    - Valutare l'efficacia associata all'uso di FGTW rispetto a Placebo nel ridurre il numero e il volume delle trasfusioni di concentrato di globuli rossi, FFP e piastrine nelle 24 ore dopo la randomizzazione fino alla dimissione dall'ospedale
    - Valutare l'efficacia associata all'uso di FGTW rispetto al placebo nel ridurre il volume di drenaggio del sangue entro 12 ore dalla randomizzazione
    - Valutare il numero di pazienti con totale utilizzo delle trasfusioni allogeniche dopo la randomizzazione
    - Valutare la sicurezza di FGTW
    - Valutare l'impatto di FGTW sulla mortalità e morbilità chirurgica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient must meet all the following criteria to be eligible to participate in this study:
    1. Male or female adult patients >=18 years
    2. Patients undergoing a planned complex cardiac surgery procedure involving CPB, including reoperation and/or complex surgical procedures. Complex surgical procedures are defined as any procedure other than first time isolated coronary artery bypass grafting (CABG), single valve
    repair/replacement and repair of atrial septal defect (ASD). This criterion represents the main eligibility criterion and so used in the definition of the full analysis set.
    3. With a FIBTEM MCF <=8 mm during the last 20 minutes of CPB.
    4. Patients requiring an IMP dose <=8 g calculated with the formula based on patient’s weight and the value of FIBTEM MCF
    5. Signed and dated informed consent form (ICF)
    6. Willingness to comply with all study procedures and availability for the duration of the study
    7. Covered by healthcare insurance in accordance with local requirements
    Un paziente deve soddisfare tutti i seguenti criteri per essere idoneo a partecipare a questo studio:
    1. Pazienti adulti maschi o femmine >= 18 anni
    2. Pazienti sottoposti a una procedura di cardiochirurgia complessa pianificata che coinvolge CPB, inclusi reintervento e/o procedure chirurgiche complesse. Per procedure chirurgiche complesse si intende qualsiasi procedura diversa dal primo innesto di bypass coronarico isolato (CABG), valvola singola
    riparazione/sostituzione e riparazione del difetto interatriale (ASD). Tale criterio rappresenta il principale criterio di ammissibilità e quindi utilizzato nella definizione dell'insieme di analisi completo.
    3. Con un FIBTEM MCF <=8 mm durante gli ultimi 20 minuti di CPB.
    4. Pazienti che necessitano di una dose IMP <=8 g calcolata con la formula basata sul peso del paziente e il valore di FIBTEM MCF
    5. Modulo di consenso informato (ICF) firmato e datato
    6. Disponibilità a rispettare tutte le procedure di studio e disponibilità per la durata dello studio
    7. Coperto da assicurazione sanitaria in conformità con i requisiti locali
    E.4Principal exclusion criteria
    A patient who meets any of the following criteria will be excluded from participation in this study:
    1. Heart transplantation
    2. Repair of complex congenital abnormalities
    3. Any known pulmonary, hepatic, or renal disease or any other major concomitant significant medical condition that might interfere with treatment evaluation according to the Investigator’s judgment
    4. Known hypersensitivity or other severe reaction to any component of the IMP
    5. Patients at high risk of thrombotic events unable to stop prophylactic low-molecular-weight heparin
    (LMWH) 12 hours and fondaparinux 24 hours before surgery (longer interval in case of impaired renal function)
    6. Patients unable to stop treatment by vitamin K antagonists 3-5 days before surgery to obtain an international normalized ratio (INR) <1.5
    7. Patients unable to stop treatment by direct oral anticoagulant at least 48 hours before surgery (except aspirin)
    8. Patients unable to stop treatment by P2Y12 inhibitors before surgery (discontinuation duration before surgery: ticagrelor 3 days, clopidogrel 5 days, and prasugrel 7 days) [30]
    9. Severe anemia with hemoglobin (Hb) =10 g/dL
    10. Excessive hemodilution during CPB with hematocrit (Ht) <22% in men and women
    11. Congenital coagulation deficiencies (von Willebrand disease, factor V Leiden, Protein C deficiency, cryoglobulinemia, antiphospholipid syndrome…)
    12. Any known thromboembolic disorder
    13. Female of reproductive potential not using effective contraception (condoms; occlusive caps with
    spermicide; injectable, patch, or combined oral estro-progestative or progestative contraceptives; depot intramuscular medroxyprogesterone; or subcutaneous implants of progestative contraceptive implants) for at least one month prior to screening
    14. Known pregnancy or positive blood pregnancy test for women of childbearing potential and/or breast-feeding women
    15. Participation in another clinical study involving an investigational medicinal product within 30 days prior to screening or concomitantly with this study
    16. Previous cardiac surgical procedure within three months before randomization
    17. Evidence or suspicion of infection (fever >38.5°C and white blood cell count >11/mm3)
    18. Active endocarditis
    19. Emergency surgery, patients in cardiogenic shock, or expected mortality within 24 hours of surgery
    20. Pre-existing thrombocytopenia with platelet count < 150 000/ mm3
    Un paziente che soddisfi uno qualsiasi dei seguenti criteri sarà escluso dalla partecipazione a questo studio:
    1. Trapianto di cuore
    2. Riparazione di anomalie congenite complesse
    3. Qualsiasi malattia polmonare, epatica o renale nota o qualsiasi altra condizione medica significativa concomitante che potrebbe interferire con la valutazione del trattamento secondo il giudizio dello sperimentatore
    4. Ipersensibilità nota o altra reazione grave a qualsiasi componente dell'IMP
    5. Pazienti ad alto rischio di eventi trombotici incapaci di interrompere la profilassi con eparina a basso peso molecolare
    (LMWH) 12 ore e fondaparinux 24 ore prima dell'intervento chirurgico (intervallo più lungo in caso di funzionalità renale compromessa)
    6. Pazienti incapaci di interrompere il trattamento con antagonisti della vitamina K 3-5 giorni prima dell'intervento chirurgico per ottenere un rapporto internazionale normalizzato (INR) <1,5
    7. Pazienti incapaci di interrompere il trattamento con anticoagulante orale diretto almeno 48 ore prima dell'intervento chirurgico (eccetto l'aspirina)
    8. Pazienti incapaci di interrompere il trattamento con inibitori della P2Y12 prima dell'intervento chirurgico (durata dell'interruzione prima dell'intervento chirurgico: ticagrelor 3 giorni, clopidogrel 5 giorni e prasugrel 7 giorni) [30]
    9. Anemia grave con emoglobina (Hb) =10 g/dL
    10. Eccessiva emodiluizione durante CPB con ematocrito (Ht) <22% negli uomini e nelle donne
    11. Deficit della coagulazione congenita (malattia di von Willebrand, fattore V Leiden, carenza di proteina C, crioglobulinemia, sindrome da anticorpi antifosfolipidi…)
    12. Qualsiasi disturbo tromboembolico noto
    13. Donne in età riproduttiva che non usano metodi contraccettivi efficaci (preservativi; cappucci occlusivi con spermicida; contraccettivi orali estro-progestativi o progestinici iniettabili, cerotti o combinati; deposito di medrossiprogesterone intramuscolare; o impianti sottocutanei di impianti contraccettivi progestinici) per almeno un mese prima dello screening
    14. Gravidanza nota o test di gravidanza su sangue positivo per donne in età fertile e/o che allattano
    15. Partecipazione a un altro studio clinico che coinvolge un medicinale sperimentale entro 30 giorni prima dello screening o in concomitanza con questo studio
    16. Precedente procedura cardiochirurgica entro tre mesi prima della randomizzazione
    17. Evidenza o sospetto di infezione (febbre >38,5°C e conta leucocitaria >11/mm3)
    18. Endocardite attiva
    19. Chirurgia d'urgenza, pazienti in shock cardiogeno o mortalità attesa entro 24 ore dall'intervento
    20. Trombocitopenia preesistente con conta piastrinica < 150.000/ mm3
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    The primary efficacy endpoint is the number of units of allogeneic blood products (RBC plus FFP plus platelet concentrate) given to patients between randomization and 24 hours thereafter.
    Endpoint primario di efficacia
    L'endpoint primario di efficacia è il numero di unità di emoderivati ¿¿allogenici (RBC più FFP più concentrato piastrinico) somministrate ai pazienti tra la randomizzazione e le 24 ore successive.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated 24 hours after randomization.
    L'endpoint primario sarà valutato 24 ore dopo la randomizzazione.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are defined as follows:
    1. Blood drainage volume within 12 hours after randomization
    2. Percentage of patients with total avoidance of allogeneic transfusions within 24 hours after randomization
    3. Number of transfusion units infused in the 24 hours after randomization until hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate)
    4. Volume of transfusion units infused in the 24 hours after randomization until hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate)
    5. Number of pre-donated autologous RBC concentrate units, RBC concentrate prepared by cell-saver, colloids, and crystalloids after randomization
    6. Mortality at 24 hours, 7 days, and 30 days after randomization
    7. Percentage of patients with each surgical morbidity at 24 hours, 7 days, and 30 days after randomization (see Section 9.2.8)
    8. Percentage of patients with post-surgery stage 1 AKI (with increase in creatinine by >50% from baseline until EoS visit)
    9. Percentage of patients with surgical re-exploration for bleeding within 24 hours after randomization
    10. Percentage of patients with fibrinogen concentration below the LLN until hospital discharge
    11. Percentage of patients receiving aPCCs, rFVIIa, cryoprecipitate or additional FC as rescue therapy within 24 hours after randomization
    Gli endpoint secondari di efficacia sono definiti come segue:
    1. Volume di drenaggio del sangue entro 12 ore dalla randomizzazione
    2. Percentuale di pazienti che evitano totalmente le trasfusioni allogeniche entro 24 ore dalla randomizzazione
    3. Numero di unità trasfusionali infuse nelle 24 ore successive alla randomizzazione fino alla dimissione ospedaliera per ciascuna classe di emoderivati ¿¿allogenici (RBC, FFP e concentrato piastrinico)
    4. Volume delle unità trasfusionali infuse nelle 24 ore successive alla randomizzazione fino alla dimissione ospedaliera per ciascuna classe di emoderivati ¿¿allogenici (RBC, FFP e concentrato piastrinico)
    5. Numero di unità di concentrato di globuli rossi autologhi predonati, concentrato di globuli rossi preparato da cell-saver, colloidi e cristalloidi dopo la randomizzazione
    6. Mortalità a 24 ore, 7 giorni e 30 giorni dopo la randomizzazione
    7. Percentuale di pazienti con ciascuna morbilità chirurgica a 24 ore, 7 giorni e 30 giorni dopo la randomizzazione (vedere Sezione 9.2.8)
    8. Percentuale di pazienti con AKI di stadio 1 post-operatorio (con aumento della creatinina di >50% dal basale fino alla visita EoS)
    9. Percentuale di pazienti con riesplorazione chirurgica per sanguinamento entro 24 ore dalla randomizzazione
    10. Percentuale di pazienti con concentrazione di fibrinogeno inferiore al LLN fino alla dimissione dall'ospedale
    11. Percentuale di pazienti che hanno ricevuto aPCC, rFVIIa, crioprecipitato o FC aggiuntiva come terapia di salvataggio entro 24 ore dalla randomizzazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints for the secondary end points listed under E.5.2 are as follows:
    1. Within 12 hours after randomization
    2. Within 24 hours after randomization
    3. In the 24 hours after randomization until hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate)
    4. In the 24 hours after randomization until hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate)
    5. After randomization
    6. At 24 hours, 7 days, and 30 days after randomization
    7. At 24 hours, 7 days, and 30 days after randomization
    8. From baseline until EoS visit
    9. Within 24 hours after randomization
    10. From the point fibrinogen concentration is below the LLN until hospital discharge
    11. Within 24 hours after randomization
    I tempi per end point secondari elencati in E.5.2 sono: 1. Entro 12 ore da randomizzazione; 2. Entro 24 ore da randomizzazione; 3. Nelle 24 ore successive a randomizzazione fino a dimissione ospedaliera per ciascuna classe di emoderivati allogenici (RBC, FFP e concentrato piastrinico); 4. Nelle 24 ore successive a randomizzazione fino a dimissione ospedaliera per ciascuna classe di emoderivati allogenici (RBC, FFP e concentrato piastrinico); 5. Dopo randomizzazione; 6. A 24 ore, 7 giorni e 30 giorni dopo randomizzazione;7. A 24 ore, 7 giorni e 30 giorni dopo la randomizzazione; 8. Dal basale fino alla visita EoS; 9. Entro 24 ore dalla randomizzazione; 10. Dal punto la concentrazione di fibrinogeno è inferiore al LLN fino alla dimissione dall'ospedale; 11. Entro 24 ore dalla randomizzazione
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Sweden
    Spain
    Germany
    Italy
    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 months1
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days3
    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: 158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 176
    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. Patients will return to standard of care treatment.
    Nessuno. I pazienti torneranno al trattamento di cura standard
    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 Decision2022-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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    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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