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    Summary
    EudraCT Number:2021-004931-10
    Sponsor's Protocol Code Number:R3918-PNH-2050
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-11-07
    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 number2021-004931-10
    A.3Full title of the trial
    An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria
    Studio di estensione in aperto per valutare la sicurezza, la tollerabilità e l’efficacia a lungo termine della terapia di combinazione con pozelimab e cemdisiran in pazienti
    affetti da emoglobinuria parossistica notturna
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the long-term safety, tolerability, and effectiveness of Pozelimab and Cemdisiran combination therapy in adult patients with Paroxysmal Nocturnal Hemoglobinuria
    Uno studio per esaminare la sicurezza, la tollerabilità e l'efficacia a lungo termine della terapia combinata di Pozelimab e Cemdisiran in pazienti adulti con emoglobinuria parossistica notturna
    A.3.2Name or abbreviated title of the trial where available
    ACCESS-EXTENSION
    ACCESS-EXTENSION
    A.4.1Sponsor's protocol code numberR3918-PNH-2050
    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 SponsorREGENERON PHARMACEUTICALS, INC.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 namePozelimab
    D.3.2Product code [REGN3918]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPozelimab
    D.3.9.2Current sponsor codeREGN3918
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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.IMP: 2
    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 Yes
    D.2.5.1Orphan drug designation number0000061148
    D.3 Description of the IMP
    D.3.1Product nameCemdisiran
    D.3.2Product code [ALN-CC5]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCemdisiran
    D.3.9.2Current sponsor codeALN-CC5
    D.3.9.4EV Substance CodeSUB217110
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    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 namePozelimab
    D.3.2Product code [REGN3918]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPozelimab
    D.3.9.2Current sponsor codeREGN3918
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Paroxysmal nocturnal hemoglobinuria (PNH)
    Emoglobinuria parossistica notturna (EPN)
    E.1.1.1Medical condition in easily understood language
    Paroxysmal nocturnal hemoglobinuria (PNH)
    Emoglobinuria parossistica notturna (EPN)
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10055629
    E.1.2Term Paroxysmal nocturnal hemoglobinuria
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to describe the long-term safety, tolerability, and efficacy of pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria (PNH)
    L’obiettivo primario dello studio è descrivere la sicurezza, la tollerabilità e l’efficacia a lungo termine della terapia di combinazione con pozelimab e cemdisiran
    in pazienti affetti da emoglobinuria parossistica notturna (EPN).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to describe the long-term effect of the combination of pozelimab and cemdisiran on:
    • Measures of intravascular hemolysis
    • Transfusion parameters
    • Hemoglobin levels
    • Fatigue as assessed by a Patient Reported Outcome (PRO)
    • Physical Function as assessed by a PRO
    • Change in Global Health Status (GHS) as assessed by a PRO
    • Complement activation
    • Concentrations of total pozelimab in serum and cemdisiran and total
    complement component 5 (C5) protein in plasma
    • Immunogenicity of pozelimab & cemdisiran
    Gli obiettivi secondari dello studio sono descrivere gli effetti a lungo termine della combinazione di pozelimab e cemdisiran su:
    • misurazioni dell’emolisi intravascolare
    • parametri di trasfusione
    • livelli di emoglobina
    • affaticamento valutato mediante un esito riferito dal paziente (Patient Reported Outcome, [PRO])
    • funzionalità fisica valutata mediante un PRO
    • variazione nello stato di salute globale (Global Health Status, [GHS]) valutata mediante un PRO
    • attivazione del complemento
    • concentrazioni di pozelimab totale nel siero e cemdisiran e della proteina componente 5 (C5) del complemento totale nel plasma
    • immunogenicità di pozelimab e cemdisiran
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenomics
    Version: Original
    Date: 07/02/2022
    Title: An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria
    Objectives: Future Biomedical Research: Patients who agree to participate in the future biomedical research (FBR) sub-study will be required to consent to this optional sub-study before samples are banked for FBR. The samples may be utilized for FBR that may or may not be directly related to the study, including being used as reference samples and assay development or validation. The results of these future biomedical research analyses will not be presented in the CSR. Pharmacogenomic Analysis: Patients who agree to participate in the genomics sub-study will be required to consent to this optional sub-study before collection of the samples. The purpose of the pharmacogenomic analyses is to identify genomic associations with clinical or biomarker response to pozelimab and cemdisiran, other PNH clinical outcome measures and possible AEs. In addition, associations between genomic variants and prognosis or progression of PNH as well as related complementmediated diseases may also be studied. These data may be used or combined with data collected from other studies to identify and validate genomic markers related to the study drug, target pathway, or PNH and related diseases.

    Farmacogenomica
    Versione: Original
    Data: 07/02/2022
    Titolo: Studio di estensione in aperto per valutare la sicurezza, la tollerabilità e l’efficacia a lungo termine della terapia di combinazione con pozelimab e cemdisiran in pazienti affetti da emoglobinuria parossistica notturna
    Obiettivi: Ricerca futura biomedica: I pazienti che accettano di partecipare alla ricerca futura biomedica (FBR) sarà richiesto di acconsentire a questo sottostudio facoltativo prima che i campioni vengano depositati per FBR. I campioni possono essere utilizzati per FBR che possono o non possono essere direttamente correlati allo studio, compreso l'utilizzo come campioni di riferimento e sviluppo o convalida del test. I risultati di queste analisi future di ricerca biomedica non saranno presentati nella CSR. Analisi farmacogenomica: I pazienti che accetteranno di partecipare al sottostudio di genomica dovranno acconsentire a questo sottostudio facoltativo prima della raccolta dei campioni. Lo scopo delle analisi farmacogenomiche è quello di identificare associazioni genomiche con la risposta clinica o di biomarcatori a pozelimab e cemdisiran, altre misure di esito clinico della EPN e possibili eventi avversi. Inoltre, possono essere anche studiate le associazioni tra varianti genomiche e prognosi o progressione della EPN così come le relative malattie relative dal complemento. Questi dati possono essere utilizzati o combinati con i dati raccolti da altri studi per identificare e convalidare marcatori genomici correlati al farmaco in studio, alla via bersaglio o alla EPN e malattie correlate.
    E.3Principal inclusion criteria
    1. Patients with PNH who have completed, without permanent discontinuation, study treatment in at least 1 of the parent studies (R3918-PNH-2021 [NCT05133531] and/or R3918-PNH-2022 [NCT05131204]) including the transition period, if applicable.

    Other protocol-defined Inclusion Criteria apply
    1. Pazienti affetti da EPN che hanno completato, senza interruzione permanente, il trattamento dello studio in almeno 1 degli studi originari (R3918-PNH-2021 [NCT05133531] e/o R3918-PNH-2022 [NCT05131204]), incluso il periodo di transizione, se pertinente.

    Si applicano altri criteri di inclusione definiti dal protocollo.
    E.4Principal exclusion criteria
    1. Significant protocol deviation(s) in the parent study based on the investigator’s judgment and to the extent that these would (if continued) impact the study objectives and/or safety of the patient (eg, repetitive non-compliance with dosing by the patient).
    2. Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study.

    Other protocol-defined Exclusion Criteria apply
    1. Deviazione/i significativa/e dal protocollo nello studio originario in base al giudizio dello sperimentatore e nella misura in cui questa/e influenzerebbe/ro (se
    continuata/e) gli obiettivi dello studio e/o la sicurezza del paziente (per es., non conformità ripetuta al dosaggio da parte del paziente).
    2. Qualsiasi nuova condizione o peggioramento di una condizione esistente che, a giudizio dello sperimentatore, renderebbe il paziente non idoneo all'arruolamento o
    potrebbe interferire con la partecipazione o il completamento dello studio da parte del paziente.

    Si applicano altri criteri di esclusione definiti dal protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and severity of treatment-emergent serious adverse events (SAEs)
    2. Incidence and severity of treatment-emergent adverse events of special interest (AESIs)
    3. Treatment emergent adverse events (AEs) leading to permanent treatment discontinuation
    4. Maintenance of adequate control of hemolysis
    1. Incidenza e gravità degli eventi avversi gravi (SAE) emergenti dal trattamento
    2. Incidenza e gravità degli eventi avversi di particolare interesse (AESI) emergenti dal trattamento
    3. Eventi avversi (EA) emergenti dal trattamento che portano all'interruzione permanente del trattamento
    4. Mantenimento di un adeguato controllo dell'emolisi
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-3: Up to week 108
    4: Post-baseline to week 36
    1-3: Fino alla settimana 108
    4: Post-basale fino alla settimana 36
    E.5.2Secondary end point(s)
    1. Maintenance of adequate control of hemolysis
    2. Adequate control of hemolysis
    3. Transfusion avoidance
    4. Breakthrough hemolysis
    5. Hemoglobin stabilization
    6. Percent change in lactate dehydrogenase (LDH)
    7. Change in fatigue as measured by the FACIT-Fatigue scale
    8. Change in physical function (PF) scores on the EORTC QLQ-C30
    9. Change in GHS/quality of life (QOL) scale on the EORTC QLQ-C30
    10. Normalization of LDH
    11. Rate of RBC transfusion
    12. Number of units of RBC transfusion
    13. Percentage of days with LDH <=1.5x upper limit of normal (ULN)
    14. Change in hemoglobin levels
    15. Change in CH50
    16. Percent change in CH50
    17. Concentrations of total pozelimab in serum
    18. Concentrations of cemdisiran in plasma
    19. Incidence of treatment-emergent anti-drug antibodies to pozelimab
    20. Incidence of treatment-emergent anti-drug antibodies to cemdisiran
    21. Concentration of total C5 in plasma
    22. Percent change of concentration of total C5 in plasma
    1. Mantenimento di un adeguato controllo dell'emolisi
    2. Controllo adeguato dell'emolisi
    3. Prevenzione delle trasfusioni
    4. Emolisi episodica
    5. Stabilizzazione dell'emoglobina
    6. Variazione percentuale della lattato deidrogenasi (LDH)
    7. Variazione dell'affaticamento misurata dalla scala di valutazione funzionale della terapia per malattie croniche- Affaticamento (FACIT-Fatigue)
    8. Variazione nei punteggi della funzionalità fisica (PF) nel questionario sulla qualità della vita a 30 voci dell’organizzazione europea per la ricerca e la cura del cancro (EORTC QLQ-C30)
    9. Variazione nella scala GHS/QOL ([quality of life], qualità della vita) sull’EORTC QLQ-C30
    10. Normalizzazione di LDH
    11. Tasso di trasfusione di globuli rossi (RBC)
    12. Numero di unità di trasfusione di globuli rossi (RBC)
    13. Percentuale di giorni con LDH <=1,5 volte x limite superiore della norma (ULN)
    14. Variazione dei livelli di emoglobina
    15. Variazione nel test dell’attività emolitica totale del complemento (CH50)
    16. Variazione percentuale in CH50
    17. Concentrazioni totali di pozelimab nel siero
    18. Concentrazioni di cemdisiran nel plasma
    19. Incidenza di anticorpi anti-farmaco emergenti dal trattamento contro pozelimab
    20.Incidenza di anticorpi anti-farmaco emergenti dal trattamento contro cemdisiran
    21. Concentrazione di C5 totale nel plasma
    22. Variazione percentuale della concentrazione del C5 totale nel plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Post-baseline through week 48, 76, 108
    2, 10: Post-baseline through week 108
    3-5, 11-13: Post-baseline through week 36, 48, 76, 108
    6-9, 14: From baseline to week 36, 48, 76, 108
    15-17, 19-22: Through week 108
    18: Through week 24
    1: post-basale fino alla settimana 48, 76, 108
    2, 10: post-basale fino alla settimana 108
    3-5, 11-13: post-basale fino alla settimana 36, 48, 76, 108
    6-9, 14: dal basale alla settimana 36, 48, 76, 108
    15-17, 19-22: fino alla settimana 108
    18: Fino alla settimana 24
    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 Yes
    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 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 trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Brazil
    Canada
    China
    Colombia
    India
    Japan
    Jordan
    Korea, Democratic People's Republic of
    Malaysia
    Mexico
    Peru
    Philippines
    Singapore
    South Africa
    Thailand
    United States
    France
    Poland
    Romania
    Spain
    Germany
    Greece
    Italy
    Hungary
    Turkey
    United Kingdom
    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
    The end of study is defined as the date the last patient completes the last study visit, withdraws from the study, or is lost to follow-up (ie, the study patient can no longer be contacted by the investigator)
    La fine dello studio è definita come la data in cui l'ultimo paziente completa l'ultima visita dello studio, si ritira dallo studio o perde il follow-up (ovvero, il paziente dello studio non può più essere contattato dallo sperimentatore)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    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: 242
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 288
    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 Decision2022-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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