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    Summary
    EudraCT Number:2020-004176-18
    Sponsor's Protocol Code Number:CHK01-02
    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:2021-06-08
    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 number2020-004176-18
    A.3Full title of the trial
    A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)
    Studio basket di fase 2, in aperto su atrasentan in pazienti affetti da malattie glomerulari proteinuriche (studio AFFINITY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)
    Studio basket di fase 2, in aperto su atrasentan in pazienti affetti da malattie glomerulari proteinuriche (studio AFFINITY)
    A.3.2Name or abbreviated title of the trial where available
    AFFINITY Study
    Studio AFFINITY
    A.4.1Sponsor's protocol code numberCHK01-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04573920
    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 SponsorCHINOOK THERAPEUTICS, U.S., 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 supportChinook Therapeutics U.S., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChinook Therapeutics U.S., Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address100-1600 Fairview Avenue East
    B.5.3.2Town/ citySeattle
    B.5.3.3Post codeWA 98102
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12064857051
    B.5.6E-mailclinicaltrials@chinooktx.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 nameatrasentan
    D.3.2Product code [atrasentan]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNatrasentan
    D.3.9.1CAS number 195733-43-8
    D.3.9.2Current sponsor codeCHK-01
    D.3.9.3Other descriptive nameATRASENTAN
    D.3.9.4EV Substance CodeSUB20598
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Proteinuric glomerular diseases, including:
    Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)
    Focal segmental glomerulosclerosis (FSGS)
    Alport Syndrome
    Diabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors)
    Malattie glomerulari proteinuriche, tra cui:
    Nefropatia da immunoglobulina A (IgAN) (con UPCR da 0,5 a <1,0 g / g)
    Glomerulosclerosi segmentale focale (FSGS)
    Sindrome di Alport
    Diabete renale disease (DKD) (in aggiunta a RAS e inibitori del co-trasportatore di sodio glucosio 2 [SGLT2])
    E.1.1.1Medical condition in easily understood language
    Proteinuric glomerular diseases:
    Immunoglobulin A nephropathy (IgAN)
    Focal segmental glomerulosclerosis (FSGS)
    Alport Syndrome
    Diabetes kidney disease (DKD)
    Malattie glomerulari proteinuriche:
    Nefropatia da immunoglobulina A (IgAN)
    Glomerulosclerosi segmentale focale (FSGS)
    Sindrome di Alport
    Diabete malattia renale (DKD)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of atrasentan on proteinuria/albuminuria levels in subjects at risk of progressive loss of kidney function
    Valutare l'effetto di atrasentan sui livelli di proteinuria / albuminuria in soggetti a rischio di perdita progressiva della funzionalità renale
    E.2.2Secondary objectives of the trial
    Not Applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort 1 – IgAN
    1. Biopsy-proven IgAN that, in the opinion of the Investigator, is not due to secondary causes.
    - Biopsy could have occurred at any point in time prior to study
    - A diagnostic report must be available for review by the Sponsor or designee
    2. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening.
    3. UPCR = 0.5 and < 1.0 g/g (= 500 mg/g and < 1000 mg/g) based on a central laboratory assessment of first morning void urine collected at screening.
    4. eGFR = 30 mL/min/1.73 m2

    Cohort 2 – FSGS
    5. Biopsy-confirmed FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.
    6. UPCR >1.5 g/g (> 1500 mg/g) based on a central laboratory assessment of first morning void urine collected at screening.
    7. eGFR = 30 mL/min/1.73 m2
    8. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening.
    9. If receiving systemic corticosteroids or calcineurin inhibitors, dose must be stable for 12 weeks prior to start of study drug and anticipated to remain on a stable dose at least through week 12.
    10. Body mass index (BMI) = 40 kg/m2

    Cohort 3 – Alport syndrome
    11. Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome, including COL4A3, COL4A4, or X-linked COL4A5 in the subject or a family member). Or patients with a new mutation, that, in the opinion of the Investigator, has significant supporting evidence of Alport syndrome (biopsy, familial genetics, family history & familial biopsy, microscopic hematuria, hearing loss pattern, fleck retinopathy).
    12. UPCR > 0.5 g/g (>500 mg/g) based on central laboratory assessment of first morning void urine at screening
    13. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening visit
    14. eGFR = 30 mL/min/1.73 m2

    Cohort 4 – DKD
    15. Clinical diagnosis of type 2 diabetes mellitus (T2DM) as per guidelines
    16. Diagnosis of DKD, including the presence of the following criteria:
    a. UACR = 0.5 g/g (500 mg/g) based on central laboratory assessment of first morning void urine at screening
    b. eGFR = 30 mL/min/1.73 m2
    17. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to the screening visit and stable dose of SGLT2 inhibitor for at least 12 weeks prior to screening
    Age
    18. Age 18 years and older at the time of signing ICF
    Pregnancy and Contraception
    19. Willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the study and for 1 month afterward. In WOCBP, use of hormonal contraceptive agents must have been started at least 1 month prior to baseline.
    Informed Consent
    20. Willing and able to provide written informed consent and comply with all study visits and study procedures.
    Coorte 1 - IgAN
    1. IgAN comprovata dalla biopsia che, a giudizio dello sperimentatore, non è dovuta a cause secondarie.
    • La biopsia potrebbe essere stata eseguita in qualsiasi momento prima dello studio.
    • Deve essere disponibile un referto diagnostico per la revisione da parte dello sponsor o del suo designato.
    2. Somministrazione di una dose massima tollerata e ottimizzata di un inibitore del RAS stabile per almeno 12 settimane prima dello screening.
    3. UPCR =0,5 e <1,0 g/g (=500 mg/g e <1000 mg/g) in base a una valutazione del laboratorio centralizzato delle urine del primo mattino raccolte allo screening.
    4. eGFR =30 ml/min/1,73 m2
    Coorte 2 - FSGS
    5. FSGS primaria confermata da biopsia o documentazione di una mutazione genetica in una proteina podocitica associata alla FSGS.
    6. UPCR >1,5 g/g (>1.500 mg/g) in base a una valutazione da parte del laboratorio centralizzato delle urine del primo mattino raccolte allo screening.
    7. eGFR =30 ml/min/1,73 m2
    8. Somministrazione di una dose massima tollerata e ottimizzata di un inibitore del RAS stabile per almeno 12 settimane prima dello screening.
    9. In caso di terapia con corticosteroidi sistemici o inibitori della calcineurina, la dose deve essere stabile per 12 settimane prima dell’inizio del farmaco dello studio e si deve prevedere di mantenere l’assunzione di una dose stabile almeno fino alla Settimana 12.
    10. Indice di massa corporea (IMC) =40 kg/m2
    Coorte 3 - Sindrome di Alport
    11. Diagnosi di sindrome di Alport comprovata da analisi genetica (mutazione documentata in un gene associato alla sindrome di Alport, compresi COL4A3, COL4A4 o COL4A5 legato al cromosoma X nel soggetto o in un suo familiare) o una nuova mutazione con significativa evidenza a supporto di sindrome di Alport (biopsia, genetica familiare, anamnesi familiare e biopsia familiare, pattern di perdita dell’udito, retinopatia a chiazze)
    12. UPCR >0,5 g/g (>500 mg/g) in base a una valutazione da parte del laboratorio centralizzato delle urine del primo mattino raccolte allo screening
    13. Somministrazione di una dose massima tollerata e ottimizzata di un inibitore del RAS stabile per almeno 12 settimane prima della visita di screening
    14. eGFR =30 ml/min/1,73 m2
    Coorte 4 - DKD
    15. Diagnosi clinica di diabete mellito di tipo 2 (T2DM) secondo le linee guida
    16. Diagnosi di DKD, compresa la presenza dei seguenti criteri:
    a. UACR =0,5 g/g (500 mg/g) in base a una valutazione da parte del laboratorio centralizzato delle urine del primo mattino raccolte allo screening
    b. eGFR =30 ml/min/1,73 m2
    17. Somministrazione di una dose massima tollerata e ottimizzata di un inibitore del RAS stabile per almeno 12 settimane prima della visita di screening e di una dose stabile di un inibitore del SGLT2 per almeno 12 settimane prima dello screening
    Età
    18. Età pari o superiore a 18 anni al momento della firma dell’ICF
    Gravidanza e contraccezione
    19. Essere disposto a rispettare forme di contraccezione altamente efficaci, come specificato nel protocollo, per tutta la durata dello studio e per 1 mese dopo. Nelle WOCBP, l’uso di agenti contraccettivi ormonali deve essere iniziato almeno 1 mese prima del basale.
    Consenso informato
    20. Essere disposto e in grado di attenersi alle procedure dello studio e di fornire il consenso informato scritto.
    E.4Principal exclusion criteria
    Medical Conditions
    1. Concurrent diagnosis of another cause of CKD or another primary glomerulopathy. Note: hypertensive nephrosclerosis is not exclusionary
    2. Clinical suspicion of rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines or clinical suspicion of IgA vasculitis (Henoch-Schonlein Purpura).
    3. History of organ transplantation (subjects with history of corneal transplant are not excluded).
    4. Known history of congestive heart failure, diastolic dysfunction, or prior hospital admissions for conditions relating to fluid overload such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites.
    5. Known history of clinically significant liver disease or transaminase or bilirubin values >2 times the upper limit of normal (ULN) for Cohorts 1-3; for Cohort 4 (DKD), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3XULN (subjects with non alcoholic fatty liver disease/non-alcoholic steatohepatitis will be allowed).
    6. Active infection which may warrant systemic treatment
    7. Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies)
    8. Known active Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive); Subjects with successfully treated hepatitis C can be considered for inclusion into the study upon consultation with the Sponsor’s Medical Monitor (or designee).
    9. History of malignancy unless cancer free for at least 5 years or nonmelanoma skin cancer not requiring ongoing treatment. A subject with curatively treated cervical carcinoma in situ is eligible for this study.
    10. Any history within 3 months of screening of clinically significant, unstable, or uncontrolled cardiovascular (including myocardial infarction, unstable angina, cardiovascular revascularization procedure, cerebrovascular accident, or transient ischemic attack), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator or Sponsor’s Medical Monitor (or designee), might confound the results of the study or pose additional risk to the subject by their participation in the study.

    Diagnostic assessments
    11. Brain natriuretic peptide (BNP) value of > 200 pg/mL at screening
    12. Platelet count <80,000 per µL at screening
    13. Hemoglobin below 9 g/dL at screening or prior history of blood transfusion for anemia within 3 months of screening.
    14. Confirmed blood pressure >150 mmHg systolic or >95 mmHg diastolic based on a mean of 3 measurements obtained at screening.
    15. Serum albumin < 3.0 g/dL for patients in the IgAN, Alport Syndrome, and DKD cohorts.
    16. HbA1c > 9.5% in Cohort 4 (DKD), HbA1c > 7.0% in Cohorts 1-3.

    Prior/Concomitant Medications
    17. Except for Cohort 2 (FSGS), use of systemic immunosuppressant medications including systemic steroids (prednisone or equivalent >10 mg/day for more than 2 weeks within 3 months prior to screening), mycophenolate, azathioprine, cyclosporine, tacrolimus, etc. for more than 2 weeks within the past 3 months prior to screening.
    18. Use of rituximab within the past 6 months
    19. Use of mineralocorticoid receptor antagonists such as spironolactone/eplerenone within 3 months prior to screening
    20. With the exception of DKD (Cohort 4), use of an SGLT2 inhibitor within the past 30 days.

    Prior/Concurrent Clinical Study Experience
    21. Have received any investigational agent within 1 month (or 5 half-lives of the agent, whichever is longer) prior to screening. If the investigational agent is a cytotoxic or immunosuppressive agent, then this washout period is 6 months.
    Other Exclusions
    22. History of an alcohol or illicit drug-related disorder within the past 3 years.
    23. Pregnancy, breast feeding, or intent to become pregnant during the study period and at least 1 month afterward for females.
    24. Intent to father a child or donate sperm during the study period and at least 1 month afterward for males.
    Condizioni mediche
    1. Diagnosi concomitante di un’altra causa di malattia renale cronica (CKD) o di un’altra glomerulopatia primaria. Nota: la nefrosclerosi ipertensiva non comporta l’esclusione
    2. Sospetto clinico di glomerulonefrite rapidamente progressiva (RPGN) in base alle linee guida KDIGO o al sospetto clinico di vasculite da IgA (porpora di Henoch-Schonlein).
    3. Anamnesi di trapianto d’organo (i soggetti con anamnesi di trapianto corneale non sono esclusi).
    4. Anamnesi nota di scompenso cardiaco congestizio, disfunzione diastolica o ricoveri ospedalieri precedenti per condizioni relative a sovraccarico di liquidi come edema polmonare, edema periferico non controllato, versamento pleurico o ascite.
    5. Anamnesi nota di malattia epatica clinicamente significativa o valori di transaminasi o bilirubina >2 volte il limite superiore della norma (ULN) per le Coorti 1-3; per la Coorte 4 (DKD), alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) >3¿ULN (saranno ammessi soggetti con steatosi epatica non alcolica/steatoepatite non alcolica).
    6. Infezione attiva che potrebbe richiedere un trattamento sistemico
    7. Nota anamnesi di infezione da virus dell’immunodeficienza umana (HIV; anticorpi anti-HIV 1/2).
    8. Epatite B nota in fase attiva (definita come reattività all’antigene di superficie dell’epatite B [HBsAg]); i soggetti con epatite C trattata con successo possono essere considerati per l’inclusione nello studio previa consultazione con il monitor medico dello sponsor (o un suo designato).
    9. Anamnesi di tumore maligno a meno che non sia libero da tumore da almeno 5 anni o tumore della pelle di tipo non melanoma che non richieda trattamento in corso. Un soggetto con carcinoma cervicale trattato in situ è idoneo per questo studio.
    10. Qualsiasi anamnesi nei 3 mesi precedenti lo screening di malattia cardiovascolare (compresi infarto miocardico, angina instabile, procedura di rivascolarizzazione cardiovascolare, ictus cerebrovascolare o attacco ischemico transitorio), polmonare, epatica, renale, gastrointestinale, genitourinaria, ematologica, coagulativa, immunologica, endocrina/metabolica o altra patologia clinicamente significativa, instabile o non controllata che, a giudizio dello sperimentatore o del monitor medico dello sponsor (o suo designato), potrebbe confondere i risultati dello studio o rappresentare un ulteriore rischio per il soggetto a causa della sua partecipazione allo studio.
    Valutazioni diagnostiche
    11. Valore del peptide natriuretico cerebrale (BNP) >200 pg/ml allo screening.
    12. Conta piastrinica <80.000 per µl allo screening.
    13. Emoglobina inferiore a 9 g/dl allo screening o precedente anamnesi di trasfusione di sangue per l’anemia entro 3 mesi dallo screening.
    14. Pressione sanguigna confermata >150 mmHg sistolica o >95 mmHg diastolica in base a una media di 3 misurazioni ottenute allo screening.
    15. Albumina sierica <3,0 g/dl per i pazienti nelle coorti con IgAN, sindrome di Alport e DKD.
    16. HbA1c >9,5% nella Coorte 4 (DKD), HbA1c >7,0% nelle Coorti 1-3.
    Farmaci pregressi/concomitanti
    17. Fatta eccezione per la Coorte 2 (FSGS), uso di farmaci immunosoppressori sistemici, inclusi steroidi sistemici (prednisone o equivalente >10 mg/giorno per più di 2 settimane nei 3 mesi precedenti lo screening), micofenolato, azatioprina, ciclosporina, tacrolimus, ecc. per più di 2 settimane negli ultimi 3 mesi prima dello screening.
    18. Uso di rituximab negli ultimi 6 mesi.
    19. Uso di antagonisti del recettore dei mineralcorticoidi come spironolattone/eplerenone nei 3 mesi precedenti lo screening.
    20. Ad eccezione della DKD (Coorte 4), uso di un inibitore del SGLT2 nei 30 giorni precedenti.
    Esperienza di studi clinici precedenti/concomitanti
    21. Aver ricevuto qualsiasi agente sperimentale entro 1 mese (o 5 emivite dell’agente, qualunque periodo sia più lungo) prima dello screening. Se l’agente sperimentale è un agente citotossico o immunosoppressivo, questo periodo di washout è di 6 mesi.
    Altre esclusioni.
    E.5 End points
    E.5.1Primary end point(s)
    Cohorts 1-3:
    Change from baseline at Week 12 in UPCR, based on 24 hour urine collection

    Cohort 4:
    Change from baseline at Week 12 in UACR, based on first morning void (FMV) urine collection
    Coorte 1-3:
    Variazione dal basale alla Settimana 12 nell’UPCR (in base alla raccolta di urine delle 24 ore

    Coorte 4:
    Variazione dal basale alla Settimana 12 nel rapporto albumina:creatinina urinarie (UACR), in base alla raccolta di urine della prima minzione mattutina (FMV)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    Dal basale alla settimana 12
    E.5.2Secondary end point(s)
    Not Applicable
    Non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable

    Non applicabile
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Korea, Republic of
    United States
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months32
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months32
    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: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 24
    F.4.2.2In the whole clinical trial 80
    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)
    All subjects will be treated per standard of care by their physicians.
    Tutti i soggetti saranno trattati per le cure standard dai loro medici.
    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 Decision2021-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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