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    Summary
    EudraCT Number:2020-003571-17
    Sponsor's Protocol Code Number:CY6022
    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:2021-09-02
    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 number2020-003571-17
    A.3Full title of the trial
    An Open-Label Study of CK­3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Outflow Tract Obstruction
    Studio in aperto di CK­3773274 per pazienti affetti da cardiomiopatia ipertrofica (HCM) sintomatica e ostruzione al tratto di efflusso ventricolare sinistro
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Study of CK­3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Outflow Tract Obstruction
    Studio in aperto di CK­3773274 per pazienti affetti da cardiomiopatia ipertrofica (HCM) sintomatica e ostruzione al tratto di efflusso ventricolare sinistro
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberCY6022
    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 SponsorCYTOKINETICS, 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 supportCytokinetics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytokinetics Inc
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street Address280 East Grand Avenue
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number16506242929
    B.5.6E-mailmedicalaffairs@cytokinetics.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 namen/a
    D.3.2Product code [CK-3773274]
    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 INNCK-3773274
    D.3.9.2Current sponsor codeCK-3773274
    D.3.9.3Other descriptive name(R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
    D.3.9.4EV Substance CodeSUB197451
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namen/a
    D.3.2Product code [CK-3773274]
    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 INNCK-3773274
    D.3.9.2Current sponsor codeCK-3773274
    D.3.9.3Other descriptive name(R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1HPYRAZOLE-4-CARBOXAMIDE
    D.3.9.4EV Substance CodeSUB197451
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Obstructive Hypertrophic Cardiomyopathy (oHCM)
    Cardiomiopatia Ipertrofica Ostruttiva (oHCM)
    E.1.1.1Medical condition in easily understood language
    Heart disease with thickening of the heart muscle
    Malattia cardiaca con ispessimento del muscolo cardiaco
    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 PT
    E.1.2Classification code 10020871
    E.1.2Term Hypertrophic cardiomyopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of CK-3773274 in patients with symptomatic oHCM
    Determinare la sicurezza e la tollerabilità di CK-3773274 in pazienti con oHCM sintomatico
    E.2.2Secondary objectives of the trial
    To assess long-term effects of CK-3773274 on left ventricular outflow tract gradient (LVOT-G)
    To assess steady-state PK during long-term administration of CK3773274
    Valutare gli effetti a lungo termine di CK-3773274 sul gradiente in tratto di efflusso ventricolare sinistro (LVOT-G)
    Valutare i parametri PK allo stato stazionario durante la somministrazione a lungo termine di CK-3773274
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: A cardiac magnetic resonance (CMR) imaging sub-study will assess the effects of long-term administration of CK-3773274 dosing on cardiac morphology, function and fibrosis in those oHCM patients who are eligible and elect to participate. CMR will be performed at baseline. Patients with eGFR <30 mL/min/1.73 m2 or an allergy to gadolinium may only be given non-contrast CMR.
    Subsequent CMR studies will be performed at the Q12W visit corresponding to Weeks 48, 144 and 240.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Un sottostudio di risonanza magnetica cardiaca (Cardio RM) per immagini valuterà gli effetti della somministrazione a lungo termine del dosaggio CK-3773274 sulla morfologia, la funzione e la fibrosi cardiaca in pazienti oHCM che sono idonei e decidono di partecipare. La Cardio RM sarà eseguita al basale.
    I pazienti con eGFR <30 ml/min/1,73 m2 o un’allergia al gadolinio potranno essere sottoposti solo a Cardio RM senza contrasto. Gli studi Cardio RM successivi saranno condotti alla visita Q12W che corrisponde alle Settimane 48, 144 e 240.
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if all the following criteria apply:
    1. Able to comprehend and willing to sign an ICF and willing to comply with all study procedures and restrictions for the duration specified in the Schedule of Activities.
    2. Completion of a Cytokinetics trial investigating CK-3773274. If unable to complete due to circumstances not related to compliance or safety, Medical Monitor may review and determine eligibility.
    3. Left ventricular ejection fraction = 55%.
    4. Male patients are eligible to participate if they agree to the following during the study and for at least 10 weeks after the last dose of IP:
    a. Refrain from donating sperm
    Plus either:
    b. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
    OR
    Must agree to use a male condom and, when his female partner is a woman of childbearing potential, have his female partner use a highly effective method of contraception (as described in Appendix 3 [Section10.3] of the protocol)
    5. A female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    a. Is not a woman of childbearing potential (WOCBP; as described in Appendix 3 [Section 10.3] of the protocol)
    OR
    Is a WOCBP and using a highly effective method of contraceptive (as described in Appendix 3 [Section 10.3]) during the study and for at least 4 weeks after the last dose of IP.
    b. A WOCBP must have a negative pregnancy test (urine or serum as required by local regulations) within 3 days before the first dose of study
    intervention.
    Note: The Principal Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
    Contraceptive use by men or WOCBPs should be consistent with the guidance in Appendix 3 (Section 10.3) and local regulations regarding the methods of contraception for those participating in clinical studies.
    6. Willing and able to complete all screening procedures.
    I pazienti sono idonei a essere inclusi nello studio solo se soddisfano tutti i seguenti criteri:
    1. Sono in grado di comprendere e disposti a firmare un ICF e a rispettare tutte le procedure e le restrizioni dello studio per la durata indicata nel Programma delle attività.
    2. Hanno completato una sperimentazione Cytokinetics su CK-3773274. In caso di impossibilità a completare per circostanze non correlate alla conformità o alla sicurezza, il Monitor clinico potrà esaminare e determinare l’idoneità.
    3. Frazione di eiezione ventricolare sinistra =55%.
    4. I pazienti di sesso maschile sono idonei a partecipare se accettano le seguenti condizioni durante lo studio e per almeno 10 settimane dopo l’ultima dose dell’IP:
    a. evitare di donare sperma oltre a:
    b. astenersi dai rapporti eterosessuali come stile di vita preferito e abituale (astinenza a lungo termine e persistente) e accettano di proseguire l’astinenza;
    OPPURE
    devono acconsentire a utilizzare un preservativo maschile e, se la partner di sesso femminile è in età fertile, chiedere alla partner di utilizzare un metodo contraccettivo altamente efficace (come descritto nell’Appendice 3 [Sezione 10.3] del protocollo).
    5. Una paziente di sesso femminile è idonea a partecipare se non è in gravidanza né sta allattando con latte materno, e si applica almeno una delle seguenti condizioni:
    a. non è in età fertile (WOCBP, come descritto nell’Appendice 3 [Sezione 10.3] del protocollo);
    OPPURE
    è una WOCBP e utilizza un metodo contraccettivo altamente efficace (come descritto nell’Appendice 3 [Sezione 10.3] del protocollo) durante lo studio e per almeno 4 settimane dopo l’ultima dose dell’IP;
    b. una WOCBP deve avere un test di gravidanza negativo (delle urine o del siero secondo i requisiti locali) entro i 3 giorni precedenti la prima dose del trattamento in studio.
    Nota: lo Sperimentatore principale è responsabile di revisionare l’anamnesi medica, l’anamnesi mestruale e l’attività sessuale recente per ridurre il rischio di includere accidentalmente una donna nelle fasi iniziali della gravidanza.
    L’utilizzo di contraccettivi da parte di uomini o WOCBP deve essere coerente con le indicazioni riportate nell’Appendice 3 (Sezione 10.3) e i regolamenti locali relativi ai metodi contraccettivi per coloro che partecipano agli studi clinici.
    6. Disposti e in grado di completare tutte le procedure di screening.
    E.4Principal exclusion criteria
    - Has taken any investigational study drug other than CK-3773274 within 30 days prior to screening.
    - Since completion of a previous trial of CK-3773274 has:
    1. Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days.
    2. Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
    - Has current obstructive coronary artery disease (>70% stenosis
    documented in one or more arteries).
    - Has moderate or severe aortic valve stenosis.
    - Had a confirmed LVEF <40% with an associated dose interruption during CY 6021. If data from the participant's cohort has been unblinded, the patient may be considered for entry into CY 6022 (see Section 6.6.1 of the protocol).
    - Has been treated with drugs that have negative inotropic activity within 30 days prior to screening.
    - History of syncope or sustained ventricular tachyarrhythmia with exercise within 30 days prior to screening.
    - History of appropriate ICD shock within 30 days prior to screening.
    - Has received treatment with mavacamten within 3 months prior to screening.

    Exclusion Criteria for CMR sub-study:
    - Inability to tolerate CMR.
    - Has an implantable cardioverter-defibrillator (ICD).
    - Has a cardiac pacemaker.
    - Precedente uso di qualsiasi farmaco in studio sperimentale diverso da CK-3773274 nei 30 giorni precedenti lo screening.
    - Dal completamento di una sperimentazione precedente di CK-3773274:
    1. Comparsa di fibrillazione atriale permanente o parossistica di nuova insorgenza che richieda trattamento di ripristino del ritmo cardiaco (es. cardioversione a corrente continua, procedura di ablazione o terapia antiaritmica) <30 giorni prima dello screening. Il/La paziente può essere sottoposto/a nuovamente a screening per CY 6022 dopo 30 giorni se la frequenza cardiaca (FC) è <100 bpm e/o il ritmo è stabile per oltre 30 giorni.
    2. Pazienti sottoposti a terapia di riduzione settale (miectomia chirurgica o ablazione alcolica transcatetere).
    - Presenza di coronaropatia ostruttiva (>70% di stenosi documentata in una o più arterie).
    - Presenza di stenosi della valvola aortica grave o moderata.
    - Anamnesi di LVEF confermata <40% con associata interruzione della dose durante CY 6021. Se i dati dalla coorte del/della partecipante sono stati smascherati, il/la paziente potrà essere considerato/a per entrare nello studio CY 6022 (vedere la Sezione 6.6.1 del protocollo).
    - Trattamento con farmaci aventi un’attività inotropica negativa nei 30 giorni precedenti lo screening.
    - Anamnesi di sincope o tachiaritmia ventricolare sostenuta sotto sforzo nei 30 giorni precedenti lo screening.
    - Anamnesi di erogazione di shock ICD nei 30 giorni precedenti lo screening.
    - Trattamento con mavacamten nei 3 mesi precedenti lo screening.

    Criteri di esclusione per il sottostudio Cardio RM:
    - Incapacità di tollerare la Cardio RM.
    - Presenza di defibrillatore cardioverter impiantabile (ICD).
    - Presenza di pacemaker cardiaco.
    E.5 End points
    E.5.1Primary end point(s)
    - Patient incidence of reported adverse events (AEs)
    - Patient incidence of reported serious adverse events (SAEs)
    - Patient incidence of left ventricular ejection fraction (LVEF) <50%
    - Incidenza degli eventi avversi (EA) riportati per il/la pazient
    - Incidenza degli eventi avversi gravi (EAG) riportati per il/la paziente
    - Incidenza di frazione di eiezione ventricolare sinistra (LVEF) <50% per il/la paziente
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of participation
    Fine della partecipazione
    E.5.2Secondary end point(s)
    1. Change from baseline values at 12-week intervals through end of participation in:
    - Peak LVOT-G at rest and with Valsalva provocation
    - Proportion of patients with resting LVOT-G <50 mmHg
    - Proportion of patients with resting LVOT-G <30 mmHg
    - Proportion of patients with post-Valsalva LVOT-G <50 mmHg
    - Proportion of patients with post-Valsalva LVOT-G <30 mmHg
    - Proportion of patients with LVEF =50%, resting LVOT-G <30 mmHg,
    and post-Valsalva LVOT-G <50 mmHg
    2. Time to the following event through last follow-up
    - First resting LVOT-G <50 mmHg
    - First resting LVOT-G <30 mmHg
    - First post-Valsalva LVOT-G <50 mmHg
    - First post-Valsalva LVOT-G <30 mmHg
    - First LVEF =50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg
    3. C^trough at 12-week intervals through end of participation
    1. Cambiamento dei valori basali a intervalli di 12 settimane fino alla fine della partecipazione relativamente a:
    - LVOT-G di picco a riposo e con manovra di Valsalva
    - Proporzione di pazienti con LVOT-G a riposo <50 mmHg
    - Proporzione di pazienti con LVOT-G a riposo <30 mmHg
    - Proporzione di pazienti con LVOT-G post-Valsalva <50 mmHg
    - Proporzione di pazienti con LVOT-G post-Valsalva <30 mmHg
    - Proporzione di pazienti con LVEF =50%, LVOT-G a riposo <30 mmHG e post-Valsalva <50 mmHg
    2. Tempo all’evento successivo fino all’ultimo follow-up
    - Primo LVOT-G a riposo <50 mmHg
    - Primo LVOT-G a riposo <30 mmHg
    - Primo LVOT-G post-Valsalva <50 mmHg
    - Primo LVOT-G post-Valsalva <30 mmHg
    - Prima LVEF =50%, LVOT-G a riposo <30 mmHG e post-Valsalva <50 mmHg
    3. C^minimo a intervalli di 12 settimane fino alla fine della partecipazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of participation
    Fine della partecipazione
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    United States
    Italy
    Spain
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 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: 36
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2
    F.4.2.2In the whole clinical trial 54
    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)
    N/A
    N/A
    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 Decision2021-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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