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    Summary
    EudraCT Number:2020-000699-39
    Sponsor's Protocol Code Number:FGCL-3019-094
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 number2020-000699-39
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Ambulatory Subjects with Duchenne Muscular Dystrophy (DMD)
    Sperimentazione di Fase 3, randomizzata, in doppio cieco su pamrevlumab (FG-3019) o placebo in combinazione con corticosteroidi sistemici in soggetti deambulanti affetti da distrofia muscolare di Duchenne (DMD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Pamrevlumab for the Treatment of Ambulatory Patients Affected by Duchenne Muscular Dystrophy and just Treated with Corticosteroids
    Valutazione di Pamrevlumab per il trattamento di pazienti deambulanti affetti da distrofia muscolare di Duchenne e trattati solo con corticosteroidi
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberFGCL-3019-094
    A.5.4Other Identifiers
    Name:IND (US)Number:126630
    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 SponsorFIBROGEN
    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 supportFibroGen, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFibroGen, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address409 Illinois Street
    B.5.3.2Town/ citySan Francisco
    B.5.3.3Post code94158
    B.5.3.4CountryUnited States
    B.5.6E-mailFG3019_094@Fibrogen.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2234
    D.3 Description of the IMP
    D.3.1Product namePamrevlumab
    D.3.2Product code [FG-3019]
    D.3.4Pharmaceutical form Solution for 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 INNPAMREVLUMAB
    D.3.9.1CAS number 946415-13-0
    D.3.9.2Current sponsor codeFG-3019
    D.3.9.4EV Substance CodeSUB198085
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for 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
    Ambulatory Duchenne Muscular Dystrophy
    Distrofia muscolare di Duchenne deambulanti
    E.1.1.1Medical condition in easily understood language
    Duchenne Muscle Dystrophy
    Distrofia muscolare di Duchenne
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10013801
    E.1.2Term Duchenne muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids administered every two weeks in ambulatory subjects with Duchenne muscular dystrophy (age 6 to 11 years).
    Valutare l’efficacia e la sicurezza di pamrevlumab rispetto al placebo in combinazione con corticosteroidi sistemici somministrati ogni due settimane in soggetti affetti da distrofia muscolare di Duchenne deambulanti (di età compresa fra 6 e 11 anni).
    E.2.2Secondary objectives of the trial
    Not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Double-blind phase:
    Age and Consent
    1. Males at least 6 to < 12 years of age at screening initiation;
    2. Written consent by legal guardian as per regional/ country and/or IRB/IEC requirements;

    DMD Diagnosis:
    3. Medical history includes diagnosis of DMD and confirmed Duchenne mutation using a validated genetic test.

    Pulmonary Criteria:
    4. Average (of Screening and Day 0) percent predicted FVC above 45%;
    5. On a stable dose of systemic corticosteroids for a minimum of 6 months, with no substantial change in dosage for a minimum of 3 months (except for adjustments for changes in body weight) prior to screening. Corticosteroid dosage should be in compliance with the DMD Care Considerations Working Group recommendations (e.g. prednisone or prednisolone 0.75 mg/kg per day or deflazacort 0.9 mg/kg per day) orstable dose. A reasonable expectation is that dosage and dosing regimen would not change significantly for the duration of the study.

    Performance Criteria:
    6. Able to complte 6MWD test with a distance of at least 270M but no more than 450M on two occasions within 3 months prior to Randomisation with <=10% variation between these two tests.
    7. Able to rise (TTSTAND) from floor in <10 seconds (without aids/orthoses) at screening visit.
    8. Able to undergo MRI test for the lower extremities vastus lateralis muscle.

    Vaccination:
    9. Received pneumococcal vaccine (PPSV23) (or any other pneumococcal polysaccharidevaccine as per national recommendations) and is receiving annual influenza vaccinations.

    Laboratory Criteria:
    10. Adequate renal function: cystatin C <=1.4 mg/L;
    11. Adequate hematology and electrolytes parameters:
    a. Platelets >100,000/mcL
    b. Hemoglobin >12 g/dL
    c. Absolute neutrophil count >1500 /µL
    d. Serum calcium (Ca), potassium (K), sodium (Na), magnesium (Mg) and phosphorus(P) levels are within a clinically accepted range;
    12. Adequate hepatic function:
    a. No history or evidence of liver disease
    b. Gamma glutamyl transferase (GGT) <=3x upper limit of normal (ULN)
    c. Total bilirubin <=1.5xULN.

    Open-label extension phase:
    All patients must have completed treatment through the primary endpoint and completed the Week 52 visit on the double-blind phase. The study investigator must consider the subject medically stable for continued treatment. Written consent/assent by the patients and/or their legal guardian must be obtained prior to the patient’s participation in the open-label extension phase.
    Fase in doppio cieco:
    Età e consenso:
    1. Soggetti di sesso maschile di età compresa fra 6 e <12 anni all’avvio dello screening
    2. Consenso per iscritto da parte del tutore legale in base ai requisiti regionali/nazionali e/o del CE

    Diagnosi di DMD:
    3. L’anamnesi include diagnosi di DMD e mutazione di Duchenne confermata utilizzando un test genetico.

    Criteri polmonari:
    4. Percentuale media della FVC prevista (dello screening e del Giorno 0) superiore al 45%
    5. Con una dose stabile di corticosteroidi sistemici per un minimo di 6 mesi, senza una modifica sostanziale del dosaggio per un minimo di 3 mesi (fatta eccezione per gli aggiustamenti per le variazioni nel peso corporeo) prima dello screening. Il dosaggio di corticosteroidi deve essere conforme alle raccomandazioni del DMD Care Considerations Working Group (per es., prednisone o prednisolone 0,75 mg/kg al giorno o deflazacort 0,9 mg/kg al giorno) o dose stabile. Si ha una ragionevole aspettativa che il dosaggio e il regime di dosaggio non cambino significativamente per tutta la durata dello studio.

    Criteri della prestazione:
    6. Capacità di completare il test 6MWD con una distanza di almeno 270 m ma non superiore a 450 m in due occasioni nei 3 mesi precedenti alla randomizzazione con variazione :S10% tra questi due test.
    7. Capacità di alzarsi (TTSTAND) dal pavimento in <10 secondi (senza ausili/ortosi) alla visita di screening.
    8. Capacità di sottoporsi a un esame RM del muscolo vasto laterale delle estremità inferiori.

    Vaccinazione:
    9. Precedente somministrazione del vaccino anti-pneumococco (PPSV23) (o qualsiasi altro vaccino polisaccaridico anti-pneumococco secondo le raccomandazioni nazionali) e attuale somministrazione delle vaccinazioni antinfluenzali annuali.

    Criteri di laboratorio:
    10. Adeguata funzionalità renale: cistatina C : <=1,4 mg/l
    11. Adeguati parametri di ematologia ed elettroliti:
    a. Piastrine >100.000/mcl
    b. Emoglobina >12 g/dl
    c. Conta assoluta dei neutrofili >1500/µl
    d. I livelli sierici di calcio (Ca), potassio (K), sodio (Na), magnesio (Mg) e fosforo (P) rientrano nell’intervallo clinicamente accettabile
    12. Funzione epatica adeguata:
    b. Gamma-glutamil transferasi (GGT) : <=3 volte il limite superiore della norma (ULN)
    c. Bilirubina totale :<=1,5xULN
    Fase di estensione in aperto:
    Tutti i pazienti devono aver completato il trattamento attraverso l'endpoint primario e completato la visita della settimana 52 della fase in doppio cieco. Lo sperimentatore dello studio deve considerare il soggetto stabile da un punto di vista medico per fargli continuare il trattamento. Deve essere raccolto un consenso/assenso scritto del paziente e/o del suo tutore legale prima che il paziente possa partecipare alla fase di estensione in aperto.
    E.4Principal exclusion criteria
    Both phases:
    General criteria:
    1. Concurrent illness other than DMD that can cause muscle weakness and/or impairment of motor function.
    2. Severe intellectual impairment (eg. severe autism, sever cognitive impairment, severe behavioral disturbance) preventing the ability to perform study assessments in the investigator´s judgement.
    3. Previous exposure to pamrevlumab.
    4. BMI >=40 kg/m2 or weight >117 kg.
    5. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
    6. Exposure to any investigational drug (for DMD or not), in the 30 days prior to screening initiation or use of approved DMD therapies (e.g., eteplirsen, ataluren) within 5 half-lives of screening, whichever is longer, with the exception of the systemic corticosteroids, including deflazacort.

    Cardiac and Pulmonary Criteria:
    7. Requires >= 16 hours continuous ventilation.
    8. Poorly controlled asthma or underlying lung disease such as bronchitis, bronchiectasis, emphysema, recurrent pneumonia that in the opinion of the investigator might impact respiratory function.
    9. Hospitalization due to respiratory failure within 8 weeks prior to screening.
    10. Severe uncontrolled heart failure (NYHA Classes III-IV), including any of the following:
    a. Need for intravenous diuretics or inotropic support within 8 weeks prior to screening
    b. Hospitalization for a heart failure exacerbation or arrhythmia within 8 weeks prior to screening.
    11. Arrhythmia requiring anti-arrhythmic therapy.
    12. Any other evidence of clinically significant structural or functional heart abnormality.

    Clinical Judgments:
    13. The Investigator judges that the subject will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, or any other relevant medical, surgical or psychiatric conditions.
    Entrambe le fasi:
    Criteri generali:
    1. Malattia concomitante diversa da DMD che possa causare debolezza muscolare e/o compromissione della funzione motoria
    2. Grave compromissione intellettuale (per es., autismo grave, grave compromissione cognitiva, gravi disturbi comportamentali) che impediscono di eseguire le valutazioni dello studio a giudizio dello sperimentatore
    3. Precedente esposizione a pamrevlumab
    4. IMC >=40 kg/m2 o peso >117 kg
    5. Anamnesi di reazione allergica o anafilattica agli anticorpi monoclonali murini, chimerici, umanizzati o umani
    6. Esposizione a qualsiasi farmaco sperimentale (per la DMD o meno) nei 30 giorni che precedono l’inizio dello screening o uso di terapie DMD approvate (per es. eteplirina, ataluren) entro 5 emivite dallo screening, a seconda di quale sia il periodo più lungo ad eccezione dei corticosteroidi sistemici, compreso il deflazacort
    Criteri polmonari e cardiaci:
    7. Necessità di >=16 ore di ventilazione continua
    8. Asma scarsamente controllata o malattia polmonare di base quali bronchite, bronchiettasia, enfisema, polmonite ricorrente che, a giudizio dello sperimentatore, potrebbe avere un impatto sulla funzione respiratoria
    9. Ricovero in ospedale a causa di insufficienza respiratoria entro le 8 settimane dallo screening
    10. Grave insufficienza cardiaca non controllata (classi NYHA III-IV), inclusa una qualsiasi delle seguenti condizioni:
    a. Necessità di diuretici per via endovenosa o supporto inotropico entro 8 settimane dallo screening
    b. Ricovero in ospedale per una riacutizzazione dell’insufficienza cardiaca o aritmia nelle 8 settimane precedenti allo screening
    11. Aritmia che richieda una terapia antiaritmica
    12. Qualsiasi altra evidenza di anomalia cardiaca strutturale o funzionale clinicamente significativa
    Giudizio clinico:
    13. Lo sperimentatore ritiene che il soggetto non sarà in grado di partecipare completamente allo studio e di completarlo per qualsiasi motivo, incluse l’incapacità di attenersi alle procedure dello studio e al trattamento, o qualsiasi altra condizione medica, chirurgica o psichiatrica pertinente
    E.5 End points
    E.5.1Primary end point(s)
    Double-blind phase:
    Ambulatory functional assessment:
    • Change in NorthStar Ambulatory Assessment (NSAA) Linearized total score

    Open label phase:
    • Annual mean change in NorthStar Ambulatory Assessment (NSAA) Linerized total score;
    • Annual mean change in 4-stair climb Velocity (4SCV) assessment;
    • Annual mean change in the 10-meter walk/run test;
    • Annual mean change in Time to Stand (TTSTAND);
    • annual mean change of the time of Loss of Ambulation (LoA) assessment.
    Fase in doppio cieco:
    Valutazione funzionale della deambulazione:
    • Variazione del punteggio totale linearizzato della Valutazione ambulatoriale NorthStar (NSAA)

    Fase in aperto:
    • Variazione media annuale totale del punteggio linearizzato della Valutazione ambulatoriale NorthStar (NSAA)
    • Variazione media annuale nella valutazione della velocità di salita di 4 gradini (4SCV)
    • Variazione media annuale del test di camminata/corsa di 10 metri
    • Variazione media annuale del tempo di alzata (TTSTAND)
    • Variazione media annuale del Tempo alla perdita di deambulazione (LoA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Double-blind phase:
    Change in NorthStar Ambulatory Assessment (NSAA) Linearized total score. Baseline, Week 52

    Open label phase:
    • Annual mean change in NorthStar Ambulatory Assessment (NSAA) Linerised total score;
    • Annual mean change in 4-stair climb Velocity (4SCV) assessment;
    • Annual mean change in the 10-meter walk/run test;
    • Annual mean change in Time to Stand (TTSTAND);
    • annual mean change of the time of Loss of Ambulation (LoA) assessment.
    Fase in doppio cieco:
    • Variazione del punteggio totale linearizzato della Valutazione ambulatoriale NorthStar (NSAA) dal basale alla Settimana 52.

    Fase in aperto:
    • Variazione media annuale totale del punteggio linearizzato della Valutazione ambulatoriale NorthStar (NSAA)
    • Variazione media annuale nella valutazione della velocità di salita di 4 gradini (4SCV)
    • Variazione media annuale del test di camminata/corsa di 10 metri
    • Variazioni media annuale del tempo di alzata (TTSTAND)
    • Variazione media annuale del Tempo alla perdita di deambulazione (LoA)
    E.5.2Secondary end point(s)
    Double-blind phase:
    • Change in 4-stair climb Velocity (4SCV) assessment;
    • Change in the 10-meter walk/run test;
    • Change in Time to Stand (TTSTAND);
    • Time to Loss of Ambulation (LoA).
    Fase in doppio cieco:
    • Variazione nella valutazione della velocità di salita di 4 gradini (4SCV)
    • Variazione del test di camminata/corsa di 10 metri
    • Variazioni del tempo di alzata (TTSTAND)
    • Variazione del Tempo alla perdita di deambulazione (LoA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Double-blind phase:
    • Change in 4-stair climb Velocity (4SCV) assessment: Baseline, week 52
    • Change in the 10-meter walk/run test: Baseline, week 52
    • Change in Time to Stand (TTSTAND): Baseline, week 52
    • Time to Loss of Ambulation (LoA): Baseline, week 52
    Fase in doppio cieco:
    • Variazione nella valutazione della velocità di salita di 4 gradini (4SCV), settimana 52
    • Variazione del test di camminata/corsa di 10 metri, settimana 52
    • Variazioni del tempo di alzata (TTSTAND), settimana 52
    • Variazione del Tempo alla perdita di deambulazione (LoA), settimana 52
    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 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 Yes
    E.8.1.7.1Other trial design description
    estensione in aperto
    open label extension
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Canada
    United States
    Austria
    Belgium
    France
    Italy
    Netherlands
    Spain
    Switzerland
    United Kingdom
    Czechia
    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
    Ultima Visita dell'ultimo paziente (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 70
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors
    Minori
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 70
    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 Decision2021-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-10-11
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