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    Summary
    EudraCT Number:2021-000520-35
    Sponsor's Protocol Code Number:ASSTBS-FARM-ONC-MERIDIAN-2020
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    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 number2021-000520-35
    A.3Full title of the trial
    Multiparametric assessment of bone response in mCRPC patients treated with Cabozantinib upon progression to chemotherapy and next generation hormonal agents: a phase II study
    VALUTAZIONE MULTIPARAMETRICA DELLA RISPOSTA OSSEA A CABOZANTINIB IN PAZIENTI CON METASTASI OSSEE DA CARCINOMA PROSTATICO RESISTENTE ALLA CASTRAZIONE IN PROGRESSIONE ALLA CHEMIOTERAPIA E ALLA TERAPIA ORMONALE DI NUOVA GENERAZIONE: UNO STUDIO DI FASE II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multiparametric assessment of bone response in mCRPC patients treated with Cabozantinib upon progression to chemotherapy and next generation hormonal agents
    VALUTAZIONE MULTIPARAMETRICA DELLA RISPOSTA OSSEA A CABOZANTINIB IN PAZIENTI CON METASTASI OSSEE DA CARCINOMA PROSTATICO RESISTENTE ALLA CASTRAZIONE IN PROGRESSIONE ALLA CHEMIOTERAPIA E ALLA TERAPIA ORMONALE DI NUOVA GENERAZIONE
    A.3.2Name or abbreviated title of the trial where available
    MERIDIAN
    MERIDIAN
    A.4.1Sponsor's protocol code numberASSTBS-FARM-ONC-MERIDIAN-2020
    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 SponsorAZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIPSEN S.P.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationazienda socio sanitaria territoriale degli spedali civili di brescia
    B.5.2Functional name of contact pointprogettazione ricerca e studi di fa
    B.5.3 Address:
    B.5.3.1Street Addressp.le spedali Civili 1
    B.5.3.2Town/ cityBrescia
    B.5.3.3Post code25123
    B.5.3.4CountryItaly
    B.5.4Telephone number0303998470
    B.5.6E-mailcoordinamento.ricerca@asst-spedalicivili.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name CABOMETYX - 20 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCABOMETYX
    D.3.2Product code [CABOMETYX]
    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 INNcabozantinib
    D.3.9.2Current sponsor codecabozantinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    PATIENTS WITH BONE METASTASIS FROM PROSTATIC CARCINOMA
    PAZIENTI CON METASTASI OSSEE DA CARCINOMA PROSTATICO
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH BONE METASTASIS FROM PROSTATIC CARCINOMA
    PAZIENTI CON METASTASI OSSEE DA CARCINOMA PROSTATICO
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of bone response to Cabozantinib treatment through WB-DW-MRI.
    Valutazione dell’attività di Cabozantinib in termini di risposta ossea valutata con Whole body diffusion MRI
    E.2.2Secondary objectives of the trial
    Changes in:
    ¿ BMD and TBS through DXA scan
    bone metabolism markers: CTX, bone alkaline phosphatase
    bone pain with validated pain questionnaires (Brief Pain Inventory)
    SRE and Quality of Life evaluation (FACT-P questionnaire)
    uptake at bone scan
    body composition: FBM, LBM through DXA scan
    Correlation between:
    disease response with DW-MRI and bone scan changes
    disease response with DW-MRI and bone pain variation
    changes in bone mineral density and TBS
    changes in either bone mineral density or TBS and markers of bone metabolism
    Modificazione dei markers di metabolismo osseo (CTX, bALP)
    Valutazione delle modificazioni della BMD, del TBS, della massa grassa e della massa magra misurate mediante DEXA scan
    Modificazioni nel dolore osseo (mediante questionario Brief Pain Inventory – Short Form)
    Valutazione degli eventi scheletrici correlati (SRE)
    Modificazioni nella qualità di vita (mediante questionario FACT-P)
    Modificazioni nella risposta alla scintigrafia ossea
    Correlazione tra:
    Risposta di malattia alla WB-DW-MRI e risposta alla scintigrafia
    Risposta di malattia alla WB-DW-MRI e variazioni del dolore
    Variazioni in BMD e in TBS
    Variazioni in BMD/TBS e markers di metabolismo osseo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological diagnosis of prostate carcinoma,
    2. Age > 18 years,
    3. Metastatic disease documented as the presence of bone lesions on bone scan associated or not to soft tissue lesions measurable at CT/RMN,
    4. Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
    5. Expected life expectancy = 3 months,
    6. Patients who have already received docetaxel, cabazitaxel and at least one next generation hormonal agent (abiraterone or enzalutamide) for metastatic disease (either hormone sensitive or castration resistant),
    7. Subject capable to swallow the Study's medication and to comply with the Study's requirements,
    8. Fertile patients and their partners must agree to use methods of contraception.
    9. Signed informed consent.
    Diagnosi istologica di carcinoma prostatico
    2. Età >18 anni
    3. Malattia metastatica documentata come presenza di lesioni ossee alla scintigrafia ossea associate o meno a lesioni ai tessuti molli misurabili alla TC/RMN
    4. Eastern Cooperative Oncology Group (ECOG) performance status non superiore a 2
    5. Aspettativa di vita stimata = 3 mesi
    6. Soggetti che hanno già ricevuto docetaxel, cabazitaxel e almeno un agente ormonale di nuova generazione (sia per la malattia ormono-sensibile che per la malattia resistente alla castrazione)
    7. Soggetto in grado di inghiottire il farmaco in studio e di attenersi ai requisiti previsti dallo studio
    8. I pazienti fertili e i loro partners devono accettare l’utilizzo di metodi contraccettivi
    9. Consenso informato scritto firmato
    E.4Principal exclusion criteria
    Presence of active serious disease, active infection or co-comorbidity that may prevent the study enrollment make
    2. Known or suspected brain metastases or active leptomeningeal dissemination,
    3. History of other malignant neoplasm during the previous 5 years, different from the non-melanoma skin carcinoma,
    4. Absolute Neutrophil Count (ANC) < 1.500/µL, platelet < 100.000/µL, or hemoglobin < 5,6 mmol/L (< 9 g/dL) at Screening Visit (notably: patients must not receive neither any growth factor during the previous 7 days nor any blood transfusion during the 28 days preceding the hematology sampling performed at Screening),
    5. Total bilirubin > 1,5 x ULN at Screening Visit,
    6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2,5 x ULN at Screening Visit,
    7. Creatinine > 177 µmol/L (> 2 mg/dL) at Screening Visit,
    8. Albumin = 30 g/L (= 3,0 g/dL) at Screening Visit,
    9. Alkaline Phosphatase = 5 x ULN,
    10. Prothrombin time / international normalized ratio (PT/INR) or partial thromboplastin time (PTT) test = 1.3 x the laboratory ULN,
    11. Urine protein-to-creatinine ratio (UPCR) > 1 mg/mg (or 113.0 mg/mmol) or proteinuria > 1 g/24 h,
    12. History of seizures or any other seizure-predisposed pathology; history of loss of consciousness or transitory ischaemic attack during the 12 months preceding the Screening visit,
    13. Clinically significant cardiovascular disease including
    - Myocardial infarction - Uncontrolled angina - Congestive heart failure New York Heart Association (NYHA) class 3 or 4, congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is = 45%,- History of clinically significant ventricular arrhythmias
    - History of long QT syndrome or corrected QT interval calculated by the Fridericia formula > 500 msec at Screening Visit,
    - History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place,
    - Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the Screening visit,
    - Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG,
    - Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit,
    14. Gastrointestinal disorder affecting absorption
    15. Major surgery within 4 weeks of enrollment
    16. Concomitant therapy with anticoagulants
    ,17. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment
    18. Bone antiresorptive drugs that are started within 4 weeks of enrollment Bone antiresorptive drugs are permitted if already ongoing before this time point. Patients will be stratified according to zoledronic acid/denosumab exposure.
    19. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment or radiotherapy on sites other than bone administrated within 4 weeks of enrollment (Day 1 Visit). Radiotherapy on bone administrated within 2 weeks of enrollment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. Radiotherapy given with palliative intent will be permitted during study treatment.
    20. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
    1. Presenza di patologia grave in atto, infezione attiva o comorbilità che, a giudizio dello sperimentatore, possa rendere il paziente non arruolabile nello studio
    2. Metastasi cerebrale nota o sospetta, o patologia leptomeningea attiva
    3. Storia di altra neoplasia maligna nei precedenti 5 anni, diversa dal carcinoma cutaneo non-melanoma
    4. Valore assoluto dei neutrofili (ANC) < 1.500/µL, piastrine < 100,000/µL, oppure emoglobina < 5,6 mmol/L (<9 g/dL) alla visita di Screening
    5. Bilirubina totale >1.5 x ULN alla visita di Screening
    6. Alanina aminotransferasi (ALT) oppure aspartato aminotransferasi (AST) > 2,5 x ULN alla visita di Screening
    7. Creatinina > 177 µmol/L (> 2 mg/dL) alla visita di Screening
    8. Albumina = 30 g/L (= 3.0 g/dL) alla visita di Screening
    9. Fosfatasi Alcalina =5 x ULN alla visita di Screening
    10. Tempo di protrombina / international normalized ratio (PT/INR) o tempo di tromboplastina parziale attivata =1.3 x ULN
    11. Rapporto proteine/creatinina nelle urine (UPCR) >1 mg/ml (o 113.0 mg/mmol) o proteinuria >1 g/24h
    12. Storia di convulsioni o di qualsiasi patologia predisponente alle convulsioni; storia di perdita di coscienza o attacco ischemico transitorio nei 12 mesi precedenti lo Screening
    13. Patologia cardiovascolare clinicamente significativa, fra cui:
    - Infarto del miocardio nei sei mesi precedenti lo Screening
    - Angina non controllata nei tre mesi precedenti lo Screening
    - Scompenso cardiaco congestizio, classe NYHA 3 o 4, o storia di scompenso cardiaco congestizio di classe NYHA 3 o 4 in passato, eccetto nel caso di frazione di eiezione ventricolare sinistra = 45% rilevata mediante ecocardiogramma o acquisizione gated MUGA di controllo eseguiti nei 3 mesi precedenti
    - Storia di aritmia ventricolare clinicamente significativa (es., tachicardia ventricolare, fibrillazione ventricolare, torsione di punta)
    - Storia di sindrome del QT lungo o QTc >500 msec calcolato con la formula di Fridericia alla visita di Screening
    - Storia di blocco atrioventricolare Mobitz 2 di secondo o terzo grado
    in paziente non portatore di pace-maker permanente
    - Bradicardia definita da battito cardiaco < 45 bpm rilevata mediante elettrocardiogramma o esame obiettivo allo Screening
    - Ipertensione non controllata definita come pressione arteriosa sistolica a riposo > 170 mmHg oppure pressione arteriosa diastolica > 105 mm Hg allo Screening
    14. Patologie gastrointestinali che influenzano l’assorbimento
    15. Intervento chirurgico rilevante nelle 4 settimane precedenti l’inizio del trattamento con il farmaco sperimentale
    16. Terapia concomitante con anticoagulanti come warfarin o agenti correlati, inibitori della trombina o del fattore Xa, o agenti antiaggreganti . L’eparina a basso peso molecolare (EBPM) e l’aspirina a basso dosaggio a fini cardioprotettivi sono consentite
    17. Utilizzo di prodotti erboristici che potrebbero avere un'attività ormonale verso il carcinoma della prostata e/o un decremento dei valori di PSA () o di corticosteroidi sistemici per un dosaggio superiore all'equivalenza di prednisone 10 mg al dì nelle 4 settimane precedenti all'inizio del trattamento)Terapia sistemica con radionuclidi eseguita nelle 6 settimane precedenti all’avvio del trattamento, o radioterapia eseguita su siti non ossei nelle 4 settimane precedenti all’inizio del trattamento . Radioterapia sulle lesioni ossee somministrata nelle 2 settimane precedenti all’avvio del trattamento. Soggetti con complicanze rilevanti e non risolte dovute ad un precedente trattamento radiante non possono essere arruolati. La radioterapia a fini palliativi è consentita nel corso del periodo di studio.
    19. Qualsiasi condizione che a giudizio dello sperimentatore renderebbe il soggetto non idoneo a partecipare allo studio, che mette il paziente a rischio eccessivo, o complica l'interpretazione di dati sicuri
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of bone response to Cabozantinib treatment through WB-DW-MRI.
    Valutazione dell’attività di Cabozantinib in termini di risposta ossea valutata con Whole body diffusion MRI
    E.5.1.1Timepoint(s) of evaluation of this end point
    2-3-6-12- Month
    2-3-6-12- mesi
    E.5.2Secondary end point(s)
    Changes in:
    BMD and TBS through DXA scan
    bone metabolism markers: CTX, bone alkaline phosphatase
    bone pain with validated pain questionnaires (Brief Pain Inventory)
    SRE and Quality of Life evaluation (FACT-P questionnaire)
    uptake at bone scan
    body composition: FBM, LBM through DXA scan; Correlation between:
    disease response with DW-MRI and bone scan changes
    disease response with DW-MRI and bone pain variation
    changes in bone mineral density and TBS
    changes in either bone mineral density or TBS and markers of bone metabolism
    Modificazione dei markers di metabolismo osseo (CTX, bALP)
    ¿ Valutazione delle modificazioni della BMD, del TBS, della massa grassa e della massa magra misurate mediante DEXA scan
    ¿ Modificazioni nel dolore osseo (mediante questionario Brief Pain Inventory – Short Form)
    ¿ Valutazione degli eventi scheletrici correlati (SRE)
    ¿ Modificazioni nella qualità di vita (mediante questionario FACT-P)
    ¿ Modificazioni nella risposta alla scintigrafia ossea; Correlazione tra:
    Risposta di malattia alla WB-DW-MRI e risposta alla scintigrafia
    Risposta di malattia alla WB-DW-MRI e variazioni del dolore
    Variazioni in BMD e in TBS
    Variazioni in BMD/TBS e markers di metabolismo osseo
    E.5.2.1Timepoint(s) of evaluation of this end point
    3-6-12 month; 3-6-12 month
    3-6-12 mesi; 3-6-12 mesi
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    the patients who will benefit from the study drug, the treatment will be guaranteed until disease progression.
    i pazienti che trarranno beneficio dal trattamento sperimentale sarà garantita la continuità del trattamento fino a progressione di malattia.
    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 Decision2021-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-06-04
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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