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    Summary
    EudraCT Number:2020-002397-27
    Sponsor's Protocol Code Number:MK-2060-007
    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:2022-03-24
    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 number2020-002397-27
    A.3Full title of the trial
    A Randomized Parallel-group, Placebo-controlled, Double-blind, Event-driven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients With End Stage Renal Disease Receiving Hemodialysis
    Studio clinico di fase 2 randomizzato a gruppi paralleli, controllato con
    placebo, in doppio cieco, guidato da eventi, multicentrico, sulla prevenzione della trombosi dell'innesto arterovenoso e sulla sicurezza di MK2060 in soggetti con malattia renale allo stadio terminale che ricevono emodialisi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A global trial to evaluate the efficacy and safety of MK-2060 in patients with end stage renal disease receiving hemodialysis
    Studio globale per valutare l'efficacia e la sicurezza di MK-2060 in pazienti con malattia renale allo stadio terminale sottoposti a emodialisi
    A.3.2Name or abbreviated title of the trial where available
    MK-2060 Global Study in Patients with End Stage Renal Disease Receiving Hemodialysis
    Studio globale su MK-2060 in pazienti con malattia renale allo stadio terminale sottoposti a emodial
    A.4.1Sponsor's protocol code numberMK-2060-007
    A.5.4Other Identifiers
    Name:INDNumber:142237
    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 SponsorMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia Srl
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano, 151
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number+39090636191371
    B.5.5Fax number+390636380371
    B.5.6E-mailgcto.italy@merck.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 nameMK-2060
    D.3.2Product code [MK-2060]
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNMK-2060
    D.3.9.2Current sponsor codeMK-2060
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7500
    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
    Prevention of arteriovenous graft thrombosis in patients with end stage renal disease receiving hemodialysis.
    Prevenzione della trombosi dell'innesto arterovenoso in soggetti con malattia renale allo stadio terminale che ricevono emodialisi
    E.1.1.1Medical condition in easily understood language
    Patients with end stage renal disease receiving hemodialysis.
    Soggetti con malattia renale allo stadio terminale sottoposti a emodialisi
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10053182
    E.1.2Term Arteriovenous graft thrombosis
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 efficacy of MK-2060 compared to placebo in increasing the time to first arteriovenous graft thrombosis event.
    Valutare l'efficacia di MK-2060 rispetto al placebo nell'aumentare il tempo al
    primo evento di trombosi dell'innesto arterovenoso
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of MK-2060 compared to placebo in reducing the number of arteriovenous graft thrombosis events.
    2. To assess the safety and tolerability of MK-2060.
    1. Valutare l'efficacia di MK-2060 rispetto al placebo nella riduzione del
    numero di eventi di trombosi dell'innesto arterovenoso
    2. Valutare la sicurezza e la tollerabilità di MK-2060
    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: There is pharmacokinetics sub study that will take place at selected study sites enrolling approximately 100 participants. Also, there is a Quality of Life measures sub study that will take place at selected sites enrolling approximately 200 participants. No Italian sites will take part in this sub study.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Esiste uno sottostudio di farmacocinetica che si svolgerà in centri clinici selezionati che coinvolgerà circa 100 partecipanti. Inoltre, c'è un sottostudio sulle misure della qualità della vita che si svolgerà in centri clinici selezionati che coinvolgerà circa 200 partecipanti. Nessun centro italiano parteciperà a questo sottostudio.
    E.3Principal inclusion criteria
    1. Has a current diagnosis of ESRD.
    2. Has been receiving hemodialysis (including hemodiafiltration) prescribed >=3 times per week for a minimum of 3 hours per session via mature normally functioning (spKt/V >=1.2), uninfected AVG. Criterion must be met for at least 75% of the sessions over the 4 weeks prior to randomization.
    3. Is male or female, >=18 years of age inclusive, at the time of signing the informed consent.
    4. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

    Is not a WOCBP

    OR

    Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 90 days, corresponding to the time needed to eliminate any study intervention (eg, 5 terminal half-lives) after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.

    A WOCBP must have a negative highly sensitive pregnancy test (serum) within 6 days before the first dose of study intervention.

    The participant must be excluded from participation if the serum pregnancy result is positive.

    The 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 women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    5. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
    1. Presenta una diagnosi attuale di ESRD
    2. Ha ricevuto emodialisi (inclusa emodiafiltrazione) prescritta per >=3 volte a settimanaper un minimo di 3 ore attraverso un innesto arterovenoso normalmente funzionante (spKt/V >=1,2), AVG non infetto. Il criterio deve essere soddisfatto per almeno il 75% delle sessioni nelle 4 settimane precedenti la randomizzazione.
    3. È di sesso maschile o femminile, ha >=18 anni di età compiuti al momento della firma del consenso informato
    4. Una partecipante è ritenuta idonea alla partecipazione se non è in gravidanza o in allattamento e soddisfa almeno una delle seguenti condizioni:

    Non è una donna in età fertile

    OPPURE

    È una donna in età fertile e utilizza un metodo contraccettivo accettabile, oppure si astiene da rapporti eterosessuali come stile di vita preferito e abituale (astinenza a lungo termine e su base persistente), durante il periodo di intervento e per almeno 90 giorni, corrispondenti al tempo necessario per eliminare qualsiasi trattamento dello studio (ad es., 5 emivite terminali) dopo l'ultima dose di trattamento dello studio. Lo sperimentatore deve valutare la possibilità di un insuccesso del metodo contraccettivo (ovvero, mancata compliance, recente avvio) rispetto alla prima dose del trattamento dello studio

    Una donna in età fertile deve presentare un risultato negativo a un test di gravidanza altamente sensibile (sierico) eseguito nei 6 giorni precedenti alla prima dose di trattamento dello studio

    La partecipante deve essere esclusa dallo studio se il risultato del test di gravidanza sul siero è positivo

    Lo sperimentatore ha la responsabilità di prendere in esame l'anamnesi medica, l'anamnesi mestruale e la recente attività sessuale della partecipante per ridurre il rischio di includere nello studio una donna con una gravidanza allo stato iniziale non rilevata

    L'uso del contraccettivo da parte delle donne deve essere coerente con le normative locali relative ai metodi di contraccezione per coloro che partecipano agli studi clinici
    5. Il/La partecipante (o un rappresentante legalmente accettabile) ha fornito il consenso/assenso informato firmato per lo studio. Il/La partecipante può anche fornire il consenso/assenso per future ricerche biomediche. Tuttavia, il/la partecipante può prendere parte allo studio principale senza partecipare alle ricerche biomediche future
    E.4Principal exclusion criteria
    1. Has a recent history of cancer (<1 year). Non-melanoma skin cancers are allowed.
    2. Has a mechanical/prosthetic heart valve.
    3. Had a recent hemorrhagic stroke or lacunar stroke (<1 month).
    4. Had recent evidence of bleeding requiring hospitalization or unplanned medical attention (<1 month), a history (<=2 years) of recurrent bleeding episodes including epistaxis, GI bleeds or GU bleeds requiring medical treatment or events requiring treatment with blood products.
    5. Has a recent history of drug or alcohol abuse or dependence (<1 year).
    6. Life expectancy <12 months.
    7. Is currently receiving or planning to receive anticoagulants or antiplatelet medications (Individuals that plan to be on low dose aspirin (up to 150 mg per day) during the study or require intradialytic heparin, are permitted in the study).
    Prohibited Medications:
    - Oral Anticoagulants: Warfarin, Apixaban, Dabigatran, Rivaroxaban, Edoxaban, Betrixaban.
    - IV/SC Anticoagulants: IV/SC Heparin and LMWH, IV Warfarin, IV Argatroban, IV Bivalirudin, IV Lepirudin, SC fondaparinux, IV antithrombin III.
    - Antiplatelet Medications (P2Y12 inhibitor use is excluded): Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine.
    - NSAIDs (eg, ibuprofen); however, the non-NSAID paracetamol/acetaminophen may be used for minor ailments without prior consultation with the Sponsor.
    8. Has participated in another investigational study within 4 weeks (or 5 half-lives of the investigational drug), whichever is greater, prior to the Screening Visit. The window will be derived from the date of the last use of study treatment in the previous study.
    9. Has abnormal coagulation laboratory results including INR >2.0 and/or PT or aPTT >20% above the normal range.
    10. Has thrombocytopenia (platelet count <50,000/µL).
    11. Has documented severe hypertension (SBP >200 mmHg or DBP >110 mmHg) at screening or randomization.
    12. Is planning on receiving a living donor renal transplant within 12 months (participants are permitted to be candidates for deceased donor renal transplants).
    13. Is planning on receiving an AVF placement within 12 months.
    14. Is planning non-urgent invasive dental surgeries that are liable for significant blood loss within 12 months.
    15. Has had a hypersensitivity reaction to any component of MK-2060 drug product.
    16. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
    1. Presenta un'anamnesi recente di tumore (<1 anno). Sono ammessi tumori cutanei non melanoma.
    2. Presenta una valvola cardiaca meccanica/protesica.
    3. Ha avuto un ictus emorragico recente o un ictus lacunare (<1 mese).
    4. Presentava evidenze recenti di emorragia che richiedeva il ricovero ospedaliero o un'attenzione medica non pianificata (<1 mese), un'anamnesi (<=2 anni) di episodi emorragici ricorrenti, tra cui epistassi, sanguinamenti GI o sanguinamenti UG che richiedevano trattamento medico o eventi che richiedevano il trattamento con prodotti ematici.
    5. Presenta un'anamnesi recente di abuso o dipendenza da droghe o alcol (<1 anno)
    6. Aspettativa di vita <12 mesi
    7. Sta attualmente ricevendo o pianificando di ricevere anticoagulanti o farmaci antiaggreganti (gli individui che prevedono di assumere aspirina a basso dosaggio (fino a 150 mg al giorno) durante lo studio o che richiedono eparina intradialitica sono ammessi nello studio).
    Farmaci vietati:
    - Anticoagulanti orali: warfarin, apixaban, dabigatran, rivaroxaban, edoxaban, betrixaban.
    - Anticoagulanti EV/SC: eparina EV/SC e a basso peso molecolare (LMWH), warfarin EV, argatroban EV, bivalirudina EV, lepirudina EV, fondaparinux SC, antitrombina III EV.
    - Farmaci antiaggreganti (è escluso l'uso di inibitori del P2Y12): clopidogrel, prasugrel, ticagrelor, ticlopidina.
    - FANS (es. ibuprofene); tuttavia, il paracetamolo/l'acetaminofene non FANS può essere utilizzato per disturbi minori senza previa consultazione dello Sponsor.
    8. Ha partecipato a un altro studio sperimentale entro 4 settimane (o 5 emivite del farmaco sperimentale), a seconda di quale sia il periodo più lungo, prima della Visita di screening. La finestra sarà derivata dalla data dell'ultimo utilizzo del trattamento dello studio nello studio precedente.
    9. Presenta anomalie nei risultati di laboratorio della coagulazione, inclusi INR >2,0 e/o PT o aPTT >20% al di sopra del range normale.
    10. Presenta trombocitopenia (conta delle piastrine <50.000/µL).
    11. Presenta ipertensione grave documentata (PAS >200 mmHg o PAD >110 mmHg) allo screening o alla randomizzazione.
    12. Sta programmando di ricevere un trapianto renale da donatore vivente entro 12 mesi (i/le partecipanti possono essere candidati/e a trapianti di donatore deceduto).
    13. Sta pianificando di sottoporsi a posizionamento di FAV entro 12 mesi.
    14. Sta programmando interventi odontoiatrici invasivi non urgenti che possono determinare una significativa perdita di sangue entro 12 mesi.
    15. Ha avuto una reazione di ipersensibilità a qualsiasi componente del prodotto farmaceutico MK-2060.
    16. Fa parte o ha un parente stretto (ad es., coniuge, genitore/tutore legale, fratello/sorella o figlio/a) che fa parte del personale del centro di sperimentazione o dello Sponsor direttamente coinvolto in questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Time to First Arteriovenous Graft (AVG) Thrombosis Event
    Tempo al primo evento di trombosi dell'innesto arterovenoso (AV)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 17 months
    Dalla data della randomizzazione fino alla data del primo evento di trombosi dell'innesto arterovenoso, valutato fino a circa 17 mesi
    E.5.2Secondary end point(s)
    1. Number of Arteriovenous Graft Thrombosis Events
    2. Number of Participants who Experience One or More Adverse Events (AEs)
    3. Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria
    4. Number of Participants Who Discontinue Study Intervention Due to Adverse Event (AE)
    1. Numero di eventi di trombosi dell'innesto arterovenoso
    2. Numero di partecipanti che hanno manifestato uno o più eventi avversi (AE)
    3. Numero di eventi di sanguinamento grave o di eventi di sanguinamento non grave clinicamente rilevanti secondo i criteri della Società internazionale sulla trombosi e l'emostasi (ISTH)
    4. Numero di partecipanti che hanno interrotto il trattamento dello studio a causa di un evento avverso (AE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 17 months
    2. Up to approximately 20 months
    3. Up to approximately 20 months
    4. Up to approximately 17 months
    1. Fino a circa 17 mesi
    2. Fino a circa 20 mesi
    3. Fino a circa 20 mesi
    4. Fino a circa 17 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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
    Studio guidato dagli eventi
    Event driven study
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Argentina
    Australia
    Brazil
    Puerto Rico
    Russian Federation
    United States
    Czechia
    Germany
    Greece
    Italy
    Poland
    Portugal
    Sweden
    Bulgaria
    Romania
    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 years0
    E.8.9.1In the Member State concerned months20
    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 months20
    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: 269
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 121
    F.4.2.2In the whole clinical trial 489
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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