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    Summary
    EudraCT Number:2017-002156-84
    Sponsor's Protocol Code Number:63623872FLZ3001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-04-10
    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 number2017-002156-84
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection
    Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato con placebo, per valutare l’efficacia e la sicurezza di pimodivir in combinazione con il trattamento standard di cura in pazienti adolescenti, adulti e anziani ricoverati per infezione da influenza A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SAPPHIRE - A study to see if pimodivir in combination with standard of care treatment is useful and safe in the treatment of adolescent, adult and elderly hospitalized patients with influenza A infection.
    SAPPHIRE - Studio per valutare se pimodivir in combinazione con il trattamento standard di cura sia utile e sicuro nel trattamento di pazienti adolescenti, adulti e anziani ricoverati per infezione da influenza A.
    A.3.2Name or abbreviated title of the trial where available
    SAPPHIRE - A study to see if pimodivir in combination with standard of care treatment is useful and
    SAPPHIRE - Studio per valutare se pimodivir in combinazione con il trattamento standard di cura sia
    A.4.1Sponsor's protocol code number63623872FLZ3001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/135/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715242166
    B.5.5Fax number0031715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 namePimodivir
    D.3.2Product code JNJ-63623872-ZCD
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPimodivir
    D.3.9.1CAS number 1777721-70-6
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameJNJ-63623872-ZCD
    D.3.9.4EV Substance CodeSUB174944
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Influenza A Infection
    Infezione da influenza A
    E.1.1.1Medical condition in easily understood language
    Seasonal flu
    Influenza stagionale
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate superiority of pimodivir in combination with standard-of-care (SOC) treatment compared to placebo in combination with SOC treatment on Day 6, with respect to the clinical outcome on the hospital recovery scale.
    L’obiettivo primario è valutare la superiorità di pimodivir in combinazione con il trattamento standard di cura (SOC) rispetto al placebo in combinazione con il trattamento SOC il Giorno 6, in riferimento all’esito clinico sulla scala di recupero ospedaliero.
    E.2.2Secondary objectives of the trial
    Compare pimodivir (Pi) in combination with SOC treatment (tmt) to placebo in combination with SOC tmt (Pi+SOC_Pl+SOC) re.:
    * Safety, tolerability
    * All-cause mortality
    * Incidence, duration of antibiotic tmt
    * No. of subjects needing extended tmt, requiring re-hospitalization, not hospitalized at Day 6
    * Time to clin response
    * Time to improvement of respiratory status
    Evaluate superiority of Pi+SOC vs.Pl+SOC with respect to:
    * Length of hospital stay, time in ICU, time on mechanical ventilation, time to return to daily activities
    * Clinical outcome on hospital recovery scale
    * Incidence of complications associated with influenza after start of study tmt
    * Time to viral negativity a. viral load over time by qRT-PCR and viral culture
    * PK of Pi; PK/PD relationships of Pi
    Investigate:
    * Acceptability (taste, swallowability) of Pi formulation in adolescents
    * Emergence of viral resistance against Pi
    * Virologic response by baseline resistance to Pi/other antivirals in SOC
    Valutare pimodivir (Pi) in combinazione con il trattamento SOC (tmt) rispetto al placebo in combinazione con il trattamento SOC (Pi+SOC_Pi+SOC):
    *sicurezza, tollerabilità
    *mortalità per qualsiasi causa
    *incidenza e la durata del trattamento antibiotico
    *numero di soggetti che necessitano di un trattamento esteso tmt, di un nuovo ricovero, non ricoverati il Giorno 6
    *tempo alla risposta clinica
    *tempo al miglioramento dello stato respiratorio
    Valutare la superiorità di Pi+SOC vs PI+SOC in riferimento ai seguenti parametri:
    *durata della degenza ospedaliera, intervallo di tempo trascorso in una unità di terapia intensiva (UTI), durata della terapia con ventilazione meccanica, tempo necessario per il ritorno alle attività quotidiane
    *esito clinico sulla scala di ricovero ospedaliero
    *all’incidenza di complicazioni associate all’influenza dopo l’inizio del trattamento dello studio
    *tempo alla negatività virale;carica virale nel tempo mediante qRT-PCR e coltura virale
    * PK di Pi; relazionPK
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Taste and Swallowability in adolescents (integrated part of the protocol)
    Gusto e deglutibilità negli adolescenti (parte integrata del protocollo)
    E.3Principal inclusion criteria
    • Male or female, 13 to 85 years of age, inclusive. Note: Adolescent subjects (13-17 years) will be enrolled in selected countries and study sites consistent with local regulations.
    • Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based molecular diagnostic assay.
    • Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (eg, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including subjects admitted to the intensive care unit (ICU). Note: For the purpose of the protocol, subjects admitted under “observation” status with an anticipated length of stay beyond 24 hours are eligible for enrollment.
    • Enrollment and initiation of study drug treatment ≤96 hours after onset of influenza symptoms.
    • Having an SpO2 <94% on room air. Subjects with known pre influenza SpO2 <94% must have an SpO2 decline ≥3% from pre-influenza SpO2.
    • Having a screening/baseline NEWS of ≥4.

    Treatment Extension Criteria - Subjects will be given the option for treatment extension in case all of the following conditions are met:
    • The subject completed the 5-day treatment period.
    • The subject is still hospitalized.
    • Subject has an ongoing respiratory deficiency as evidenced by having an SpO2 <94% on room air, or in case of pre-existing chronic hypoxia (eg, due to COPD), the current blood oxygen saturation on room air is lower than pre-influenza infection levels by at least 2%.
    • The subject is expected to derive clinical benefit from extending the treatment period, in the opinion of the investigator.
    • The investigator agrees to extend treatment with the same SOC. If the SOC contained no influenza antiviral during the first treatment period, no new influenza antiviral can be started in the treatment extension as part of the SOC.
    -Soggetti ambosessi, 13 e 85 anni compresi. Nota: i soggetti adolescenti (13-17 anni) saranno arruolati in Paesi e centri di studio selezionati conformemente alle normative locali.
    -Positività all’infezione da influenza A dopo la comparsa dei sintomi determinata mediante un saggio diagnostico molecolare basato sulla reazione a catena della polimerasi (PCR).
    -Necessità di ricovero per il trattamento dell’infezione da influenza e/o di complicazioni della stessa (ad es. segni radiologici di malattia delle vie respiratorie inferiori, shock settico, coinvolgimento del sistema nervoso centrale [SNC], miosite, rabdomiolisi, esacerbazione acuta della nefropatia cronica, grave disidratazione, miocardite, pericardite, cardiopatia ischemica, esacerbazione di una pneumopatia cronica sottostante, compresi asma, broncopneumopatia cronica ostruttiva [BPCO], scompenso di diabete mellito precedentemente controllato), che comprende i soggetti ricoverati nell’unità di terapia intensiva (UTI). Nota: ai fini del protocollo, i soggetti ricoverati in stato di “osservazione” con una durata prevista della degenza oltre 24 ore sono idonei all’arruolamento.
    -Arruolamento e inizio del trattamento con il farmaco dello studio ≤96 ore dopo la comparsa dei sintomi influenzali.
    -SpO2 <94% in aria ambiente. I soggetti con SpO2 pre-influenza <94% nota devono mostrare una riduzione nella SpO2 ≥3% rispetto alla SpO2 pre-influenza.
    -Punteggio NEWS allo screening/al basale ≥4.
    E.4Principal exclusion criteria
    • Received more than 3 doses of influenza antiviral medication (eg, oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one day prior to screening.
    • Unwilling to undergo regular nasal mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal MT specimens.
    • Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive).
    • Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome.
    • Chronic hepatitis C infection undergoing antiviral therapy.
    • Severely immunocompromised in the opinion of the investigator (eg, cluster of differentiation 4+ [CD4+] count <200 cells/mm3, absolute neutrophil count <750/mm3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, any history of a lung transplant).
    -Precedente trattamento con più di 3 dosi di farmaco antivirale antinfluenzale (ad es. oseltamivir [OST] o zanamivir) o qualsiasi dose di ribavirina nelle 2 settimane precedenti la prima assunzione del farmaco dello studio. Trattamento endovenoso (EV) con peramivir risalente a oltre un giorno prima dello screening.
    -Riluttanza a sottoporsi al regolare prelievo di tamponi nasali del turbinato medio (TM) o presenza di una qualsiasi anomalia fisica che limiti la possibilità di raccogliere regolarmente campioni nasali di TM.
    -Angina pectoris instabile o infarto miocardico nei 30 giorni precedenti lo screening (compreso).
    -Presenza di aritmie cardiache clinicamente significative, aritmia atriale instabile non controllata o aritmia ventricolare sostenuta o fattori di rischio per la sindrome da torsione di punta.
    -Infezione cronica da epatite C sottoposta a terapia antivirale.
    -Immunocompromissione grave secondo il parere dello sperimentatore (ad es. conta di cellule positive per il cluster di differenziazione 4+ [CD4+] <200 cellule/mm3, conta neutrofilica assoluta <750/mm3, primo ciclo di chemioterapia completato nelle 2 settimane precedenti lo screening, anamnesi di trapianto di cellule staminali entro 1 anno prima dello screening, qualsiasi anamnesi di trapianto di polmone).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the hospital recovery scale as assessed on Day 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The hospital recovery scale assesses a subject’s clinical status and will be assessed as the subject’s condition on Day 6 as the primary endpoint.
    E.5.2Secondary end point(s)
    1. Safety and tolerability based on assessment of AEs, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), vital signs, and peripheral capillary oxygen saturation.
    2. Length of hospital stay.
    3. Length of time in the ICU.
    4. Length of time on mechanical ventilation.
    5. The hospital recovery scale as assessed each separate day from Days 4 to 14 (excluding the primary time point).
    6. Time to return to daily activities.
    7. Incidence of complications associated with influenza after the start of study treatment.
    8. All-cause mortality.
    9. Incidence and duration of antibiotic treatment.
    10. The number (proportion) of subjects needing extended treatment.
    11. The number (proportion) of subjects requiring re-hospitalization.
    12. The number (proportion) of subjects not hospitalized at Day 6.
    13. Time to clinical response.
    14. Time to respiratory response.
    15. PK parameters of pimodivir (ie, plasma concentration just prior to the beginning or at the end of a dosing interval [Ctrough], Cmax, tmax, and AUC12h), as determined by population PK analysis.
    16. PK/pharmacodynamic (PD) analyses.
    17. The acceptability of the pimodivir formulation in adolescents, as measured by a taste and swallowability questionnaire.
    18. Time to viral negativity by qRT-PCR and viral culture.
    19. Viral load over time by qRT-PCR and viral culture.
    20. The emergence of viral resistance against pimodivir detected by genotyping and/or phenotyping.
    21. Virologic response by baseline viral resistance to pimodivir/other antivirals in the SOC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-4., 6.-9. Day 33
    5. Day 14
    10.-16. Final analysis
    17. Day 5
    18.-20 Day19
    21. Day 0/1
    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 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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    - Acceptability of pimodivir formulation in adolescents
    - Emergence of viral resistance against pimodivir
    - Virologic response to pimodivir/other antivirals in the SOC
    - Accettabilità della formulazione di pimodivir negli adolescenti
    - Emergenza della resistenza virale contro pimodivir
    - Risposta virologica a pimodivir / altri antivirali nella SOC
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Progetto aggiuntivo al SoC (scelta dello sperimentatore: terapia antivirale e / o terapia di support
    Add-on design to SoC (investigator's choice: antiviral therapy and/or
    supportive care)
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Belgium
    Brazil
    Bulgaria
    Chile
    Czech Republic
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Peru
    Poland
    Romania
    Russian Federation
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Vietnam
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescents 13 to 17 years old
    Adolescenti tra i 13 e i 17 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 600
    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 Decision2018-06-13
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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