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    Summary
    EudraCT Number:2018-004588-30
    Sponsor's Protocol Code Number:D5180C00011
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-24
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-004588-30
    A.3Full title of the trial
    A Multicenter, Randomized, Open-label, Parallel group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector with Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects with Severe Asthma (PATH-HOME)
    Wieloośrodkowe, randomizowane, otwarte badanie prowadzone w grupach równoległych, oceniające funkcjonalność i sprawność podania podskórnego Tezepelumabu w warunkach domowych za pomocą ampułko-strzykawki z pojedynczą dawką leku i automatycznego wstrzykiwacza u małoletnich oraz dorosłych pacjentów z ciężką postacią astmy (PATH-HOME)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tezepelumab Home Use Study
    Badanie oceniające stosowanie Tezepelumabu w warunkach domowych
    A.3.2Name or abbreviated title of the trial where available
    PATH-HOME
    A.4.1Sponsor's protocol code numberD5180C00011
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03968978
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportAmgen
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.5.6E-mailinformation.center@astrazeneca.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 nameTezepelumab via APFS
    D.3.2Product code MEDI9929 anti-TSLP mAb (AMG157)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTezepelumab
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeMEDI9929
    D.3.9.3Other descriptive nameAMG157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number99 to 121
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTezepelumab via LVAI
    D.3.2Product code MEDI9929 anti-TSLP mAb (AMG157)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTezepelumab
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeMEDI9929
    D.3.9.3Other descriptive nameAMG 157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number99 to 121
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Severe uncontrolled asthma
    Ciężka niekontrolowana astma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Astma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the successful administration of tezepelumab (210 mg, subcutaneous) by injection with an accessorized prefilled syringe (APFS) or autoinjector (AI) in the clinic and at home.
    Ocena skutecznego podskórnego podania tezepelumabu w dawce 210 mg we wstrzyknięciu za pomocą ampułko-strzykawki lub automatycznego wstrzykiwacza w ośrodku i w domu
    E.2.2Secondary objectives of the trial
    To assess the functionality of the APFS or AI devices utilized to administer tezepelumab in clinic and at home.

    To assess the performance of APFS or AI devices used to administer tezepelumab in clinic and at home.

    To monitor the metrics of asthma control in subjects.

    To assess the pharmacokinetics and immunogenicity of tezepelumab administered via APFS or AI in clinic and at home, and to assess the safety and tolerability of tezepelumab.
    Ocena funkcjonalności ampułko-strzykawki lub automatycznego wstrzykiwacza, które są wykorzystywane do podawania tezepelumabu w ośrodku i w domu

    Ocena działania ampułkostrzykawki lub automatycznego wstrzykiwacza, które są wykorzystywane do podawania tezepelumabu w ośrodku i w domu

    Monitorowanie parametrów kontroli astmy

    Ocena farmakokinetyki i immunogenności tezepelumabu podawanego za pomocą ampułkostrzykawki lub automatycznego wstrzykiwacza w ośrodku i w domu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria​

    Male and female subjects aged 12 to 80 years of age at the time of Visit 1​

    Documented physician-diagnosed asthma for at least 12 months prior to Visit 1​

    Evidence of asthma as documented by post BD (albuterol/salbutamol)
    reversibility of FEV1 ≥ 12% AND ≥200 mL (15-60 min after
    administration of 4 puffs of albuterol/salbutamol), documented either:
    in the previous12 months prior to V1, OR demonstrated at V1, V1A, or at V2​.

    Documented history of current treatment with medium- or high-dose ICS for at least 6 months prior to Visit 1 and at least one additional asthma controller medication for at least 3 months prior to Visit 1​.

    Morning pre-bronchodilator (pre-BD) FEV1 of >50% predicted normal at Visit 1, Visit 1A, or Visit 2​.
    Pacjenci płci męskiej i żeńskiej w wieku od 12 do 80 lat podczas wizyty 1

    Udokumentowana astma rozpoznana przez lekarza co najmniej 12 miesięcy przed wizytą 1.

    Objawy astmy udokumentowane na podstawie:
    odwracalności obturacji dróg oddechowych po zastosowaniu wziewnego krótko działającego beta-mimetyku (albuterol/salbutamol) FEV1 ≥12% i 200 ml (15-60 minut po podaniu 4 dawek albuterolu/salbutamolu), wykazanej podczas wizyty 1, wizyty 1A lub wizyty 2 LUB udokumentowanej w okresie ostatnich 12 miesięcy.

    Udokumentowane aktualne leczenie średnią lub wysoką dawką wziewnych glikokortykosterydów przez co najmniej 6 miesięcy poprzedzających wizytę 1 i stosowania co najmniej jednego dodatkowego leku kontrolującego objawy astmy przez co najmniej 3 miesiące przed wizytą 1.

    Poranna wartość FEV1 przed podaniem leku rozszerzającego oskrzela wynosząca >50% wartości należnej podczas wizyty 1, wizyty 1A lub wizyty 2.
    E.4Principal exclusion criteria
    - Any clinically important pulmonary disease other than asthma.
    - History of cancer except basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of the cervix within 12 months prior to Visit 1.
    - A helminth parasitic infection diagnosed within 6 months prior to Visit 1.
    - Current smokers or former smokers with a smoking history of ≥10 pack
    years. Former smokers with a smoking history of <10 pack years, as well
    as users of electronic cigarettes (e.g. vaping) must have stopped for at
    least 6 months prior to Visit 1 to be eligible.
    - History of alcohol or drug abuse within 12 months prior to Visit 1.
    - Tuberculosis requiring treatment within 12 months prior to Visit 1.
    - HIV, Hepatitis B or Hepatitis C.
    - Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.
    - Bronchial thermoplasty in the 24 months prior to Visit 1.
    - Anaphylaxis or documented immune complex disease to any biologic therapy.
    - Evidence of active liver disease, including jaundice or aspartate transaminase, alanine transaminase, or alkaline phosphatase >2 times the upper limit of normal at Visit 1.
    - Non-leukocyte depleted whole blood transfusion in 120 days prior to
    visit 1.
    Jakakolwiek klinicznie istotna choroba płuc inna niż astma.

    Nowotwór złośliwy w wywiadzie, oprócz raka podstawnokomórkowego, ograniczonego raka kolczystokomórkowego skóry lub raka szyjki macicy in situ pod warunkiem, że leczenie z zamiarem wyeliminowania choroby zakończono co najmniej 12 miesięcy przed wizytą 1.

    Rozpoznanie zakażenia pasożytami jelitowymi w okresie 6 miesięcy przed wizytą 1.

    Osoby palące tytoń aktualnie lub w przeszłości w ilości ≥10 paczkolat. Pacjenci, którzy wypalili w przeszłości <10 paczkolat, włączając osoby używające papierosy elektroniczne, także elektroniczne inhalatory nikotyny, mogą być kwalifikowani do badania, jeżeli zaprzestali palenia tytoniu co najmniej 6 miesięcy przed wizytą 1 Długotrwałe nadużywanie alkoholu lub substancji psychoaktywnych w wywiadzie w okresie 12 miesięcy przed wizytą 1.

    Długotrwałe nadużywanie alkoholu lub substancji psychoaktywnych w wywiadzie w okresie 12 miesięcy przed wizytą 1.

    Gruźlica wymagająca leczenia w okresie 12 miesięcy przed wizytą 1.

    Stwierdzone w wywiadzie zaburzenia odporności, w tym dodatni wynik badania w kierunku zakażenia ludzkim wirusem upośledzenia odporności (HIV), zapalenia wątroby typu B lub C.

    Otrzymanie jakiegokolwiek zarejestrowanego lub eksperymentalnego leku biologicznego w okresie 4 miesięcy lub 5 okresów półtrwania (w zależności od tego, który okres jest dłuższy) przed wizytą 1 lub otrzymanie jakiegokolwiek niebiologicznego leku eksperymentalnego w okresie 30 dni lub 5 okresów półtrwania (w zależności od tego, który okres jest dłuższy) przed wizytą 1.

    Pacjenci, którzy otrzymywali leczenie metodą termoplastyki oskrzelowej w okresie 24 miesięcy przed wizytą 1.

    Stwierdzona w wywiadzie anafilaksja lub udokumentowana choroba kompleksów immunologicznych (reakcje nadwrażliwości typu III) po zastosowaniu jakiegokolwiek leczenia biologicznego.

    Objawy aktywnej choroby wątroby, w tym żółtaczka lub aktywność transaminazy asparaginianowej, transaminazy alaninowej lub fosfatazy alkalicznej >2 wyższa od górnej granicy normy podczas wizyty 1.

    Przetoczenie krwi pełnej bez uszczuplenia leukocytów w ciągu 120 dni przed wizytą 1.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of healthcare providers (HCPs) and subjects/caregivers who successfully administered tezepelumab in clinic and at home with APFS.

    Proportion of healthcare providers (HCPs) and subjects/caregivers who successfully administered tezepelumab in clinic and at home with AI.
    Odsetek pracowników służby zdrowia oraz pacjentów/opiekunów, którzy skutecznie podali tezepelumab przy pomocy ampułko-strzykawki w ośrodku i w domu

    Odsetek pracowników służby zdrowia oraz pacjentów/opiekunów, którzy skutecznie podali tezepelumab przy pomocy automatycznego wstrzykiwacza w ośrodku i w domu.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
    tydzień 0. tydzień 4. tydzień 8. tydzień 12. tydzień 16. tydzień 20.
    E.5.2Secondary end point(s)
    Proportion of used/returned APFS devices that passed functional tests and visual inspection and showed no evidence of malfunction.

    Proportion of used/returned AI devices that passed functional tests and visual inspection and showed no evidence of malfunction.

    Proportion of APFS devices that have been reported as malfunctioning (as per the Product Complaints process).

    Proportion of AI devices that have been reported as malfunctioning (as per the Product Complaints process).

    Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) scores.

    Serum trough tezepelumab concentrations and anti-drug antibody (ADA) levels.
    Odsetek zużytych/zwróconych ampułko-strzykawek, które przeszły testy funkcjonalne i kontrolę wzrokową i nie wykazały oznak wadliwego działania
    Odsetek zużytych/zwróconych automatycznych wstrzykiwaczy, które przeszły testy funkcjonalne i kontrolę wzrokową i nie wykazały oznak wadliwego działania.

    Odsetek ampułkostrzykawek, które zgłoszono jako wadliwe (reklamacje produktu).

    Odsetek automatycznych wstrzykiwaczy, które zgłoszono jako wadliwe (reklamacje produktu).

    Zmiana w stosunku do wyjściowego wyniku kwestionariusza kontroli astmy ACQ-6.

    Najniższe stężenie leku w surowicy i przeciwciała przeciwko lekowi (ADA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 0, Week 4, Week 8, Week 12, Week 16, Week 20.

    Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (for ACQ-6 score change from baseline, serum trough concentrations and ADA levels)
    tydzień 0. tydzień 4. tydzień 8. tydzień 12. tydzień 16. tydzień 20.

    tydzień 0. tydzień 4. tydzień 8. tydzień 12. tydzień 16. tydzień 20. tydzień 24. (dla zmiana w stosunku do wyjściowego wyniku kwestionariusza kontroli astmy ACQ-6, najniższego stężenia leku i poziomu przeciwciał ADA)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 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 concerned10
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Japan
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    „LVLS” (Last Visit Last Subject)
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 20
    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: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The ICF allows a legally accepted representative to give consent for subjects where applicable.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 210
    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.
    Nie dotyczy
    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 Decision2019-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-05
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