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    Summary
    EudraCT Number:2019-004219-29
    Sponsor's Protocol Code Number:140041
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Not Authorised
    Date on which this record was first entered in the EudraCT database:2020-02-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-004219-29
    A.3Full title of the trial
    “Personalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn’s Disease (CD): a pilot study”
    "Gepersonaliseerde Azitromycine/metronidAZole in combinatie met standaard inductie therapie, voor het bereiken van een microbioom structuur en metagenoom veranderingen geassocieerd met aanhoudende remissie bij kinderen met ziekte van Crohn: een pilot studie"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Personalized antibiotic therapy in combination with standard therapy to achieve a fecal profile associated with prolonged complaint-free period in pediatric Crohn’s Disease
    Gepersonaliseerde antibiotische therapie in combinatie met standaard therapie voor het bereiken van een ontlasting profiel dat geassocieerd is met langere klachtenvrije periode bij kinderen met de ziekte van Crohn
    A.3.2Name or abbreviated title of the trial where available
    PAZAZ
    A.4.1Sponsor's protocol code number140041
    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 SponsorAmsterdam UMC
    B.1.3.4CountryNetherlands
    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 supportWetenschappelijke Adviesraad Emma Children's Hospital
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportCrohn's and Colitis foundation of America
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC
    B.5.2Functional name of contact pointCharlotte Verburgt
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailc.m.verburgt@amsterdamumc.nl
    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 Yes
    D.2.1.1.1Trade name Azithromycin
    D.2.1.1.2Name of the Marketing Authorisation holderGeneric medication
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAzithromycin
    D.3.4Pharmaceutical form 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 INNAzithromycin
    D.3.9.3Other descriptive nameAZITHROMYCIN
    D.3.9.4EV Substance CodeSUB05660MIG
    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 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 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.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 Yes
    D.2.1.1.1Trade name Metronidazole
    D.2.1.1.2Name of the Marketing Authorisation holderGeneric medication
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMetronidazole
    D.3.4Pharmaceutical form 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 INNMETRONIDAZOLE
    D.3.9.3Other descriptive nameMETRONIDAZOLE
    D.3.9.4EV Substance CodeSUB08922MIG
    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 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 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
    Crohn's Disease
    Ziekte van Crohn
    E.1.1.1Medical condition in easily understood language
    Chronic bowel inflammation
    Chronische darmontsteking
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    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 the potential efficacy of personalized adjunctive antibiotic therapy in maintaining clinical remission in pediatric subjects undergoing SOC induction therapy for mild to moderate Crohn’s disease who have a relapse-associated microbiome profile

    Het primaire doel is het evalueren van de potentiële werkzaamheid van gepersonaliseerde adjunctieve antibiotische therapie voor het handhaven van de klinische remissie bij pediatrische patiënten die CDED-inductietherapie ondergaan voor milde tot matige ziekte van Crohn die een terugval-geassocieerd microbioomprofiel hebben.

    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the potential efficacy of personalized adjunctive antibiotic therapy in improving PRO, components of established disease activity measures in remission, as well as ‘biochemical’ remission in pediatric subjects undergoing SOC induction therapy for mild to moderate Crohn’s disease who have a relapse-associated microbiome profile.

    The exploratory objective is to investigate relationship between changes in subject microbiome composition and changes in disease activity over time.
    De secundaire doelstellingen zijn het evalueren van de potentiële werkzaamheid van gepersonaliseerde adjunctieve antibiotische therapie bij het verbeteren van patiënt-gerapporteerde outcome, componenten van vastgestelde ziekteactiviteit bij remissie, evenals 'biochemische' remissie bij pediatrische patiënten die CDED inductietherapie ondergaan voor milde tot matige ziekte van Crohn met een relaps-geassocieerd microbioomprofiel.

    Het verkennende doel is om de relatie tussen veranderingen in de samenstelling van het microbioom van het onderwerp en veranderingen in ziekteactiviteit in de tijd te onderzoeken.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    microbiome changes associated with maintenance of remission
    Personalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn’s Disease (CD): a pilot study - Protocol v1.5
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent form (and assent form, as applicable)
    2. Stated willingness to comply with all study procedures and availability for the duration of the study
    3. Male or female, aged 3 to 17 years
    4. Diagnosed with CD according to standard clinical and histological criteria, within 36 months of week 0
    5. Exhibiting mild to moderate symptoms of active disease, as determined by a PCDAI score >10 (or >7.5 excluding the height item) and ≤37.5
    6. Evidence of active inflammation based on either: fecal calprotectin level >=250 microgram/g (local laboratory or pre-arranged sponsor testing) within 30 days prior to week 0 visit; or according to accepted endoscopic and histologic evidence obtained during an endoscopy procedure completed within 30 days prior to Week 0 Visit.
    1. Gedateerd en ondertekend informed consent formulier met toestemming voor deelname
    2. Akkoord met deelname onderzoek en bereidheid om deel te nemen aan alle studie procedures gedurende de gehele duur van het onderzoek
    3. Man of vrouw, tussen 3-17 jaar oud
    4. Gediagnostiseerd met ziekte van Crohn volgens de standaard klinische en histologische criteria, met bevestiging van diagnose in uiterlijk 36 maanden voor week 0 van het onderzoek
    5. Symptomen passend bij mild tot matige ziekte van Crohn, gedefinieerd als een PCDAI score >10 (of >7.5 zonder lengte) en ≤ 37.5
    6. Bewijs van inflammatie gebaseerd op een van de volgende: faeces calprotectine >= 250 microgram/g in 30 dagen voor week 0 of volgens endoscopisch en histologisch bewijs verkregen aanwijzingen tijdens een endoscopie binnen 30 dagen voorafgaand aan week 0
    E.4Principal exclusion criteria
    1.Current or previous use of anti-TNF or other biologic therapy
    2.Presence of stricturing, penetrating (intestinal or perianal) and/or fistulizing CD.
    3.Pregnancy or lactation
    4.Have undergone intestinal resection
    5.Laboratory diagnosis of Clostridium Difficile Infection (CDI), if performed for clinical indication
    6.Treatment with another investigational drug or other intervention within 30 days before week 0
    7.Risk factors for arrhythmia including history of prolonged QTc, hypokalemia or hypomagnesemia, resting bradycardia, or concurrent treatment with other drugs with potential for QT prolongation.
    8.History of Cockayne syndrome
    9.Prior diagnosis of any hematologic condition/blood dyscrasia which may result in leukopenia (even if leukocyte count is normal at screening)
    10.Known allergy or intolerance to azithromycin or metronidazole
    11.Subjects who received IV anti-infective within 35 days prior to week 0 visit or oral anti-infectives within 14 days prior to the week 0 visit.
    12.Subject on oral aminosalicylates who has not been on stable doses for greater than, or discontinued within, at least 14 days prior to week 0.
    13.Subject on cyclosporine, tacrolimus or mycophenolate mofetil. Stable doses (no change within 14 days prior to week 0) of Azathioprine, 6-mercaptopurine or MTX are not a reason for exclusion.
    14.Subject who received fecal microbial transplantation within 35 days prior to week 0 visit.
    15.Screening laboratory and other analyses show any of the following abnormal results:
    o AST, ALT > 2 X upper limit of the reference range (as determined locally at each site)
    o Urea, Creatinine > 1.5X upper limit of the reference range (as determined locally at each site)
    o White blood cell (WBC) count < 3.0 X 109/L
    o Total bilirubin >= 20 micromol/liter (1.17mg/dl); except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome
    o Hemoglobin < 80 gram/liter
    o Platelets < 100,000/μL
    1. Actueel of voormalig gebruik van TNF-alfa remmers of andere biologicals
    2. Aanwezigheid van stricturen, penetrerende (intestinale of perianale) en/of fistulerende ziekte van Crohn
    3. Zwangerschap of lactatie
    4. Het hebben ondergaan van intestinale resectie
    5. Diagnose met Clostridium Difficile infectie (indien uitgevoerd voor klinische indicatie)
    6. Behandeling met een andere geneesmiddel of interventie voor onderzoeksdoeleinden in de 30 dagen voorafgaand aan week 0 bezoek
    7. Risicofactoren voor arytmie, lang QTc in voorgeschiedenis, hypokaliemie, hypomagnesiemie, bradycardie (in rust), inname van medicatie geassocieerd met QT verlenging
    8. Voorgeschiedenis met Cockayne syndroom
    9. Hematologische aandoening in de voorgeschiedenis die kan resulteren in leukopenie (zelfs indien leukocyten bij screening normaal zijn)
    10. Bestaande allergie of intolerantie voor azytromycine of metronidazol
    11. Gebruik van intraveneuze anti-infectieuze middelen in de 35 dagen voorgaand week 0 bezoek of orale anti-infectieuze middelen 14 dagen voor week 0 bezoek
    12. Gebruik van orale aminosalicylaten die geen stabiele dosis voor langer dan, of gestopt in, de 14 dagen voorafgaand aan week 0 bezoek
    13. Gebruik van cyclosporine, tacrolimus of mycofenolaat mofetil. Stabiele doses (geen verandering in 14 dagen voorafgaand aan week 0) van azathioprine, 6-mercaptoourine of MTX zijn geen reden voor exclusie
    14. Feacestransplantatie in 35 dagen voor week 0 bezoel
    15. Screenende labwaarden of andere analyses die een van de volgende resultaten laat zien:
    - ASAT, ALAT >2x bovenste grenswaarde (lokale grenswaarden)
    - Ureum, creatinine> 1.5 keer bovenste grenswaarde (lokale grenswaarden)
    - White blood cell (WBC) count < 3.0 x 109 /L
    - Totale bilirubine >=20 micromol/liter (1.17 mg/dl); behalve voor deelnemers met geïsoleerde elevatie van indirect bilirubine gerelateerd aan syndroom van Gilbert
    - Hemoglobine <80g/L
    - Trombocyten <100.000/μL
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome variable: Sustained remission defined as no need of re-induction for clinical flare (new course of nutritional therapy, need to start steroids), steroid dependence, biologic (anti-TNF) use, and/or intestinal surgery by 12 months.
    Primaire uitkomstvariabele: aanhoudende remissie gedefinieerd als geen behoefte aan re-inductie voor klinische opvlamming (zoals nieuw verloop van voedingstherapie, noodzaak om steroïden te starten), steroïde afhankelijkheid, biologisch (anti-TNF) gebruik en / of darmchirurgie in periode van 12 maanden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 weken
    E.5.2Secondary end point(s)
    Secondary Outcome variables: Longitudinal (clustered and with respect to baseline) changes in disease activity indices (PCDAI: 0-100) components and inflammatory markers in stool and blood at each study visit up to 12 months. Longitudinal (clustered and with respect to baseline) changes in patient-reported outcomes (PRO) by 12 months.
    Exploratory Outcome variable: Longitudinal (clustered and with respect to baseline) changes in fecal microbiome taxonomic composition or in total gene (metagenome) content. The changes will be analyzed for association with changes in disease activity (e.g. relapse or sustained remission) over time up to 12 months.
    Secundaire uitkomstvariabelen: Longitudinale (geclusterd en ten opzichte van baseline) veranderingen in ziekteactiviteitindices (PCDAI: 0-100), componenten en ontstekingsmarkers in ontlasting, en bloed bij elk studiebezoek tot 12 maanden. Daarnaast ook nog longitudinale (geclusterde en ten opzichte van baseline) veranderingen in door de patiënt gerapporteerde uitkomsten (PRO) gedurende 12 maanden.

    Verkennende uitkomstvariabele: longitudinale (geclusterde en ten opzichte van baseline) veranderingen in de fecale microbioom samenstelling of in het totale metagenoom. De veranderingen zullen worden geanalyseerd op verband met veranderingen in ziekteactiviteit (bijv. terugval of aanhoudende remissie) in de periode tot 12 maanden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 weken
    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 No
    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) 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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    baseline gut microbiome-based randomization
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Crohn's Disease Exclusion Diet (CDED)
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    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
    Israel
    United States
    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
    The end of the study is defined as completion of the last visit or procedure shown in the SoA in the trial globally.
    Eind van de studie wordt gedefinieerd als het afronden van het laatste bezoek of procedure van de laatst geincludeerde zoals beschreven in het protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 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) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-02-04. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 20
    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)
    Treatment or care after the trial is conform standard of care.
    Behandeling en/of zorg na de trial is gelijk aan de reguliere zorg.
    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 Decision2020-02-04
    N.Ethics Committee Opinion of the trial applicationNot-Favourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    P. End of Trial
    P.End of Trial StatusNot Authorised
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