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    Summary
    EudraCT Number:2022-000297-26
    Sponsor's Protocol Code Number:APHP210081
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-01
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-000297-26
    A.3Full title of the trial
    lNA
    Comparaison d’une faible dose à une dose standard d’insulinothérapie dans l’acidocétose diabétique de l’adulte en réanimation et unité de surveillance continue pour diminuer les complications métaboliques : un essai contrôlé randomisé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    LOSTINDIAB
    LOSTINDIAB
    A.4.1Sponsor's protocol code numberAPHP210081
    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 SponsorAssistance Publique – Hôpitaux de Paris (AP-HP)
    B.1.3.4CountryFrance
    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 supportMinistère de la Santé, PHRC Interrégional, 2020
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP
    B.5.2Functional name of contact pointSEYMOUR-INAMO
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue Claude VELLEFAUX
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+3301 44 84 17 42
    B.5.5Fax number+3301 44 84 17 01
    B.5.6E-mailkarine.seymour@aphp.fr
    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 ACTRAPID 100 UI/ml solution injectable en flacon
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.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 UMULINE RAPIDE 100 UI/1 mL solution injectable en flacon
    D.2.1.1.2Name of the Marketing Authorisation holderLILLY FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.IMP: 3
    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 HUMALOG 100 unités/mL solution injectable en flacon
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN LISPRO
    D.3.9.1CAS number 133107-64-9
    D.3.9.4EV Substance CodeSUB08198MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.IMP: 4
    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 NovoRapid 100 unités/ml, solution injectable en flacon
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN ASPART
    D.3.9.1CAS number 116094-23-6
    D.3.9.4EV Substance CodeSUB08195MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    NA
    l’acidocétose diabétique de l’adulte en réanimation et unité de surveillance continue
    E.1.1.1Medical condition in easily understood language
    NA
    Acidocétose diabétique de l’adulte
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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
    NA
    Evaluer si une posologie réduite d’insuline (0,05 UI/kg/h contre 0,10 UI/kg/h) pour la prise en charge de l’ACD chez les patients adultes admis en unité de surveillance continue (USC) ou en réanimation diminue l’incidence de complications métaboliques (hypokaliémie < 3,5 mmol/L et/ou hypoglycémie < 3,9 mmol/L)
    E.2.2Secondary objectives of the trial
    NA
    Les objectifs secondaires sont:
    1. Comparer le temps de résolution de l’ACD en non-infériorité
    2. Comparer le taux d'hypokaliémie < 3,5 mmol/L
    3. Comparer le taux d'hypoglycémie < 3,9 mmol/L
    4. Comparer le taux d'hypoglycémie sévère < 2,9 mmol/L
    5. Comparer le taux d'arythmie cardiaque aiguë
    6. Évaluer l’impact de la dose d’insuline sur les besoins métaboliques :
    Comparer le recours aux solutés glucosés hypertoniques
    Comparer la quantité totale de glucose perfusé
    Comparer la quantité totale de la suppléance en potassium (orale et intraveineuse)
    7. Comparer la durée du séjour en unité de surveillance continue ou en réanimation en non-infériorité
    8. Evaluer l'impact de la dose réduite d'insuline au sein des différentes populations : DT1, DT2 et diabète secondaire, et acidocétose inaugurale, sur :
    Le temps de résolution de l’ACD
    Le taux d'hypokaliémie (potassium < 3,5 mmol/L)
    Le taux d'hypoglycémie (glucose < 3,9 mmol/L)
    Le taux d'hypoglycémie sévère (glucose < 2,9 mmol/L)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    NA
    - Adulte âgé de 18 ans ou plus
    - Admis en unité de surveillance continue ou en réanimation
    - ACD sévère avec tout type de diabète (type 1, diabètes de type 2 et secondaires, et ACD inaugurale) définie comme l'association des trois paramètres suivants :
    - glucose > 11 mmol / L ou diabète connu
    - cétonémie > 3 mmol / L ou cétonurie ≥ 2+
    - bicarbonate <15 mmol / L et/ou pH veineux < 7,3
    - Randomisation possible dans les 2 heures suivant l'initiation de l'insuline
    - Consentement éclairé écrit du patient ou d'un parent/proche/personne de confiance le cas échéant. En cas d'absence d'un ou d'un parent/proche/personne de confiance, le patient peut être inclus en procédure d'urgence et le consentement sera recueilli dès que possible.
    E.4Principal exclusion criteria
    NA
    - ACD non diabétique (de jeûne ou alcoolique)
    Patient pesant moins de 30 Kg
    - Hypokaliémie <3,5 mmol/L au moment de l'inclusion
    - Etat hyperglycémique hyperosmolaire (défini comme une osmolarité plasmatique efficace supérieure à 320 mosmol/L)
    - Patient non couvert par la sécurité sociale
    - Patientes enceintes ou allaitantes
    - Patient sous tutelle ou curatelle
    - Patient privé de liberté par une décision judiciaire ou administrative
    - Patient avec une maladie rénale sous dialyse
    - Insuffisance hépatique aiguë ou chronique avec un facteur V < 50%
    - Patients recevant une dose quotidienne de corticoïdes élevée (≥ 0,5 mg/kg)
    - Patient inclus dans un protocole de recherche RIPH1

    Il est à noter que les patients diagnostiqués COVID + pourront être inclus dans cette étude. En effet, il n’y a pas d’argument que les patients diagnostiqués COVID + réagissent différemment que les patients non COVID à la prise en charge de l’ACD.

    E.5 End points
    E.5.1Primary end point(s)
    NA
    Critère principal composite : hypokaliémie < 3,5 mmol/L et/ou hypoglycémie < 3,9 mmol/L jusqu’à la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    A la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    E.5.2Secondary end point(s)
    NA
    Critères d’évaluation secondaires
    1. Temps en heures entre la randomisation et la résolution de l'ACD (définie par pH>7,30 et cétonémie < 0,3 mmol/L) ou 48h après l’inclusion si l’ACD n’est pas résolue
    2. Proportion de patients avec au moins un épisode d’hypokaliémie < 3,5 mmol/L entre la randomisation et la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    3. Proportion de patients avec au moins un épisode d’hypoglycémie < 3,9 mmol/L entre la randomisation et la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    4. Proportion de patients avec au moins un épisode d’hypoglycémie sévère < 2,9 mmol/L entre la randomisation et la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    5. Proportion de patients avec apparition d’une nouvelle arythmie cardiaque diagnostiquée par l'analyse ECG (fibrillation atriale et troubles du rythme ventriculaire) et la surveillance scopique entre la randomisation et la résolution de l'ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    6. 6.a. Proportion de patients ayant reçu au moins une perfusion de soluté glucosé à 30% ou plus de 1000 mL de soluté glucosé à 10% (ce qui témoigne de la tendance à l’hypoglycémie) entre la randomisation et la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    6.b. Quantité de glucose perfusée (en grammes) (glucose 5%, 10% et 30%) entre la randomisation et la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    6.c Apports de potassium (en grammes) par voie orale et intraveineuse entre la randomisation et la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    7. Durée du séjour en unité de surveillance continue et/ou réanimation (heures)
    8. Au sein des différentes populations (DT1, DT2 et diabète secondaire, et acidocétose inaugurale) :
    8.a. Temps en heures entre la randomisation et la résolution de l'ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    8.b. Proportion de patients avec au moins un épisode d’hypokaliémie < 3,5 mmol/L entre la randomisation et la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    8.c. Proportion de patients avec au moins un épisode d’hypoglycémie < 3,9 mmol/L entre la randomisation et la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    8.d. Proportion de patients avec au moins un épisode d’hypoglycémie sévère < 2,9 mmol/L entre la randomisation et la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    A la résolution de l’ACD ou 48h après l’inclusion si l’ACD n’est pas résolue
    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 No
    E.6.4Safety No
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    L’insuline sera diluée à 1 UI/ml dans du NaCl 0,9% pour le bras de randomisation contrôle et à 0,5 U
    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 concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days2
    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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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
    Non
    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 Decision2022-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
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