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    Summary
    EudraCT Number:2015-005541-30
    Sponsor's Protocol Code Number:APD003
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-13
    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 number2015-005541-30
    A.3Full title of the trial
    AN OPEN-LABEL, EXPLORATORY, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF UCB5857 IN SUBJECTS WITH ACTIVATED PHOSPHOINOSITIDE 3 KINASE (PI3K) DELTA SYNDROME (APDS)
    ÉTUDE D’EXTENSION MULTICENTRIQUE, EXPLORATOIRE, OUVERTE, ÉVALUANT LA TOLÉRANCE À LONG TERME, LA SÉCURITÉ D’EMPLOI, LA PHARMACOCINÉTIQUE ET L’EFFICACITÉ DE L’UCB5857 CHEZ DES PATIENTS PRÉSENTANT UN SYNDROME DE PHOSPHO-INOSITIDE-3-KINASE (PI3K) DELTA ACTIVÉE (SYNDROME APDS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of UCB5857 in subjects with APDS
    Etude de l'UCB5857 chez des patients présentant un syndrôme APDS
    A.4.1Sponsor's protocol code numberAPD003
    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 SponsorUCB BioPharma SPRL
    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 supportUCB BioPharma SPRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+4921734815 15
    B.5.5Fax number+4921734815 73
    B.5.6E-mailclinicaltrials@ucb.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 nameUCB5857
    D.3.2Product code UCB5857
    D.3.4Pharmaceutical form Capsule, hard
    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 INNUCB5857
    D.3.9.1CAS number 1362850-20-1
    D.3.9.2Current sponsor codeUCB5857
    D.3.9.4EV Substance CodeSUB122669
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 nameUCB5857
    D.3.2Product code UCB5857
    D.3.4Pharmaceutical form Capsule, hard
    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 INNUCB5857
    D.3.9.1CAS number 1362850-20-1
    D.3.9.2Current sponsor codeUCB5857
    D.3.9.4EV Substance CodeSUB122669
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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: 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 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 nameUCB5857
    D.3.2Product code UCB5857
    D.3.4Pharmaceutical form Capsule, hard
    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 INNUCB5857
    D.3.9.1CAS number 1362850-20-1
    D.3.9.2Current sponsor codeUCB5857
    D.3.9.4EV Substance CodeSUB122669
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Activated PI3K delta Syndrome (APDS)
    Syndrôme de la PI3K (phospo-inositide-3-kinase) delta activée
    E.1.1.1Medical condition in easily understood language
    Activated PI3K delta Syndrome (APDS)
    Syndrôme de la PI3K (phospo-inositide-3-kinase) delta activée
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the long-term safety and tolerability of UCB5857 in subjects with APDS.
    L'objectif principal est d'évaluer la tolérance et la sécurité d'emploi à long terme de l'UCB5857 chez des patients présentant un syndrome APDS.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the long-term PK profile of UCB5857 in subjects with APDS through sparse sampling.
    L’objectif secondaire est d’évaluer le profil PK à long terme de l’UCB5857 chez des patients présentant un syndrome APDS, par échantillonnage épars.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator; and be able to give written informed consent to participate in the study.
    5. Subject must complete the full Treatment Period of APD001 and must be expected to have a reasonable benefit from the long-term administration of UCB5857 in the medical judgment of the SMC following review of the subject’s overall response in APD001. The SMC from APD001 will confirm each subject’s eligibility based on an evaluation of individual benefit-risk balance.
    8. Contraception methods for male subjects and their female partners:
    - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the last administration of study drug (anticipated 5 half lives).
    - In addition, the female partner of childbearing potential of a male subject must be willing to use a highly effective method of contraception (as above) during the study period and for 3 months after the last administration of study drug.

    Additional inclusion criteria are outlined in section 6.1 of the clinical trial protocol.
    2. L'investigateur doit considérer que le patient/son représentant légal est fiable et capable de respecter le protocole (par exemple, il doit pouvoir comprendre et remplir les carnets journaliers), le calendrier des visites et la prise de médicaments, et qu'il a la capacité de fournir son consentement éclairé écrit de participation à l'étude.
    5. Le patient doit terminer la totalité de la période de traitement de l'étude APD001 et doit pouvoir attendre un effet bénéfique raisonnable de l'administration à long terme de l'UCB5857 d'après le jugement médical du CSS, après l'examen de la réponse globale du patient dans l'étude APD001. Le CSS de l'étude APD001 confirmera l'éligibilité de chaque patient sur la base d'une évaluation de l'équilibre individuel du rapport bénéfices risques.
    8. Moyens de contraception pour les patients et leurs partenaires féminines :
    - Les patients ayant une partenaire en âge de procréer doivent accepter d'utiliser un préservatif lors des rapports sexuels pendant l'étude et les 3 mois suivant l'administration finale du médicament à l'étude (ce qui correspond, selon les prévisions, à 5 demi-vies).
    - En outre, la partenaire en âge de procréer d'un patient participant à l’étude doit accepter d'utiliser un moyen de contraception hautement efficace (comme décrit ci-dessus) pendant l'étude et les 3 mois suivant l'administration finale du médicament à l'étude.

    Les autres critères d'inclusion se trouvent en section 6.1 du protocole de l'étude.
    E.4Principal exclusion criteria
    1. Subject has participated in a clinical study with an investigational medicinal product (IMP) within 3 months of enrollment into the current study (excluding participation in APD001) or subject is currently participating in another study of an IMP (or a medical device).
    2. Subject has a history of alcohol or substance drug abuse/dependence.
    3. Subject has a history of allogenic bone marrow transplant.
    4. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study.
    5. Subject has any new significant uncontrolled condition or an ongoing SAE from the previous study (APD001) that was assessed as related to UCB5857.
    6. Subject has a known hypersensitivity to any components of UCB5857 or comparative drugs as stated in this protocol.
    7. Subject is female and is breast feeding, pregnant, or plans to become pregnant, or to start breast feeding during the study, or within 3 months following last dose of UCB5857.
    11. Subject has >2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin (≥1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%).
    For enrolled subjects with an APD003 screening result >ULN for ALT, AST, ALP, or total bilirubin, a diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the eCRF.
    If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at Screening, repeat the tests prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor.
    12. Subject has a history of or known risk factors for liver disease (other than the disease under study), for example (but not limited to): bile duct disorders, hereditary condition with hepatic involvement, exposure to toxins, and hepatotropic infectious agents.

    Additional exclusion criteria are outlined in section 6.2 of the clinical trial protocol.
    1. Participation à une étude clinique évaluant un autre médicament à l'étude (ME) dans les 3 mois précédant le recrutement dans la présente étude (en dehors de la participation à l'étude APD001) ou participation en cours à une autre étude évaluant un médicament à l'étude (ou un dispositif médical).
    2. Antécédents de consommation chronique d’alcool ou de toxicomanie.
    3. Antécédents de greffe allogénique de moelle osseuse.
    4. Pathologie médicale ou psychiatrique significative, susceptible, d'après l'investigateur, de mettre en péril le patient ou de compromettre sa capacité à participer à cette étude.
    5. Présence d'une nouvelle pathologie non contrôlée significative ou d'un EIG en cours depuis l'étude précédente (APD001), évalué(e) comme lié(e) à l'UCB5857.
    6. Hypersensibilité connue à l’un des composants de l'UCB5857 ou aux médicaments comparatifs indiqués dans ce protocole.
    7. Allaitement ou grossesse en cours ou prévu(e) pendant l’étude ou dans les 3 mois suivant la dernière administration de l'UCB5857.
    11. Taux > 2 x limite supérieure de la normale (LSN) pour n'importe lequel des paramètres suivants : alanine aminotransférase (ALAT), aspartate aminotransférase (ASAT), phosphatases alcalines (PAL) ou bilirubine totale (≥ 1,5 x LSN si syndrome de Gilbert connu). Si le patient présente des élévations uniquement de la bilirubine totale > LSN et < 1,5 x LSN, il convient de fractionner la bilirubine pour identifier un syndrome de Gilbert possible non diagnostiqué (c'est-à-dire, bilirubine directe < 35 %).
    Pour les patients recrutés avec un résultat de sélection dans l'étude APD003 > LSN en ce qui concerne les taux d'ALAT, ASAT, PAL ou bilirubine totale, un diagnostic et/ou la cause d'une élévation cliniquement significative doivent être compris et enregistrés dans le cahier d'observation électronique.
    Si le patient présente à la sélection un taux d'ALAT, ASAT ou PAL >LSN ne répondant pas à la limite de non inclusion, il convient de répéter le dosage avant l'administration du traitement, pour s'assurer qu'il n'y a plus d'augmentation cliniquement significative en cours. En cas d'augmentation cliniquement significative, l'inclusion du patient doit être discutée avec le moniteur médical.
    12. Antécédents ou facteurs de risque connus d'hépatopathie (autre que la maladie en cours d'étude), par exemple (notamment) : affection des voies biliaires, pathologie héréditaire avec atteinte hépatique, exposition à des toxines, et agents infectieux hépatotropes.

    Les autres critères d'inclusion se trouvent en section 6.2 du protocole de l'étude.
    E.5 End points
    E.5.1Primary end point(s)
    - The total number of subjects experiencing at least one Treatment Emergent Adverse Event during the study
    - The total number of subjects experiencing at least one Serious Adverse Event during the study
    - Nombre total de patient ayant eu au moins un effet indésirable suite au traitement durant l'étude
    - Nombre total de patient ayant eu au moins un effet indésirable grave durant l'étude
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: Baseline until the end of study
    De la visite de sélection à la fin de l'étude
    E.5.2Secondary end point(s)
    Plasma Concentration of UCB5857
    Concentration plasmatique de l'UCB5857
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time Frame: Baseline until the end of study
    De la visite de sélection à la fin de l'étude
    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 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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability of UCB5857
    Tolérance à l'UCB5857
    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 No
    E.8.1.2Open No
    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 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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    The end of the study is defined as the date of the last visit of the last subject in the study.
    La fin de l'étude est définie comme la date de la dernière visite du dernier patient participant à l'étude.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 3
    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: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3
    F.1.3Elderly (>=65 years) No
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 6
    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)
    According to the clinical trial protocol.
    Selon le protocole de l'étude.
    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 Decision2017-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-13
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