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    Summary
    EudraCT Number:2014-003212-36
    Sponsor's Protocol Code Number:ACE-WM-001
    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:2015-08-06
    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 number2014-003212-36
    A.3Full title of the trial
    An Open-label, Phase 1b/2 Study of ACP-196 in Subjects
    with Waldenström Macroglobulinemia
    Etude ouverte de phase 1b/2 de l'ACP-196 chez des patients atteints d'une Macroglobulinémie de Waldenström
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial to See the Effects of ACP-196 (the test drug) in Patients who have
    Waldenström Macroglobulinemia
    Une étude pour évaluer l'efficacité de l'ACP-196 (médicament testé) chez des patients atteints d'une Macroglobulinémie de Waldenström
    A.4.1Sponsor's protocol code numberACE-WM-001
    A.5.4Other Identifiers
    Name:IND NumberNumber:118717
    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 SponsorAcerta Pharma BV
    B.1.3.4CountryNetherlands
    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 supportAcerta Pharma BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcerta Pharma BV
    B.5.2Functional name of contact pointACE-WM-001 Clincial Team
    B.5.3 Address:
    B.5.3.1Street AddressMolenstraat 110
    B.5.3.2Town/ cityOss
    B.5.3.3Post code5342 CC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+16505912800
    B.5.6E-mailace-wm-001@acerta-pharma.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 nameACP-196
    D.3.2Product code ACP-196
    D.3.4Pharmaceutical form Capsule
    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 INNnot yet assigned
    D.3.9.2Current sponsor codeACP-196
    D.3.9.3Other descriptive nameACP-196
    D.3.9.4EV Substance CodeSUB166233
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Waldenström Macroglobulinemia
    Macroglobulinémie de Waldenström
    E.1.1.1Medical condition in easily understood language
    blood cancer
    Cancer du sang
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10047804
    E.1.2Term Waldenstrom's macroglobulinaemia recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10047805
    E.1.2Term Waldenstrom's macroglobulinaemia refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of ACP-196 in subjects with previously treated
    WM as measured by standard response criteria.
    Déterminer l'efficacité de l'ACP-196 chez des sujets préalablement traités pour une Macroglobulinémie de Walderstrom mesurée par des critères de réponse standard
    E.2.2Secondary objectives of the trial
    • To Evaluate the preliminary efficacy of ACP-196 in subjects with
    previously untreated WM
    • To characterize the PK profile of ACP-196 in both patient populations
    (treated and untreated WM)
    • To evaluate the PD effects of ACP-196 in both patient populations
    (treated and untreated WM)
    • To characterize the safety of ACP-196 in both patient populations
    (treated and untreated WM)
    • To evaluate the effect of ACP-196 in health-related quality of life in
    both patient populations (treated and untreated WM)
    • Evaluer l'efficacité préliminaire de ACP-196 chez des sujets atteints d'un WM non préalablement traité
    • Caractériser la pharmacocinétique de ACP-196 dans les deux populations de patients (WM traité et non traité )
    • Evaluer la pharmacodynamique de ACP-196 dans les deux populations de patients (WM traité et non traité )
    • Caractériser la sécurité de ACP-196 dans les deux populations de patients (WM traité et non traité )
    • Evaluer l'effet de ACP-196 sur la qualité de vie dans
    les deux populations de patients (WM traités et non traités )
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women ≥ 18 years of age.
    2. Previously treated cohort only: A confirmed diagnosis of WM, which
    has relapsed after, or been refractory to ≥ 1 prior therapy for WM and
    which requires treatment
    3. Previously untreated cohort only: A confirmed diagnosis of previously
    untreated WM in subjects who require treatment and do not want to
    receive chemoimmunotherapy or have comorbidities that would preclude chemoimmunotherapy such as:
    • Symptomatic hyperviscosity with an IgM ≥ 5,000 mg/dL
    • Disease-related neuropathy
    4. Serum concentration of IgM, as measured by serum protein
    electrophoresis (SPEP) and immunofixation electrophoresis (IFE), that
    exceeds the upper limits of normal or measurable nodal WM (defined as
    the presence of ≥1 lymph node that measures ≥ 2.0 cm in the longest
    diameter and ≥ 1.0 cm in the longest perpendicular diameter).
    5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤
    2.
    6. Agreement to use acceptable methods of contraception during the
    study and for 30 days after the last dose of study drug if sexually active
    and able to bear or beget children.
    7. Agreement to refrain from sperm donation during the study and for 30 days after the last dose of study drug.
    8. Willing and able to participate in all required evaluations and
    procedures in this study protocol including swallowing capsules without
    difficulty.
    9. Ability to understand the purpose and risks of the study and provide
    signed and dated informed consent and authorization to use protected
    health information (in accordance with national and local subject privacy regulations).
    1. Hommes et femmes ≥ 18 ans
    2. Cohorte préalablement traitée uniquement: diagnostic confirmé de WM, en rechute ou réfractaire à ≥ 1 traitement antérieur pour WM et qui nécessite un traitement
    3. Cohorte non préalablement traité uniquement: diagnostic confirmé d'un WM non traité chez des sujets qui nécessitent un traitement et ne veulent pas recevoir de chimio-immunothérapie ou qui ont des comorbidités qui empêcheraient la chimio-immunothérapie telles que:
    • hyperviscosité symptomatique avec IgM ≥ 5,000 mg / dL
    • neuropathie liée à la maladie
    4. concentration sérique d'IgM, telle que mesurée par électrophorèse de la protéine sérique (SPEP) et électrophorèse d'immunofixation (IFE), supérieure à la limite supérieure du WM nodal normal ou mesurable (définie comme la présence de ≥1 ganglion lymphatique ≥ 2,0 cm dans le plus grand diamètre ≥ 1,0 cm dans le diamètre perpendiculaire).
    5. ECOG ≤2.
    6. Sujets qui acceptent d'utiliser des méthodes efficaces de contraception pendant l'étude et pendant 30 jours après la dernière dose de médicaments à l'étude s'ils sont sexuellement actifs et en âge de procréer.
    7. Pas de don de sperme pendant l'étude et pendant 30 jours après la dernière dose de médicament à l'étude.
    8. Accord et capacité de participer à toutes les évaluations et procédures nécessaires à ce protocole, y compris à avaler des gélules sans difficulté.
    9. Capacité à comprendre l'objectif et les risques de l'étude et de fournir un consentement éclairé daté et signé ainsi que l'autorisation d'utilisation de données protégées sur leur santé (en conformité avec la législation locale et nationale sur la vie privée).
    E.4Principal exclusion criteria
    1. Prior malignancy, except for adequately treated basal cell or
    squamous cell skin cancer, in situ cervical cancer, or other cancer from
    which the subject has been disease free for ≥ 2 years or which will not
    limit survival to < 2 years. Note: these cases must be discussed with the
    Medical Monitor.
    2. A life-threatening illness, medical condition or organ system
    dysfunction which, in the investigator's opinion, could compromise the
    subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk.
    3. Significant cardiovascular disease such as uncontrolled or
    symptomatic arrhythmias, congestive heart failure, or myocardial
    infarction within 6 months of screening, or any Class 3 or 4 cardiac
    disease as defined by the New York Heart Association Functional
    Classification, or left ventricular ejection fraction (LVEF) ≤ 40%, or QTc
    > 480 msec.
    4. Malabsorption syndrome, disease significantly affecting
    gastrointestinal function, or resection of the stomach or small bowel or
    ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
    5. Any immunotherapy within 4 weeks of first dose of study drug.
    6. For subjects with recent chemotherapy or experimental therapy the
    first dose of study drug must occur after 5 times the half-life of the
    agent(s).
    7. Prior exposure to a BCR inhibitor (eg, Btk, phosphoinositide-3 kinase
    [PI3K]]], or Syk inhibitors) or BCL-2 inhibitors (eg, ABT-199).
    8. Ongoing immunosuppressive therapy, including systemic or enteric
    corticosteroids for treatment of WM or other conditions. Note: Subjects
    may use topical or inhaled corticosteroids or low-dose steroids (≤ 10 mg
    of prednisone or equivalent per day) as therapy for comorbid conditions. During study participation, subjects may also receive systemic or enteric corticosteroids as needed for treatment-emergent comorbid conditions.
    9. Grade ≥ 2 toxicity (other than alopecia) continuing from prior
    anticancer therapy including radiation.
    10. Known history of human immunodeficiency virus (HIV) or active
    infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) or any
    uncontrolled active systemic infection.
    11. Major surgery within 4 weeks before first dose of study drug.
    12. Uncontrolled autoimmune hemolytic anemia or idiopathic
    thrombocytopenia purpura.
    13. History of a bleeding diathesis (eg, hemophilia, von Willebrand
    disease).
    14. History of stroke or intracranial hemorrhage within 6 months before
    the first dose of study drug.
    15. Requires or receiving anticoagulation with warfarin or equivalent
    vitamin K antagonists (eg, phenprocoumon) within 28 days of first dose
    of study drug.
    16. Requires treatment with long-acting proton pump inhibitors (eg,
    omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole).
    17. Absolute neutrophil count (ANC) < 0.75 x 109/L or platelet count
    <50 x 109/L. For subjects with disease involvement in the bone marrow,
    ANC < 0.50 x 109/L or platelet count < 30 x 109/L.
    18. Creatinine > 2.5 x institutional upper limit of normal (ULN); total
    bilirubin > 2.5 x ULN; or aspartate aminotransferase (AST) or alanine
    aminotransferase (ALT) > 3.0 x ULN
    19. Lactating or pregnant.
    20. Concurrent participation in another therapeutic clinical trial.
    1. Malignité antérieure, à l'exception des cancers des cellules basales, des cellules squameuse de la peau, du col de l'utérus, traités de manière adéquate ou d'un autre cancer pour lequel le sujet est en rémission depuis au moins 2 ans ou espérance de vie >2 ans. Remarque: ces cas doivent être discutés avec le moniteur médical.
    2. Maladie mortelle, condition médicale ou disfonction systémique d'organe qui, de l'avis de l'investigateur, pourrait compromettre la sécurité du patient, interférer avec l'absorption ou le métabolisme de ACP-196, ou biaiser les résultats de l'étude.
    3. Maladies cardiovasculaires majeures telles que arythmies symptomatiques ou incontrôlées, insuffisance cardiaque congestive, ou infarctus du myocarde dans les 6 mois du screening, ou maladie cardiaque de catégorie 3 ou 4 telle que définie par la New York Heart Association Functional Classification ou une fraction d'éjection ventriculaire gauche ≤ 40%, ou QTc > 480 msec.
    4. Syndrome de malabsorption, maladie affectant significativement la fonction gastro-intestinale, ou résection de l'estomac ou de l'intestin grêle, dérivation gastrique, maladie intestinale inflammatoire symptomatique ou partielle ou obstruction complète de l'intestin.
    5. Toute immunothérapie dans les 4 semaines précédant la première dose de médicament à l'étude.
    6. Pour les sujets traités avec une récente chimiothérapie ou une chimiothérapie experimentale, la première dose du médicament de l'étude doit être administrée après 5 fois la demi-vie de(s) l'agent(s).
    7. Exposition antérieure à un inhibiteur de BCR (par exemple, les inhibiteurs de Btk, PI3K ou Syk) ou inhibiteur BCL-2 (par ex ABT-199).
    8. Traitement immunosuppresseur en cours, y compris corticoïdes systémiques ou entériques pour le traitement de MCL ou autre. Remarque: les sujets peuvent utiliser des corticostéroïdes topiques ou inhalés ou des stéroïdes à faible dose (≤ 10 mg de prednisone ou équivalent par jour) en traitement de comorbidités. Au cours de l'étude, les sujets peuvent également recevoir des corticostéroïdes systémiques ou entériques pour le traitement des comorbidités émergentes
    9. Toxicité de grade ≥ 2 (autre que l'alopécie) des suites d'une thérapie anticancéreuse précédente, comprenant la radiothérapie
    10. Infection par le virus de l'immunodéficience humaine (VIH) ou infection active par le virus de l'hépatite C (VHC) ou le virus de l'hépatite B (VHB) ou toute infection active systémique incontrôlée.
    11. Chirurgie majeure dans les 4 semaines avant la première dose de médicament à l'étude.
    12. Anémie hémolytique auto-immune non contrôlée ou purpura thrombocytopénique idiopathique.
    13. Antécédents de diathèse hémorragique (par ex hémophilie, maladie de Willebrand)
    14. Antécédents d'accident vasculaire cérébral ou d'hémorragie intracrânienne dans les 6 mois avant la première dose de médicament à l'étude.
    15. Nécessité d'anticoagulation avec warfarine ou AVK (par ex phenprocoumon) dans les 28 jours avant la première dose du médicament à l'étude.
    16. Nécessité d'un traitement avec inhibiteurs de pompe à proton à longue durée d'action (par ex oméprazole, ésoméprazole, lansoprazole, dexlansoprazole, rabéprazole, ou pantoprazole)
    17. ANC < 0.75 x 109/L ou numération plaquettaire < 50 x 109/L; pour les patients avec un développement de la maladie vers la moelle épinière ANC < 0.50 x 109/L ou numération plaquettaire < 30 x 109/L
    18. créatinine > 2,5 x la limite normale supérieure (LNS); bilirubine totale > 2,5 x LNS (sauf en cas de la maladie de Gilbert); et aspartate aminotransférase (ASAT) ou alanine aminotransférase (ALT)> 2,5 x LNS sauf si lié à la maladie.
    19. Femmes enceintes ou qui allaitent
    20. Participation simultanée à un autre essai clinique thérapeutique.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the overall response rate (ORR)
    defined as a subject achieving a minor response or better according to the Response Assessment Criteria for WM as assessed by investigators
    Le critère d'évaluation principal de l'étude est le taux de réponse global (ORR) défini comme un sujet présentant une réponse mineure ou une amélioration selon les critères d'évaluation de réponse pour le WM tel qu'évalué par les investigateurs
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 30 days after stopping study treatment
    après 30 jours après l'arrêt du traitement à l'étude
    E.5.2Secondary end point(s)
    Efficacy:
    • duration of overall response (DOR)
    • progression-free survival (PFS)
    • overall survival (OS)

    Safety:
    • frequency, severity, and relatedness of adverse events (AEs)
    • frequency of adverse events requiring discontinuation of study drug or
    dose reductions
    • effect of ACP-196 on peripheral T/B/NK cell counts
    • effect of ACP-196 on serum immunoglobulin levels

    Pharmacokinetics:
    • plasma pharmacokinetics of ACP-196

    Patient Reported Outcomes (PRO):
    • health-related quality of life

    Efficacité:
    • durée de la réponse totale (DOR)
    • survie sans progression (PFS)
    • survie globale (OS)

    Sécurité:
    • fréquence, gravité et relation des événements indésirables
    • fréquence des événements indésirables nécessitant l'arrêt du médicament à l'étude ou la réduction de la dose
    • effet de ACP-196 sur le nombre de cellules T / B / NK périphériques
    • effet de ACP-196 sur les niveaux sériques d'immunoglobulines

    Pharmacocinétique:
    • pharmacocinétiques plasmatiques de ACP-196

    Patient Reported Outcomes (PRO):
    • qualité de vie liée à la santé
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 30 days after stopping study treatment
    après 30 jours après l'arrêt du traitement à 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 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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety and Efficacy Profile
    Profil de sécurité et d'efficacité
    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 No
    E.8.1.1Randomised No
    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 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 trial1
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Australia
    Austria
    France
    Greece
    Italy
    Netherlands
    Spain
    United Kingdom
    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
    LVLS
    Dernière visite du dernier patient
    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 months6
    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 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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 88
    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 defined
    aucun défini
    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 Decision2015-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-31
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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