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    Summary
    EudraCT Number:2016-000500-29
    Sponsor's Protocol Code Number:P150911
    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:2016-04-26
    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 number2016-000500-29
    A.3Full title of the trial
    A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia
    Essai randomisé en cross over comparant la PTH(1-34) recombinante humaine à l’association alfacalcidol-hydrochlorothiazide dans le traitement de l’hypocalcémie autosomique dominante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia
    Essai croisé randomisé comparant la PTH (1-34) recombinante humaine à l'association alfacalcidol/hydrochlorothiazide dans le traitement de l'hypocalcémie autosomique dominante
    A.3.2Name or abbreviated title of the trial where available
    ACTICAS
    A.4.1Sponsor's protocol code numberP150911
    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 - HOPITAUX 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailkarine.goude@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 FORSTEO-R
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V
    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.3.1Product nameFORSTEO-R
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTériparatide
    D.3.9.1CAS number 52232-67-4
    D.3.9.3Other descriptive nameFORSTEO-R
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 µg
    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 Yes
    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 ESIDREX-R 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMA SAS
    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.3.1Product nameESIDREX-R 25 mg
    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 INNHydrochlorothiazide
    D.3.9.1CAS number 58-93-5
    D.3.9.3Other descriptive nameESIDREX-R
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 mg
    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 Yes
    D.2.1.1.1Trade name UN-ALPHA-R 0.25µg
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRES LEO
    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.3.1Product nameUN-ALPHA-R 0.25µg
    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 INNAlfacalcidol
    D.3.9.1CAS number 41294-56-8
    D.3.9.3Other descriptive nameUN-ALPHA-R
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,25 µg
    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
    Autosomal dominant hypocalcemia (ADH)
    Hypocalcémie autosomique dominante (HAD)
    E.1.1.1Medical condition in easily understood language
    Autosomal dominant hypocalcemia (ADH)
    Hypocalcémie autosomique dominante (HAD)
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10021041
    E.1.2Term Hypoparathyroidism
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the non-inferiority on serum calcium of 40 µg rhPTH(1-34) to the combination of 25 mg hydrochlorothiazide/0.5 µg alfacalcidol
    Evaluer la non-infériorité sur la calcémie de 40 µg de rhPTH (1-34) à la combinaison 25 mg d'hydrochlorothiazide/0,5 µg alfacalcidol
    E.2.2Secondary objectives of the trial
    - To assess the impact of treatments on urinary calcium (plasma calcium concentrations as well as glomerular filtration rate are needed to interpret urinary excretion of calcium)
    - To assess the safety of the two therapeutic approaches including the biological tolerance to treatments and hypercalciuria
    - To assess the risk of stone formation
    - To assess the impact on clinical symptoms of hypoparathyroidism
    - To assess specifically the impact of the treatment on the quality of life and cognitive functions
    - Evaluer l'impact des traitements sur la calciurie (la calcémie et le débit de filtration glomérulaire seront nécessaires pour interpréter l'excrétion urinaire de calcium)
    - Evaluer la sécurité des deux approches thérapeutiques y compris la tolérance biologique aux traitements et l'hypercalciurie
    - Evaluer le risque de formation de calculs
    - Evaluer l'impact sur les symptômes cliniques de l'hypoparathyroïdie
    - Evaluer plus précisément l'impact du traitement sur la qualité des fonctions vitales et cognitives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged from 18 to 80 years, of both sexes
    - With genetically proven ADH type 1 (CASR activating mutation)
    - Affiliated to a French health insurance system, and who have consented to the study
    - Patients âgés de 18 à 80 ans, des deux sexes
    - Avec une HAD génétiquement prouvée de type 1
    - Affiliés à un système d'assurance de santé français, et ayant consenti à l'étude
    E.4Principal exclusion criteria
    - Women of childbearing age without contraception
    - For men aged from 18 to 20 years, presence of cartilage of growth on X-ray of left knee
    - Estimated GFR (MDRD) <30 ml/min/1.73 m2
    - Hypokalemia (<3.5 mmol/l) without diuretic therapy
    - Hyponatremia (<135 mmol/l) without diuretic therapy,
    - Long QT interval,
    - Severe hypomagnesemia (? 0.5 mmol/l)
    - Vitamin D deficiency (25OH vit D < 20 ng/mL)
    - Intolerance to sulfamide
    - Gluten intolerance
    - Hepatic failure
    - Bone break history within the three previous months
    - History of radiotherapy of the skeleton
    - History of bone cancer or metastasis
    - Unexplained increase in alkaline phosphatase (>2N)
    - Intolerance to amiloride or other component of the drug
    - Association to other potassium sparing diuretics
    - Femmes en âge de procréer sans contraception
    - Pour les hommes âgés de 18 à 20 ans, présence de cartilage de croissance sur la radiographie du genou gauche
    - DFG estimé (MDRD) <30 ml/min/1,73 m2
    - Hypokaliémie (<3,5 mmol/l) sans traitement diurétique
    - Hyponatrémie (<135 mmol/l) sans traitement diurétique,
    - QT long,
    - Hypomagnésémie sévère (? 0,5 mmol / l)
    - Carence en vitamine D (25OH vitamine D <20 ng/ml)
    - Intolérance au sulfamide
    - Intolérance au gluten
    - Insuffisance hépatique
    - ATCD de fracture osseuse dans les trois mois
    - ATCD de radiothérapie du squelette
    - ATCD de cancer des os ou des métastases
    - Augmentation inexpliquée de la phosphatase alcaline (> 2N)
    - L'intolérance à l'amiloride ou à un autre composant du médicament
    - Association à d'autres diurétiques épargneurs de potassium
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint : ionized serum calcium level measured at two months of treatment by rhPTH(1-34) versus ionized serum calcium level measured at two months of treatment by an association alfacalcidol/hydrochlorothiazide

    Secondary endpoints :
    - Ambulatory measurement of serum calcium level at days 7 an 28 of treatment by rhPTH(1-34) and association alfacalcidol/hydrochlorothiazide and at day 14 of non-treatment periods (run in, wash out, run out).
    - 24h-urinary calcium excretion (expressed as mmol/24h and mmol/mmol creatinine) at every visit
    - Plasma calcium x phosphate product
    - Tolerance of thiazides and amiloride : blood pressure, serum sodium, potassium and creatinine concentration (and estimated GFR by MDRD formulae); plasma renin and aldosterone concentrations; 24h-urinary sodium, potassium and aldosterone excretions
    - Plasma 25 OH vitamin D, 1,25(OH)2 vitamin D concentrations
    - Serum magnesium concentration and 24h-urinary magnesium excretion
    - For assessment of stone formation risk : calcium/citrate and calcium/creatinine ratios measured on spot urines, and cristaluria : number of crystals, type of crystals.
    - For evaluation of the impact of rhPTH(1-34) on bone: alkaline phosphatase measured at every visit
    - Tolerance criteria : number of episodes of cramps, paresthesia, tetany or seizures,
    - Other adverse events
    - Quality of Life (self-administered questionnaire SF36)
    Critère d'évaluation primaire : calcémie ionisée mesurée à deux mois de traitement par PTH (1-34) par rapport à la calcémie ionisée mesurée à deux mois de traitement par l'association alfacalcidol/ hydrochlorothiazide

    Critères d'évaluation secondaires :
    - Mesure ambulatoire de la calcémie aux jours 7 et 28 du traitement par rhPTH(1-34) et par l'association alfacalcidol/hydrochlorothiazide ; et aux jours 14 des périodes sans traitement à l'étude (run in, wash out et run out).
    - Excrétion urinaire de calcium sur 24h (mmol/24h et mmol/mmol de créatinine) à chaque visite
    - produit phosphato-calcique plasmatique
    - Tolérance des diurétiques thiazidiques et amiloride : pression artérielle, natrémie, kaliémie, créatininémie, DFG estimé (MDRD) ; concentrations de rénine et d'aldostérone plasmatiques; excrétion urinaire de sodium, potassium, créatinine et d'aldostérone
    - 25 OH vitamine D, 1,25 (OH) 2 vitamine D plasmatiques
    - Magnésémie et excrétion urinaire par 24h de magnésium
    - Evaluation du risque de formation de calculs : rapports calcium/citrate et calcium/créatinine sur spot urinaires à jeun, et cristalurie: nombre de cristaux, type de cristaux.
    - Evaluation de l'impact de la rhPTH (1-34) sur l'os : phosphatase alcaline mesurée à chaque visite.
    - Critères de tolérance : nombre d'épisodes de crampes, paresthésie, tétanie ou de convulsions
    - Autres événements indésirables
    - Qualité de vie (auto questionnaire SF36)
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months
    2 mois
    E.5.2Secondary end point(s)
    - Ambulatory measurement of serum calcium level at days 7 an 28 of treatment by rhPTH(1-34) and association alfacalcidol/hydrochlorothiazide and at day 14 of non-treatment periods (run in, wash out, run out).
    - 24h-urinary calcium excretion (expressed as mmol/24h and mmol/mmol creatinine) at every visit
    - Plasma calcium x phosphate product
    - Tolerance of thiazides and amiloride : blood pressure, serum sodium, potassium and creatinine concentration (and estimated GFR by MDRD formulae); plasma renin and aldosterone concentrations; 24h-urinary sodium, potassium and aldosterone excretions
    - Plasma 25 OH vitamin D, 1,25(OH)2 vitamin D concentrations
    - Serum magnesium concentration and 24h-urinary magnesium excretion
    - For assessment of stone formation risk : calcium/citrate and calcium/creatinine ratios measured on spot urines, and cristaluria : number of crystals, type of crystals.
    - For evaluation of the impact of rhPTH(1-34) on bone: alkaline phosphatase measured at every visit
    - Tolerance criteria : number of episodes of cramps, paresthesia, tetany or seizures,
    - Other adverse events
    - Quality of Life (self-administered questionnaire SF36)
    - Mesure ambulatoire de la calcémie aux jours 7 et 28 du traitement par rhPTH(1-34) et par l'association alfacalcidol/hydrochlorothiazide ; et aux jours 14 des périodes sans traitement à l'étude (run in, wash out et run out).
    - Excrétion urinaire de calcium sur 24h (mmol/24h et mmol/mmol de créatinine) à chaque visite
    - produit phosphato-calcique plasmatique
    - Tolérance des diurétiques thiazidiques et amiloride : pression artérielle, natrémie, kaliémie, créatininémie, DFG estimé (MDRD) ; concentrations de rénine et d'aldostérone plasmatiques; excrétion urinaire de sodium, potassium, créatinine et d'aldostérone
    - 25 OH vitamine D, 1,25 (OH) 2 vitamine D plasmatiques
    - Magnésémie et excrétion urinaire par 24h de magnésium
    - Evaluation du risque de formation de calculs : rapports calcium/citrate et calcium/créatinine sur spot urinaires à jeun, et cristalurie: nombre de cristaux, type de cristaux.
    - Evaluation de l'impact de la rhPTH (1-34) sur l'os : phosphatase alcaline mesurée à chaque visite.
    - Critères de tolérance : nombre d'épisodes de crampes, paresthésie, tétanie ou de convulsions
    - Autres événements indésirables
    - Qualité de vie (auto questionnaire SF36)
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 months
    8 mois
    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 No
    E.6.5Efficacy No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State 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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned 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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 2016-04-26. 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 state25
    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
    Aucun
    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 Decision2016-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-28
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    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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