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    Summary
    EudraCT Number:2012-003457-28
    Sponsor's Protocol Code Number:CC-486-AML-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-12-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-003457-28
    A.3Full title of the trial
    A phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission
    Studio di fase 3, randomizzato, in doppia cecita', controllato con placebo, che si propone di confrontare l'efficacia e la sicurezza dell'azacitidina orale, somministrata insieme alla miglior terapia di supporto, versus la migliore terapia di supporto come trattamento di mantenimento a soggetti con leucemia mieloide acuta che hanno raggiunto una riposta completa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects with Acute Myeloid Leukemia (AML) no longer experiences symptoms of the disease
    Efficacia e sicurezza di azacitidina orale, somministrata insieme alla miglior terapia di supporto, verso placebo somministrato insieme alla migliore terapia di supporto, in soggetti con leucemia mieloide acuta (AML) che non presentano più i sintomi della malattia
    A.3.2Name or abbreviated title of the trial where available
    QUAZAR AML maintenance
    QUAZAR AML mantenimento
    A.4.1Sponsor's protocol code numberCC-486-AML-001
    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 SponsorCELGENE CORPORATION
    B.1.3.4CountryUnited States
    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 supportCelgene Corporatiron
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9900 W. 109th Street, Suite 300, Building 70, Overland Park,
    B.5.3.2Town/ cityKansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 888 2601599
    B.5.5Fax number+1 913 4513459
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/509
    D.3 Description of the IMP
    D.3.1Product nameOral Azacitidine
    D.3.2Product code CC-486
    D.3.4Pharmaceutical form Film-coated 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 INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/509
    D.3 Description of the IMP
    D.3.1Product nameOral Azacitidine
    D.3.2Product code CC-486
    D.3.4Pharmaceutical form Film-coated 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 INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myeloid leukemia in complete remission
    Leucemia Mieloide Acuta in remissione completa
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia (AML) no longer experiences symptoms of the disease
    Leucemia Mieloide Acuta che non manifesta più i sintomi della malattia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000881
    E.1.2Term Acute myeloid leukaemia (in remission)
    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
    The primary objective of the study is to demonstrate if maintenance therapy with oral azacitidine improves OS compared with placebo in subjects with AML, age ≥55 years, who have achieved first CR or CRi after induction with intensive chemotherapy with or without consolidation chemotherapy
    L'obiettivo primario dello studio è dimostrare se la terapia di mantenimento con azacitidina orale migliora la sopravvivenza globale (Overall Survival - OS) rispetto al placebo nei soggetti con LAM, di età superiore o uguale a 55 anni, che hanno raggiunto la prima remissione completa (RC) o la remissione completa con recupero ematologico incompleto (RCi) dopo la chemioterapia intensiva di induzione con o senza chemioterapia di consolidamento.
    E.2.2Secondary objectives of the trial
    - To determine safety, tolerability; and - To determine the effect of oral azacitidine compared with placebo on HRQoL and healthcare resource utilization. Exploratory objectives: - To determine complete cytogenetic remission rate; - To evaluate molecular and/or cellular markers in the bone marrow post-induction and during maintenance therapy that may be predictive of clinical outcomes with therapy (placebo or oral azacitidine), including OS and RFS, following CR/CRi; and - To evaluate exploratory HRQoL measures.
    •determinare la sopravvivenza senza ricadute di malattia (Relapse Free Survival - RFS); •determinare la sicurezza e tollerabilità e •determinare l'effetto di azacitidina orale rispetto al placebo sulla qualità della vita in relazione alle condizioni di salute (HRQoL) e sull'utilizzo di risorse mediche. Obiettivi esplorativi: •determinare il tasso di remissione citogenetica completa (RCc); •valutare i marcatori molecolari e/o cellulari nel midollo osseo dopo la terapia di induzione e durante la terapia di mantenimento, che potrebbero essere predittivi dei risultati clinici della terapia (placebo o azacitidina orale), compresi la sopravvivenza globale (OS) e la sopravvivenza senza ricadute di malattia (RFS), dopo la remissione completa/ remissione completa con recupero ematologico incompleto RC/RCi; e •valutare le misure HRQoL esplorative
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects ≥55 years of age at the time of signing the ICD; 2. Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior myelodysplastic disease; 3. Should have undergone induction therapy with intensive chemotherapy with or without consolidation therapy; 4. Should have achieved first CR/CRi status within 3 months prior to randomization; 5. ECOG performance status of 0, 1, 2 or 3; 6. Adequate bone marrow function based on ANCs ≥ 0.5 x 109/L and platelet counts ≥ 20,000 x 109/L; 7. Adequate organ function, defined as: • Serum bilirubin ≤1.5 times the upper limit of normal; • Serum aspartate aminotransferase and alanine aminotransferase ≤2.5 times the ULN; • Serum creatinine ≤ 2.5 times the ULN; 8. FCBP may participate, providing they meet the following conditions: • Agree to practice abstinence; or • Agree to use at least two effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study, and for 3 months following the last dose of oral azacitidine; and • Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at screening; and • Have a negative serum or urine pregnancy test (Investigator's discretion) within 72 hours prior to starting study therapy in the doubleblind treatment phase (note that the screening serum pregnancy test can be used as the test prior to starting study therapy in the doubleblind treatment phase if it is performed within the 72 hour timeframe); 9. Male subjects with a female partner of childbearing potential must agree to practice abstinence or to the use of a physician-approved contraceptive method throughout the course of the study and avoid fathering a child during the course of the study and for 3 months following the last dose of azacitidine.
    1. Uomini o donne di età ≥ 55 anni al momento della firma del modulo di consenso informato 2. Nuova diagnosi, confermata istologicamente di LAM o LAM secondaria a una precedente sindrome mielodisplastica 3. Precedente terapia di induzione con chemioterapia intensiva con o senza terapia di consolidamento 4. Raggiungimento della prima RC/RCi entro i 3 mesi precedenti la randomizzazione 5. Performance Status secondo ECOG pari a 0, 1, 2 o 3; 6. Funzionalità del midollo osseo adeguata definita da una conta assoluta dei neutrofili ANC ≥ 0,5 x 109/l e da un numero di piastrine ≥ 20.000 x 109/l 7. Funzionalità degli organi adeguata, definita come: • bilirubina nel siero ≤ 1,5 volte il limite superiore della norma (ULN); • aspartato aminotransferasi (AST) e alanina aminotransferasi (ALT) nel siero ≤ 2,5 x ULN; • creatinina nel siero ≤ 2,5 x ULN. 8. Le donne potenzialmente fertili (FCBP) possono partecipare, a condizione che soddisfino i requisiti seguenti: • consenso a praticare l'astinenza; • consenso ad utilizzare almeno due metodi contraccettivi efficaci (contraccettivo ormonale orale, iniettabile o impiantabile; legatura delle tube; dispositivo intrauterino; contraccettivo di barriera con spermicida o partner vasectomizzato) nel corso dello studio e per 3 mesi dopo l’assunzione dell'ultima dose di azacitidina orale; e • avere un test di gravidanza sul siero negativo (sensibilità di almeno 25 mIU/mL) allo screening; e • fare un test di gravidanza sul siero o sulle urine che deve risultare negativo (a discrezione dello Sperimentatore) entro le 72 ore precedenti l'inizio della terapia sperimentale nella fase di trattamento in doppio cieco (il test di gravidanza sul siero allo screening può essere usato come test prima dell'inizio della terapia sperimentale nella fase di trattamento in doppio cieco se eseguito entro la finestra temporale delle 72 ore). 9. I soggetti di sesso maschile con partner di sesso femminile potenzialmente fertile devono accettare di praticare l'astinenza o usare un metodo contraccettivo approvato dal medico per l'intera durata dello studio ed evitare di concepire un figlio per l'intero corso dello studio e nei 3 mesi successivi l’assunzione dell'ultima dose di azacitidina
    E.4Principal exclusion criteria
    1. Suspected or proven acute promyelocytic leukemia (FAB M3) based on morphology, immunophenotype, molecular assay, or karyotype; or AML with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding MDS; 2. AML associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations; 3. Prior bone marrow or stem cell transplantation; 4. Have achieved CR/CRi following therapy with hypomethylating agents; 5. Received therapy with hypomethylating agents for MDS and went on to develop AML within four months of discontinuing the therapy with hypomethylating agents; 6. Proven central nervous system leukemia; 7. Candidate for allogeneic bone marrow or stem cell transplant at screening; 8. Diagnosis of malignant disease within the previous 12 months (excluding basal cell carcinoma of the skin without complications, ''insitu'' carcinoma of the cervix or breast, or other local malignancy excised or irradiated with a high probability of cure); 9. Unstable angina, significant cardiac arrhythmia, or New York Heart Association class 3 or 4 congestive heart failure 10. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment); 11. Known active viral infection with known human immunodeficiency virus or viral hepatitis type B or C ;12. Known or suspected hypersensitivity to azacitidine or mannitol; 13. Use of any other experimental drug or therapy within 28 days prior to Day 1 of Cycle 1.
    1. Leucemia promielocitica acuta dimostrata o sospetta (FAB M3) in base alla morfologia, l’immunofenotipizzazione, l’esame molecolare o il cariotipo; oppure LAM successiva ad una precedente malattia ematologica come leucemia mieloide cronica o neoplasia mieloproliferativa, tranne la SMD 2. LAM associata a cariotipi inv (16), t(8;21), t(16;16), t(15;17) o t(9;22) oppure evidenza molecolare di tali traslocazioni 3. Precedente trapianto di midollo osseo o di cellule staminali 4. Raggiungimento di RC/RCi dopo terapia con agenti ipometilanti 5. Somministrazione di una terapia con agenti ipometilanti per il trattamento della SMD e sviluppo di LAM entro quattro mesi dall'interruzione della terapia con agenti ipometilanti 6. Leucemia con documentato coinvolgimento del sistema nervoso centrale 7. Pazienti candidabili al trapianto di midollo osseo allogenico o di cellule staminali al momento dello screening 8. Diagnosi di neoplasia nei 12 mesi precedenti (tranne carcinoma a cellule basali della pelle senza complicazioni, carcinoma ''in-situ'' della cervice o della mammella o altra neoplasia localizzata asportata chirurgicamente o irradiata con elevata probabilità di cura) 9. Angina instabile, aritmia cardiaca significativa o insufficienza cardiaca congestizia di classe 3 o 4 secondo la New York Heart Association (NYHA) 10. Infezione batterica, micotica o virale sistemica non controllata (definita come presenza di segni/sintomi correlati all'infezione non migliorati nonostante una terapia antibiotica appropriata e/o altro trattamento) 11. Infezione nota da virus dell’immunodeficienza umana (HIV) o virus dell'epatite B (HBV) o C (HCV); 12. Ipersensibilità nota o sospetta ad azacitidina o mannitolo 13. Uso di un qualunque altro farmaco o terapia sperimentale nei 28 giorni precedenti il Giorno 1 del Ciclo 1.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival
    Sopravvivenza Globale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Estimated at 60 months after study initiation (approx. 330 deaths in total)
    Stimata a 60 mesi dopo l'inizio dello studio (circa 330 morti in totale)
    E.5.2Secondary end point(s)
    - RFS; -Time to relapse from CR/CRi; -Time to discontinuation from treatment; -Safety / tolerability (type, frequency, severity, and relationship of AEs to study treatments; physical examinations, vital signs; clinical laboratory evaluations, and concomitant medication/therapy); - Patient-reported outcomes utilizing the FACIT-Fatigue Scale and the EQ-5D; and - Measures of healthcare resource utilization
    - RFS; - l'intervallo trascorso prima della ricaduta da CR/CRi; -, l'intervallo trascorso prima dell'interruzione del trattamento; -Sicurezza / tollerabilità (tipo, frequenza, gravità, e relazione tra gli eventi avversi e i trattamenti dello studio; esami fisici, segni vitali; esami clinici di laboratorio, farmaci/ terapia concomitanti); - Questionari per il paziente utilizzando la scala FACIT-Fatigue ed lo EQ-5D, e - Misure dell'utilizzo delle risorse sanitarie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Estimated at 60 months after study initiation (approx. 330 deaths in total)
    Stimata a 60 mesi dopo l'inizio dello studio (circa 330 morti in totale)
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 Yes
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Israel
    Korea, Republic of
    Mexico
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will conclude once the total number of events (n=330 deaths) have occurred.
    Lo studio si concluderà quando il numero totale di eventi (n=330 morti)sarà raggiunto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months58
    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 No
    F.1.1Number of subjects for this age range: 0
    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: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 345
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 460
    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)
    Standard of care
    Terapia standard
    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 Decision2013-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-17
    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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