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    Summary
    EudraCT Number:2010-023029-39
    Sponsor's Protocol Code Number:Plerixafor-MM02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-05
    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 number2010-023029-39
    A.3Full title of the trial
    Plerixafor MM02 - Plerixafor plus G-CSF after chemotherapy for the mobilization of Peripheral Blood Stem Cells (PBSCs) in Multiple Myeloma (MM) patients undergoing Autologous Stem Cell Transplantation (ASCT)
    Plerixafor in associazione al fattore di crescita granulocitario (G-CSF) dopo chemioterapia per la mobilizzazione di cellule staminali nel sangue periferico (PBSCs) in pazienti con mieloma multiplo (MM) candidati a trapianto di cellule staminali autologhe (ASCT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Plerixafor MM02 - Plerixafor plus G-CSF after chemotherapy for the mobilization of Peripheral Blood Stem Cells (PBSCs) in Multiple Myeloma (MM) patients undergoing Autologous Stem Cell Transplantation (ASCT)
    Plerixafor in associazione al fattore di crescita granulocitario (G-CSF) dopo chemioterapia per la mobilizzazione di cellule staminali nel sangue periferico (PBSCs) in pazienti con mieloma multiplo (MM) candidati a trapianto di cellule staminali autologhe (ASCT)
    A.3.2Name or abbreviated title of the trial where available
    Plerixafor-MM02
    A.4.1Sponsor's protocol code numberPlerixafor-MM02
    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 SponsorAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    B.1.3.4CountryItaly
    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 supportGenzyme - fornitura gratuita IMP1
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna Policlinico S.Orsola-Malpighi
    B.5.2Functional name of contact pointU.O. Ematologia-PI Prof. Lemoli
    B.5.3 Address:
    B.5.3.1Street AddressVia Albertoni 15
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number051/6363680
    B.5.5Fax number051/6364037
    B.5.6E-mailroberto.lemoli@nibo.it
    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 Mozobil
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    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 INNPLERIXAFOR
    D.3.9.1CAS number 110078-46-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB28849
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 RoleComparator
    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 GRANOCYTE 34*1F 33,6MIU+F 1ML
    D.2.1.1.2Name of the Marketing Authorisation holderITALFARMACO SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder and solvent for 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 INNLENOGRASTIM
    D.3.9.1CAS number 135968-09-1
    D.3.9.4EV Substance CodeSUB02888MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number263
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typefarmaco di natura biologica /ricombinante
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 GRANULOKINE 30*1FL 30MU 1ML
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN DOMPE' SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    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 INNFILGRASTIM
    D.3.9.1CAS number 121181-53-1
    D.3.9.4EV Substance CodeSUB07627MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typefarmaco di natura biologica /ricombinante
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 ENDOXAN BAXTER*INIET 1FL 1G
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    multiple myeloma
    mieloma multiplo
    E.1.1.1Medical condition in easily understood language
    multiple myeloma
    mieloma multiplo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
     Percentage of patients collecting ≥ 6 x 106 CD34+ cells/Kg in three or less apheresis
     Percentuale di pazienti in grado di raccogliere ≥ 6 x 106 cellule CD34+ /Kg in tre o meno di tre procedure aferetiche
    E.2.2Secondary objectives of the trial
     Number of apheresis to collect ≥ 6 x 106 CD34+ cells/Kg
     Evaluation of engraftment after transplantation of plerixafor-mobilized PBSCs
     Evaluation of immunological reconstitution after transplantation
     Evaluation of cellular graft content
     Evaluation of resources consumption and relative direct costs estimation in the management of patients with plerixafor therapy in association with G-CSF after chemotherapy
     Percentage of patients collecting ≥ 4 x 106 CD34+ cells/Kg in three or less apheresis following rescue strategy (plerixafor + G-CSF), and number of apheresis required
     Numero di aferesi necessarie per raccogliere ≥ 6 x 106 cellule CD34+/Kg
     Valutazione dell’attecchimento dopo trapianto di PBSCs mobilizzate con plerixafor
     Valutazione della ricostituzione immunologica dopo trapianto
     Valutazione del tipo di cellule presenti nelle leucoaferesi di cellule staminali
     Valutazione del consumo di risorse sanitarie e stima dei relativi costi diretti nella gestione dei pazienti in terapia con Plerixafor e G-CSF dopo chemioterapia
     Percentuale di pazienti in grado di raccogliere ≥ 4 x 106 cellule CD34+/Kg in tre o meno di tre procedure aferetiche dopo strategia di mobilizzazione di salvataggio con plerixafor + G-CSF, e numero di aferesi necessarie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • MM patients eligible and planned for ASCT according to Istitutional guidelines
    • Age > 18 years
    • Written informed consent
    • Performance Status ≥ 70% (Karnofsky) or ≤ 2 (WHO).
    • White blood cell (WBC) count ≥ 2.5 x 109 /L
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109 /L
    • Platelet count ≥ 100 x 109 /L
    • Serum creatinine at time of enrollment ≤ 2.0 mg/dL
    • Aspartate aminotransferase/serum glutamnic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamnic pyruvic transaminase (ALT/SGPT), and total bilirubin at time of enrollment < 2.5 x upper limit of normal (ULN)
    • Adequate cardiac, renal and pulmonary function to undergo apheresis and transplantation
    • All patients must agree to use highly effective method of contraception while on study treatment and for at least 3 months following plerixafor treatment (including both female patients of child-bearing potential and male patients with partners of child-bearing potential).
    • Pazienti affetti da MM eleggibili e candidati a trapianto autologo secondo le linee guida di ogni Centro partecipante allo studio
    • Età &gt; 18 anni
    • Consenso informato scritto
    • Performance Status ≥ 70% (Karnofsky) o ≤ 2 (WHO).
    • Numero di globuli bianchi (GB) ≥ 2.5 x 109 /L
    • Numero assoluto di granulociti neutrofili (PMN) ≥ 1.5 x 109 /L
    • Numero di piastrine ≥ 100 x 109 /L
    • Creatinina sierica al momento dell’ arruolamento ≤ 2.0 mg/dL
    • Aspartato aminotransferasi/glutamnico ossalacetico transaminasi sierica (AST/SGOT), alanina aminotransferasi/glutamnico piruvico transaminasi sierica (ALT/SGPT), e bilirubina totale al momento dell’ arruolamento &lt; 2.5 volte il limite superiore di normalità (ULN)
    • Funzione cardiaca, renale, polmonare adeguata per essere sottoposto a procedura aferetica e trapianto.
    • Tutti i pazienti devono accettare di utilizzare metodi di contraccezione altamente efficaci durante il trattamento dello studio e per almeno 3 mesi dopo trattamento con plerixafor (sono incluse le pazienti in età fertile e i pazienti con partner fertili).
    E.4Principal exclusion criteria
    • History of any acute or chronic myelogenous leukemia
    • HIV positivity; active Hepatitis B or Hepatitis C
    • Intercurrent organ damage or medical problems that would interfere with therapy.
    • Pregnant or nursing females.
    • Concurrent uncontrolled infection.
    • Previously received investigation therapy within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilization phase
    • Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization
    • Storia di una qualunque leucemia acuta o cronica.
    • Positività nota al virus dell’immunodeficienza acquisita (HIV); epatite B o C attiva
    • Condizioni di comorbidità o problemi clinici intercorrenti che potrebbero interferire con la terapia.
    • Donne gravide o in allattamento.
    • Infezione intercorrente non controllata.
    • Somministrazione di una precedente terapia sperimentale entro 4 settimane dall’arruolamento nel presente protocollo o arruolamento in un altro protocollo sperimentale durante la fase di mobilizzazione.
    • Trattamento con G-CSF o un’altra citochina nei 14 giorni precedenti la prima dose di G-CSF per la mobilizzazione.
    E.5 End points
    E.5.1Primary end point(s)
     Number of CD34+ cells mobilized into PB
     Number of PBSC collections
     Numero di cellule CD34+ mobilizzate nel sangue periferico
     Numero di procedure aferetiche
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
     Number of days to neutrophil and platelet engraftment.
     Kinetic of immunological reconstitution as the number of circulating lymphocytes, CD3+ , CD4+, CD8+, CD19+ , T-reg and CD56+ cells at 30 days, 3,6,9 and 12 months after transplantation.
     Concentration of stem cell and lymphocyte subsets into leukaphereses.
     Type and quantity of medical resources and estimation of relative direct medical costs for plerixafor therapy in association with G-CSF after chemotherapy.
     Numero di giorni per l’attecchimento dei granulociti neutrofili e delle piastrine dopo ASCT.
     Cinetica della ricostituzione immunologica, valutata come numero di linfociti circolanti, cellule CD3+ , CD4+, CD8+, CD19+ , T-reg e CD56+ a 30 giorni, 3,6,9 e 12 mesi dopo ASCT.
     Concentrazione di cellule staminali e sottopopolazioni linfocitarie nell’aferesi
     Tipologia e quantità di risorse e materiale sanitario consumato per la somministrazione di terapia con plerixafor in associazione a G-CSF dopo chemioterapia
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 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 Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    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.1.1Number 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state37
    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)
    NA
    NA
    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 Decision2012-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-15
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