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    Summary
    EudraCT Number:2012-004092-40
    Sponsor's Protocol Code Number:CAMN107I2201
    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:2013-01-11
    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 number2012-004092-40
    A.3Full title of the trial
    A single-arm, multicenter, nilotinib treatment-free remission study in patients with BCR-ABL1 positive Chronic Myelogenous Leukemia in chronic phase who have achieved durable minimal residual disease (MRD) status on first line nilotinib treatment
    Studio multicentrico, a braccio singolo, sulla remissione libera dal trattamento con nilotinib in pazienti con Leucemia Mieloide Cronica BRC-ABL1 positiva in fase cronica, che hanno raggiunto uno stato duraturo di malattia minima residua con il trattamento di prima linea con nilotinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical research study evaluating the possibility to suspend the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients who have very small amount of leukemia cells remaining after nilotinib (Tasigna) treatment.
    Studio clinico per valutare la posibilità di sospendere il medicinale nilotinib (Tasigna) in pazienti con leucemia mieloide cronica (LMC) che hanno un minimo residuo di cellule leucemiche dopo il trattamento con nilotinib (Tasigna).
    A.4.1Sponsor's protocol code numberCAMN107I2201
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMA
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityORIGGIO
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number02-96541
    B.5.5Fax number02-9659066
    B.5.6E-mailinfo.studiclinici@novartis.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 Yes
    D.2.1.1.1Trade name TASIGNA*112CPS 150MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/375
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNILOTINIB
    D.3.9.1CAS number 641571-10-0
    D.3.9.2Current sponsor codeAMN107
    D.3.9.4EV Substance CodeSUB25225
    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 Yes
    D.2.1.1.1Trade name TASIGNA*112CPS 200MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/375
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNILOTINIB
    D.3.9.1CAS number 641571-10-0
    D.3.9.2Current sponsor codeAMN107
    D.3.9.4EV Substance CodeSUB25225
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients treated with a planned dose of nilotinib 300 mg BID (or at a reduced dose level of 400 mg QD if required from the perspective of tolerance) for a minimum of 2 calendar years for newly diagnosed BCRABL positive Chronic Myelogenous Leukemia in chronic phase and have achieved MR 4.5 (BCR-ABL ≤ 0.0032% IS) at any time point before being enrolled in the study
    Pazienti adulti trattati con una dose pianificata di 300 mg BID di nilotinib (o con un livello di dosaggio ridotto di 400 mg QD se richiesto dal punto di vista della tollerabilità) per un minimo di 2 anni di calendario per i pazienti con Leucemia Mieloide Cronica BCR-ABL positiva di nuova diagnosi che hanno raggiunto MR 4.5 (BCR-ABL ≤ 0.0032% IS) al momento del pre-screening
    E.1.1.1Medical condition in easily understood language
    Adult patients with CML who have been treated with nilotinib (Tasigna) for at least two years and who have achieved a certain level of molecular response prior to study entry.
    Pazienti adulti con LMC trattati con nilotinib (Tasigna) per almeno 2 anni che hanno raggiunto un certo livello di risposta molecolare prima di entrare nello studio
    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 LLT
    E.1.2Classification code 10054352
    E.1.2Term Chronic phase chronic myeloid leukemia
    E.1.2System Organ Class 100000004864
    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 percentage of patients who are in Major Molecular Response (MMR) at 48 weeks after starting the treatment-free remission (TFR) phase (patients who required re-initiation of treatment will be considered as non-responders)
    Determinare la percentuale di pazienti che sono in MMR a 48 settimane dopo aver iniziato la fase di remissione libera dal trattamento (TFR) (i pazienti che richiedono la ripresa del trattamento saranno considerati come non-rispondenti).
    E.2.2Secondary objectives of the trial
    1) To determine the percentage of patients who are in MR4.5 (BCR-ABL ≤ 0.0032% IS) at 48 weeks after starting the TFR phase (patients who required re-initiation of treatment will be considered as non-responders) 2) To determine the percentage of patients who are in MMR at 96, 144 and 192 weeks after starting the TFR phase (patients who required reinitiation of treatment will be considered as non-responders) 3) To determine the percentage of patients who are in MR4.5 at 96, 144 and 192 weeks after starting the TFR phase (patients who required reinitiation of treatment will be considered as non-responders) 4) To determine the percentage of patients who achieve MMR within 12 weeks of re-treatment with nilotinib 5) To estimate the duration of re-initiated treatment required to regain MMR after loss of MMR Additional objectives apply
    1. Determinare la percentuale di pazienti che sono in MR4.5 (BCR-ABL ≤ 0.0032% IS) a 48 settimane dopo l’inizio della fase TFR (i pazienti che richiedono la ripresa del trattamento saranno considerati come non-rispondenti). 2.Determinare la percentuale di pazienti che sono in MMR a 96, 144 e 192 settimane dopo l’inizio della fase TFR (i pazienti che richiedono la ripresa del trattamento saranno considerati come non-rispondenti). 3.Determinare la percentuale di pazienti che sono in MR4.5 a 96, 144 e 192 settimane dopo l’inizio della fase TFR (i pazienti che richiedono la ripresa del trattamento saranno considerati come non-rispondenti). 4.Determinare la percentuale di pazienti che ottengono la MMR entro 12 settimane dalla ripresa del trattamento con nilotinib. 5.Stimare la durata del trattamento, dopo la ripresa, necessaria per ottenere nuovamente la MMR dopo la perdita di MMR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female patients ≥18 years of age 2) Minimum of 2 calendar years of nilotinib treatment (300 mg BID or transiently lower dose of nilotinib from the perspective of tolerance) for BCR-ABL positive CML in documented chronic phase at the time of diagnosis 3) Evidence of typical BCR-ABL transcripts (b3a2 or b2a2) at the time of CML diagnosis i.e. prior to first start of TKI treatment which are amenable to standardized RT-PCR quantification'' 4) Patient in MR4.5 at prescreening at Novartis designated lab 5) ECOG performance status of 0-2 6) Adequate end organ function as defined by: • Direct bilirubin ≤ 1.5 x ULN • SGOT(AST) and SGPT(ALT) ≤ 3 x ULN i.e. equivalent to ≤ Grade 1 NCICTCAE v.4.03 • Serum lipase ≤ 2 x ULN i.e. equivalent to ≤ Grade 2 NCI-CTCAE v.4.03 • Alkaline phosphatase ≤ 2.5 x ULN • Serum creatinine < 1.5 x ULN 7) Patients must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication: • Potassium (suggested keep to prevent issues with QT and/or rhythm abnormalities) • Magnesium (suggested keep to prevent issues with QT and/or rhythm abnormalities) • Total calcium (corrected for serum albumin) 8) Patients must have normal marrow function as defined: • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L • Hemoglobin ≥ 9.0 g/dL • Platelets ≥ 100 x 109/L Additional inclusion criteria are defined in the protocol.
    -Pazienti di sesso maschile o femminile di età ≥ 18 anni. -Trattamento con nilotinib (300 mg BID o livello di dosaggio ridotto a 400 mg QD se richiesto dal punto di vista della tollerabilità) per un minimo di 2 anni di calendario per leucemia mieloide cronica BCR-ABL positiva in fase cronica documentata al momento della diagnosi. -Evidenza di trascritti BCR-ABL tipici (b3a2 o b2a2) al momento della diagnosi di leucemia mieloide cronica, ovvero prima dell’inizio del primo trattamento con TKI, che sono idonei alla quantificazione RT-PCR standardizzata. -Pazienti in MR4.5 al momento del pre-screening presso il laboratorio designato da Novartis. -ECOG performance status 0-2. -Adeguata funzionalità degli organi periferici definita da: -Bilirubina diretta ≤ 1.5 x ULN -SGOT (AST) e SGPT (ALT) ≤ 3 x ULN, ovvero equivalente a ≤ Grado 1 secondo NCI-CTCAE v.4.03 -Lipasi sierica ≤ 2 x ULN, ovvero equivalente a ≤ Grado 2 secondo NCI-CTCAE v.4.03 -Fosfatasi alcalina ≤ 2.5 x ULN -Creatinina sierica &lt; 1.5 x ULN -I pazienti devono avere i seguenti valori degli elettroliti entro i limiti di normalità o corretti con integratori per rientrare nei limiti di normalità prima della prima dose di trattamento in studio: -Potassio (mantenimento suggerito per evitare problematiche di anomalie del QT e/o del ritmo cardiaco) -Magnesio (mantenimento suggerito per evitare problematiche di anomalie del QT e/o del ritmo cardiaco) -Calcio totale (corretto per albumina sierica). -I pazienti devono avere una funzionalità midollare normale definita da: -Conta assoluta dei neutrofili (ANC) ≥ 1.5 x 109/L -Emoglobina ≥ 9.0 g/dL -Piastrine ≥ 100 x 109/L Vedere il protocollo per ulteriori criteri
    E.4Principal exclusion criteria
    1) Previous treatment with BCR-ABL inhibitors other than nilotinib for more than a total cumulative duration of 4 weeks 2) Previous treatment with alpha-interferon of any duration 3) Previous anticancer agents for CML other than nilotinib except for cytoreduction after CML diagnosis until up to 4 weeks after first dose of nilotinib 4) Known second chronic phase of CML after previous progression to AP/BC 5) Poorly controlled diabetes mellitus (defined as HbA1c > 9%) 6) Impaired cardiac function as defined in the protocol 7) History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis 8) Known presence of significant congenital or acquired bleeding disorder unrelated to cancer 9) History of another active malignancy within 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively 10) Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks of Day 1 11) Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. 12) Patients actively receiving therapy with herbal medicines that are either discontinued or switched to a different medication prior to starting study drug. These herbal medicines may include Echinacea, (including E. purpurea, E. angustifolia and E. pallida), Piperine, Artemisinin, St. John's Wort, and Ginkgo. 13) Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either safely discontinued or switched to a different medication prior to starting study drug. (Please see http://www.torsades.org/medical-pros/drug-lists/printable-druglist. cfm for a list of agents that prolong the QT interval) 14) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery) 15) Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 16) Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib. Highly effective contraception is defined in the protocol. Additional exclusion criteria are defined in the protocol.
    -Precedente trattamento con inibitori di BCR-ABL diversi da nilotinib per una durata cumulativa totale di oltre 4 settimane. -Precedente trattamento con interferone alfa di qualsiasi durata. -Precedente trattamento con agenti antitumorali per la leucemia mieloide cronica diversi da nilotinib ad eccezione della citoriduzione dopo la diagnosi di leucemia mieloide cronica fino a 4 settimane dopo la prima dose di nilotinib. -Seconda fase cronica di leucemia mieloide cronica nota dopo precedente progressione ad AP/BC. -Diabete mellito scarsamente controllato (definito da HbA1c &gt; 9%). -Deterioramento della funzionalità cardiaca secondo protocollo -Anamnesi di pancreatite acuta nell’anno precedente l’ingresso in studio o anamnesi pregressa di pancreatite cronica. -Nota presenza di disturbi della coagulazione significativi congeniti o acquisiti non correlati al tumore. -Anamnesi di un’altra patologia maligna attiva nei 5 anni precedenti l’ingresso in studio ad eccezione di carcinoma cutaneo basocellulare pregresso e carcinoma in situ pregresso trattato in modo curativo. -Pazienti che non si sono ripresi da intervento chirurgico precedente. -Trattamento con altri agenti sperimentali (definiti come agenti non utilizzati in conformità all’indicazione approvata) nelle 4 settimane precedenti il Giorno 1. -Pazienti che ricevono attivamente terapia con forti inibitori e/o induttori del CYP3A4 e per cui il trattamento non può essere interrotto o passato ad un diverso trattamento prima dell’inizio della terapia con il farmaco in studio. -Pazienti che ricevono attivamente terapia con prodotti erboristici che sono forti inibitori e/o induttori di CYP3A4 e per cui il trattamento non può essere interrotto o passato ad un diverso trattamento prima dell’inizio del farmaco in studio. Tali prodotti erboristici possono comprendere echinacea (comprese E. purpurea, E. angustifolia ed E. pallida), piperina, artemisinina, iperico (erba di San Giovanni) e ginkgo. -Pazienti attualmente in trattamento con qualsiasi farmaco che ha il potenziale di prolungare l’intervallo QT e per cui il trattamento non può essere interrotto o passato ad un altro trattamento in sicurezza prima dell’inizio del farmaco in studio(fare riferimento a http://torsades.org/ medical-pros/drug-lists/printable-drug-list.cfm per un elenco di agenti che prolungano l’intervallo QT). Vedere il protocollo per ulteriori criteri.
    E.5 End points
    E.5.1Primary end point(s)
    BCR-ABL ≤ 0.1% IS (MMR or MR3) at 48 weeks after starting the treatment-free remission (TFR) phase with no loss of MMR and no reinitiation of nilotinib therapy in the first 48 weeks after starting the TFR phase.
    -BCR-ABL ≤ 0.1% IS (MMR o MR3) a 48 settimane dopo aver iniziato la fase di remissione libera dal trattamento (TFR) senza perdita di MMR e senza ripresa della terapia con nilotinib nelle prime 48 settimane dopo aver iniziato la fase di remissione libera dal trattamento (TFR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks after starting the TFR phase
    -48
    E.5.2Secondary end point(s)
    1) BCR-ABL ≤ 0.0032% IS (MR4.5) at 48 weeks after starting the treatment-free remission (TFR) phase with no loss of MR4.5 and no reinitiation of nilotinib therapy in the first 48 weeks after starting the TFR phase. 2) BCR-ABL ≤ 0.1% IS (MMR) at 96, 144 and 192 weeks after starting the TFR phase with no loss of MMR and no re-initiation of nilotinib therapy in the first 96, 144 and 192 weeks after starting the TFR phase 3) BCR-ABL ≤ 0.0032% IS (MR4.5) at 96, 144 and 192 after starting the TFR phase with no loss of MR4.5 and no re-initiation of nilotinib therapy in the first 96, 144 and 192 weeks after starting the TFR phase 4) BCR-ABL < 0.1% at least at one assessment within 12 weeks after restart of nilotinib treatment 5) Duration of re-initiated treatment required to regain MMR is defined as time from date of start of re-initiation of treatment after loss of MMR to the date of first achievement of MMR
    1. BCR-ABL ≤ 0.0032% IS MR4.5) a 48 settimane dopo l’inizio della fase TFR senza perdita di MR4.5 e senza ripresa della terapia con nilotinib nelle prime 48 settimane dopo aver iniziato la fase di TFR. 2. BCR-ABL ≤ 0.1% IS (MMR) a 96, 144 e 192 settimane dopo l'inizio della fase TFR senza perdita di MMR e senza ripresa della terapia con nilotinib nelle prime 96, 144 e 192 settimane dopo aver iniziato la fase di TFR. 3. BCR-ABL ≤ 0.0032% IS (MR4.5) a 96, 144 e 192 settimane dopo l’inizio della fase TFR senza perdita di MR4.5 e senza ripresa della terapia con nilotinib nelle prime 96, 144 e 196 settimane dopo aver iniziato la fase di TFR. 4. BCR-ABL < 0.1% almeno a una valutazione entro 12 settimane dalla ripresa del trattamento con nilotinib. 5. Durata della ripresa del trattamento per ottenere nuovamente la MMR, dopo la perdita di MMR, definita come il tempo dalla data della ripresa del trattamento dopo perdita di MMR alla data del primo riottenimento della MMR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 48 weeks after starting the TFR phase 2 and 3) 96, 144 and 192 weeks after starting the TFR phase 4) within 12 weeks after re-start of nilotinib treatment 5) after re-initation of treatment
    1. 48 settimane dopo aver iniziato la fase di TFR; 2 e 3. 96, 144 e 192 settimane dopo aver iniziato la fase di TFR; 4. entro 12 settimana dopo aver riiniziato il trattamento con nilotinib; 5. dopo aver riiniziato il trattamento
    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 No
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA102
    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
    Argentina
    China
    Colombia
    Japan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 175
    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
    secondo pratica clinica
    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 Decision2013-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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