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    Summary
    EudraCT Number:2012-002602-52
    Sponsor's Protocol Code Number:BAY80-6946/16349
    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:2012-10-19
    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 number2012-002602-52
    A.3Full title of the trial
    Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas
    Studio di fase II in aperto, non controllato, con un inibitore endovenoso di PI3K, BAY 80-6946,in pazienti affetti da linfoma Non-Hodgkin recidivato, indolente o aggressivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II PI3K inhibitor in relapsed, indolent or aggressive NHL
    Studio di Fase II con inibitore di PI3K nel linfoma Non-Hodgkin (LNH) recidivato, indolente o aggressivo
    A.4.1Sponsor's protocol code numberBAY80-6946/16349
    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 SponsorBAYER HEALTHCARE AG
    B.1.3.4CountryGermany
    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 supportBAYER HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBAYER HealthCare AG
    B.5.2Functional name of contact pointCTP Team/Ref:"EU CTR"/S102 - R156
    B.5.3 Address:
    B.5.3.1Street AddressBerlin
    B.5.3.2Town/ cityBERLIN
    B.5.3.3Post code13343
    B.5.3.4CountryItaly
    B.5.4Telephone numberNA
    B.5.5Fax numberNA
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCopanlisib
    D.3.2Product code BAY 80-6946
    D.3.4Pharmaceutical form Powder for solution for infusion
    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 INNCopanlisib
    D.3.9.2Current sponsor codeBAY 84-1236
    D.3.9.4EV Substance CodeSUB32033
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number92.16
    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
    Patients with relapsed, indolent or aggressive Non Hodgkin’s lymphomas
    Linfoma Non-Hodgkin (LNH) recidivato, indolente o aggressivo.
    E.1.1.1Medical condition in easily understood language
    patients with relapsed, indolent or aggressive Non Hodgkin’s lymphomas
    Linfoma Non-Hodgkin recidivato, indolente o aggressivo.
    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 HLT
    E.1.2Classification code 10029608
    E.1.2Term Non-Hodgkin's lymphomas unspecified histology aggressive
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10065856
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent
    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
    The objective of this study is to evaluate the efficacy and safety of BAY 80 6946 in patients with indolent or aggressive Non-Hodgkin’s Lymphoma (NHL) who have progressed after standard therapy.
    Lo scopo di questo studio è valutare l’efficacia e la sicurezza di BAY 80-6946 in pazienti affetti da LNH indolente o aggressivo, in progressione dopo terapia standard.
    E.2.2Secondary objectives of the trial
    Further objectives are to evaluate the pharmacokinetics of BAY 80-6946 and biomarkers.
    Obiettivi secondari sono la valutazione della farmacocinetica di BAY 80-6946 e di marcatori biologici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Indolent NHL: • Histologically confirmed diagnosis of follicular lymphoma (FL), marginal zone lymphoma (including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue [MALT] lymphoma), lymphoplasmacytic lymphoma/Waldenström macroglobulinemia, chronic lymphocytic leukemia (CLL). • Relapsed after ≥ 2 prior chemotherapy- or immunotherapy-based regimens for indolent NHL, or refractory to 2 prior chemotherapy- and/or immunotherapy-based regimens. Aggressive NHL: • Histologically confirmed diagnosis of Grade 3 follicular lymphoma (FL), transformed indolent lymphoma, diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma(DLBCL), mantle cell lymphoma (MCL), peripheral T-cell lymphoma, or anaplastic large cell lymphoma. • Relapsed after ≥ 2 prior chemotherapy regimens, including the following: first-line treatment with standard anthracycline-containing regimen (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At least 1 additional combination chemotherapy regimen. Patients refractory to first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL or not eligible for high-dose regimen followed by transplant. High-dose chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is considered 1 regimen. Patients with CD20 expressing neoplastic cells must have received prior rituximab, if available. Applicable to all patients: • Ability to understand and willingness to sign written informed consent (IC). Signed informed consent must be obtained before any study specific procedure. • Male or female patients > 18 years of age. • Patients with NHL must have at least one measurable lesion according to the recommendations of the Report of an International Workshop to Standardize Response Criteria for NHL. • ECOG performance status ≤ 2. • Life expectancy of at least 3 months. • Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last test drug administration. The investigator or a designated associate is requested to advise the patient how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care. An adequate contraception includes a hormonal contraception with implants or combined oral, transdermal or injectable contraceptives, certain intrauterine devices, bilateral tubal ligation, hysterectomy, or vasectomy of the partner. In addition the use of condoms for patients or their partners is required unless the woman has had a hysterectomy. • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment: - Total bilirubin < 1.5 x the upper limit of normal (ULN) (< 3 x ULN for patients with Gilbert-Meulengracht syndrome). - ALT and AST < 2.5 x ULN (< 5 x ULN for patients with lymphomatous liver involvement of their cancer). - Amylase and lipase < 1.5 x the ULN - Serum creatinine < 1.5 x the ULN. - GFR ≥ 30 ml/min/1.73 m2 according to the MDRD abbreviated formula. - INR or PTT < 1.5 x ULN. Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care. - Platelet count ≥ 75,000 /mm3, hemoglobin (Hb) ≥ 9 g/dL, ANC ≥ 1,500/mm3 - Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer). • LVEF ≥ LLN for the Institution
    Diagnosi confermata istologicamente di linfoma follicolare (LF), linfoma della zona marginale (incluso il linfoma a cellule B della zona marginale nodale o splenico ed il linfoma del tessuto linfoide associato alle mucose [MALT]), linfoma linfoplasmocitico /macroglobulinernia di Waldenström, leucemia linfatica cronica (CLL). • Pazienti recidivati dopo almeno 2 precedenti regimi di chemioterapia od immunoterapia per LNH indolente, o refrattari a 2 precedenti regimi di chemioterapia o immunoterapia. Diagnosi confermata istologicamente di linfoma follicolare (LF) di grado 3, linfoma indolente trasformato, linfoma diffuso a grandi cellule B (DLBCL), linfoma a grandi cellule B mediastinico, linfoma mantellare (MCL), linfoma a cellule T periferiche o linfoma anaplastico a grandi cellule.-Pazienti recidivati dopo almeno 2 precedenti regimi chemioterapici comprendenti un trattamento di prima linea con un regime standard contenente antracicline (ad es. ciclofosfamide, doxorubicina, vincristina e prednisone od uno equivalente).Almeno un ulteriore regime chemioterapico combinato. Pazienti refrattari al primo regime di chemioterapia e/o immunoterapia per LNH aggressivi o che non siano elegibili per un regime ad alte dosi seguito da trapianto. La chemioterapia ad alte dosi o la chemioradioterapia seguita da trapianto autologo di cellule staminali sono considerate 1 regime. Pazienti le cui cellule neoplastiche esprimano il CD20 devono aver precedentemente ricevuto il rituximab, se disponibile.-Pazienti maschi o femmine di età &gt; 18 anni • ECOG Performance status ≤ 2 (ECOG: Eastern Cooperative Oncology Group) • Aspettativa di vita di almeno 3 mesi • Adeguata funzione midollare, epatica e renale valutata entro i 7 giorni precedenti all’inizio del trattamento • Frazione di eiezione ventricolare sinistra (LVEF) ≥ al limite inferiore del normale intervallo di riferimento (LLN) del centro
    E.4Principal exclusion criteria
    • Previous or concurrent cancer that is distinct in primary site or histology from cancer of the lymphatic system within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]. • Symptomatic lymphomatous involvement of the brain. • Congestive heart failure > NYHA class 2. • Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of test drug. • Uncontrolled hypertension. (Blood pressure ≥ 150/90 mmHg despite optimal medical management). • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication. • Non-healing wound, ulcer, or bone fracture. • Active clinically serious infections (> CTCAE grade 2). • Known history of human immunodeficiency virus (HIV) infection. • Known history of chronic hepatitis B or C. • Patients with seizure disorder requiring medication. • Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks of start of study medication. • Renal failure requiring hemo-or peritoneal dialysis. • Dehydration of CTCAE grade ≥ 1 (NCI-CTC version 4.0). • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results. • Known hypersensitivity to any of the test drugs, test drug classes, or excipients in the formulation. • History or concurrent condition of interstitial lung disease. • Persistent proteinuria of CTCAE grade 3 or higher (> 3.5 g/24 h, measured by urine protein: creatinine ratio on a random urine sample). • Unresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any prior therapy/procedure excluding alopecia. • Current diagnosis of Type 1 or 2 diabetes mellitus, fasting blood glucose > 125 mg/dL (> 6.9 mmol/L) or HbA1c ≥ 7.0 % • Patients with phaeochromocytoma. • Pregnant or breast-feeding patients. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment. • Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g. employee or student of the investigational site). • Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study (see also Section 6.9 and Appendix 14.2). • Previous assignment to treatment during this study. Patients permanently withdrawn from study participation will not be allowed to re-enter the study. Excluded previous therapies and medications: • Prior treatment with PI3K inhibitors. • Treatment with investigational drugs other than PI3K inhibitors within the last 28 days. • Ongoing immunosuppressive therapy. • Radiotherapy within 4 weeks prior to treatment start. • Systemic corticosteroid therapy (ongoing). Patients may be using topical or inhaled corticosteroids. • History of having received an allogeneic bone marrow or organ transplant • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication. • Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). • Use of strong inhibitors of CYP3A4 is prohibited from Day -14 and for the duration of the study • Use of strong inducers of CYP3A4 is prohibited from Day -14 of Cycle 1 and for the duration of the study.
    • Ipertensione non controllata (pressione arteriosa ≥ 150/90 mmHg nonostante una terapia medica ottimale) • Diagnosi attuale di diabete mellito di tipo 1 o 2, glicemia a digiuno &gt; 125 mg/dL (&gt; 6,9 mmol/L) o HbAlc ≥ 7,0 % (HbA1c = emoglobina glicata) • Pazienti con evidenza o anamnesi postiva per diatesi emorragica. Qualunque emorragiao sanguinamento di grado CTCAE ≥ 3 nelle 4 settimane precedenti la prima assunzione del farmaco sperimentale (CTCAE: Common Terminology Criteria for Adverse Events) • Storia o presenza concomitante di pneumopatia interstiziale • Qualunque tossicità non risolta di grado CTCAE superiore a 1 (NCI-CTC versione 4.0) attribuita a qualsiasi precedente terapia/procedura ad esclusione dell’alopecia. (NCI: National Cancer Institute) • Precedente trattamento con inibitori di PI3K • Terapia sistemica con corticosteroidi (in corso)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the objective tumor response (OR). OR will be assessed in all patients up to 16 weeks after the last patient fully evaluable for the primary endpoint will have started treatment.
    La variabile primaria di efficacia sarà la risposta globale oggettiva del tumore. La risposta globale verrà valutata in tutti i pazienti 16 settimane dopo che l’ultimo paziente pienamente valutabile per l’obiettivo primario abbia cominciato il trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of the primary efficacy variable will be performed 16 weeks after the last patient fully evaluable for the primary endpoint will have started treatment. At that timepoint, an exploratory analysis of all other variables will be performed, if possible
    La primaanalisi della variabile primaria di efficacia verrà eseguita 16 settimane dopo che l’ultimo paziente pienamente valutabile per l’obiettivo primario avrà iniziato il trattamento. In questo momento, se possibile, verrà eseguita un’analisi esplorativa di tutte le altre variabili.
    E.5.2Secondary end point(s)
    Secondary efficacy variables in this study will be: • Duration of response (DOR), defined as the time (in days) from first observed tumor response (CR, CRu [applicable only in patients with NHL] or PR) until PD or until death caused by PD. • Progression free survival (PFS), defined as the time (in days) from treatment assignment to disease progression or death (if death occurs before a documented progression). • Overall survival (OS), defined as the time (in days) from treatment assignment until death from any cause or until the last date the patient is known to be alive
    Le variabili secondarie di efficacia sono: • Durata della risposta (DOR), definita come i giorni dalla prima risposta al tumore osservata (CR, CRu [solo per Pazienti con NHL] o PR) fino a progressione di malattia o morte. • Sopravvivenza libera da progressione (PFS), definita come il tempo(in giorni) dall'assegnazione del trattamento alla progressione di malattia o morte (se la morte avviene prima di una progressione documentata). Sopravvivenza globale (OS), definita come tempo (in giorni) dall'assegnazione del trattamento fino a morte per qualsiasi causa fino all'uiltimo giorno di vita del Paziente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final analyses of all secondary efficacy and safety variables and an additional exploratory analysis of the primary efficacy variable will be performed 3 years after the last patient’s first treatment or when all patients got PD, whatever comes first
    L’analisi finale di tutte le variabili secondarie di efficacia e di sicurezza ed un’ulteriore analisi esplorativa della variabile primaria di efficacia verranno eseguite 3 anni dopo il primo trattamentodell’ultimo pazientearruolato o quando tutti i pazienti saranno andati incontro a progressione di malattia, quale delle due condizioni si osservi per prima.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tumor response
    Risposta tumore
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Canada
    United States
    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
    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 months42
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months42
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 60
    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
    nessuno
    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 Decision2013-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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