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    Summary
    EudraCT Number:2009-012576-27
    Sponsor's Protocol Code Number:SORAMIC
    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:2012-03-02
    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 number2009-012576-27
    A.3Full title of the trial
    Evaluation of Sorafenib in combination with local micro-therapy guided by Gd-EOB-DTPA enhanced MRI in patients with inoperable hepatocellular carcinoma
    Valutazione di Sorafenib associato a microterapia locale con guida RMI con Gd-EOB-DTPA in pazienti affetti da carcinoma epatocellulare inoperabile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sorafenib in combination with local micro-therapy in patients with inoperable liver cancer
    Sorafenib associato a microterapia locale in pazienti con epatocarcinoma non operabile
    A.3.2Name or abbreviated title of the trial where available
    SORAMIC
    SORAMIC
    A.4.1Sponsor's protocol code numberSORAMIC
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01126645
    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 SponsorUNIVERSITAT MAGDEBURG, MEDIZINISCHE FAKULTAT
    B.1.3.4CountryGermany
    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 supportSirtex Medical Limited
    B.4.2CountryAustralia
    B.4.1Name of organisation providing supportBayer Schering Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmatrace klinishe
    B.5.2Functional name of contact pointEntwicklung GmbH
    B.5.3 Address:
    B.5.3.1Street AddressAlt-Moabit 60
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10555
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 30 63 22 27 0
    B.5.5Fax number+49 30 63 22 27 99
    B.5.6E-mailsoramic@pharmatrace.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 NEXAVAR
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNSORAFENIB
    D.3.9.1CAS number 284461-73-0
    D.3.9.2Current sponsor codeBAY 43-9006
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB20396
    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.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 Primovist
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNGADOXETIC ACID
    D.3.9.1CAS number 135326-11-3
    D.3.9.2Current sponsor codeBAY-86-4873
    D.3.9.4EV Substance CodeSUB07868MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.025
    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 Yes
    D.3.11.13.1Other medicinal product typeMezzo di contrasto per Risonanza Magnetica
    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 placeboTablet
    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
    Patients with Hepatocellular carcinoma
    Pazienti con epatocarcinoma
    E.1.1.1Medical condition in easily understood language
    Cancer of the liver
    Cancro del fegato
    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 10049010
    E.1.2Term Carcinoma hepatocellular
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019830
    E.1.2Term Hepatocellular carcinoma resectable
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019829
    E.1.2Term Hepatocellular carcinoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    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
    In patients in whom local ablation therapy is appropriate (local ablation group), to determine if the sorafenib in combination with radiofrequency ablation (RFA) prolongs the time-to-recurrence (TTR) in comparison with RFA + placebo. 2. In patients in whom RFA is NOT appropriate (palliative treatment group), to determine if the combination of yttrium-90 microspheres (SIRT) + sorafenib improves the overall survival (OS) in comparison to sorafenib alone. 3. To confirm in a 2-step procedure that Primovist-enhanced MRI is non-inferior (first step) or superior (second step) compared with contrast-enhanced multislice CT for assignment of patients to a palliative vs. local ablation treatment strategy.
    1. In pazienti in cui l'ablazione locale non è adatta, determinare se la combinazione tra sorafenib e radio abalzione (RFA) prolunga il tempo di recidive (TTR) rispetto a RFA e placebo. 2. In pz in cui RFA non è adatto (gruppo palliativo), determinare se la combinazione di microsfere(SIRT) + sorafenib aumenta la sopravvivenza (OS) in confronto al solo sorafenib. 3. confermare che la RM con Primovist sia non-inferiore (Primo step) o superiore (secondo step) alla TAC multistrato con contrasto nell'assegnazione del trattamento palliativo vs. l'ablazione locale
    E.2.2Secondary objectives of the trial
    to assess health-related quality of life to compare the number of detected lesions and the diagnostic confidence in Primovist-enhanced MRI with contrast-enhanced CT to compare Primovist-enhanced MRI with contrast-enhanced CT regarding the detection of recurrence (patients in the local ablation group only) to assess the safety of the combination of RFA + sorafenib in comparison to RFA + placebo to assess the safety of the combination of SIR-Spheres therapy and sorafenib in comparison to sorafenib alone to assess in the palliative study group overall survival separately for patients with and without portal thrombosis
    - valutare la qualità della vita -confrontare il Nr. di lesioni individuate e la confidenza diagnostica della RM con Primovist rispetto la TAC con contrasto - confrontare la RM con Primovist con TAC con contrasto rispetto alle recidive individuate (solo paz nel gruppo ablazione locale) - valutare la sicurezza della combinazione RFA + sorafenib rispetto a RFA + placebo -valutare la sicurezza della combinazione di microsfere SIR e sorafenib rispetto al solo sorafenib -valutare nel gruppo palliativo la sopravvivenza globale separatamente per pazienti con o senza trombosi portale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: 18-85 years 2. Diagnosis of hepatocellular carcinoma 3. If extrahepatic metastases: liver-dominant disease 4. Stage BCLC A, B, or C 5. Child-Pugh A, Child-Pugh B up to 7 points (in patients receiving anticoagulant therapy: Child-Pugh score up to 5 points; INR category not regarded for calculation of the Child-Pugh score) 6. Willing to comply with all study procedures 7. Has voluntarily given written informed consent
    1. paz dai 18 ai 85 anni 2. Diagnosi di epatocarcinoma 3. se metastasi extra epatiche:malattia del fegato dominante 4. Stadio BCLC A, B, o C 5. Child-Pugh A, Child-Pugh B fino a 7 punti 6. volontà di seguire tutte le procedure dello studio 7. consenso informato scritto
    E.4Principal exclusion criteria
    1. If female, pregnant or breast feeding (females of child-bearing potential must use adequate contraception and must have a negative pregnancy test performed within 7 days prior to inclusion into this study) 2. If male, not using adequate birth control measures 3. One or more of the following: - Hemoglobin <10g/dL, - WBC <2,500 cells/mm3, - ANC <1,500 cells/mm3, - platelets <50,000/mm3, - ECOG performance status >2 4. Life expectancy <16 weeks 5. Extrahepatic metastases (except metastases to bone, lymph nodes, and adrenal glands which do not constitute an exclusion criterion) 6. Patients with known GFR <30 mL/min/1.73m2 7. PT-INR/PTT >1.5 times the upper limit of normal (patients on anticoagulation therapy will be allowed to participate provided that no prior evidence exists of an underlying abnormality in anticoagulation) 8. uncontrolled infections at the time of microtherapy 9. Child-Pugh score >7 points; in patients receiving anticoagulant therapy: Child-Pugh score >5 points (INR category not regarded for calculation of the Child-Pugh score) 10. Uncontrolled ascites 11. tumor load of the whole liver >70% 12. Contraindications for study medications according to product labeling or procedures (sorafenib, Primovist, x-ray contrast agents, SIR-Spheres, RFA, MRI, CT) incl. any contraindication to the trans-arterial interventional procedure (e.g., allergy against x-ray contrast agents, uncontrolled hyperthyroidism) 13. Prior resection of the papilla of Vater (e.g., Whipple procedure) or bile duct stent across the papilla 14. Significant cardiovascular disease; e.g., myocardial infarction within 6 months of inclusion, chronic heart failure (New York Heart Association class III or IV), unstable coronary artery disease 15. Uncontrolled hypertension 16. Thrombotic or embolic events including transient ischemic attacks within the past 6 months (tumor-related portal vein thrombosis allowed in the palliative part of the trial). 17. History of GI bleeding within 30 days before inclusion into this study 18. History of esophageal varices bleeding which has not been controlled by effective therapy and/or therapy to prevent bleeding recurrence 19. Previous malignancy other than carcinoma in situ of the skin or the cervix uteri within 5 years prior to inclusion 20. History of organ transplant (including prior liver transplantation) 21. HIV, congenital immune defect, any immunosuppressive therapy for autoimmune disease (rheumatoid arthritis) or inflammatory bowel disease 22. Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial 23. Close affiliation with the investigational site; e.g. first-degree relative of the investigator. 24. Participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 30 days of enrolment into this trial 25. Having been previously enrolled in this clinical trial
    1. se donne, in gravidanza o allattamento al seno (donne in età fertile devono usare contraccetivi adeguati e devono avere un risultato negativo al test di gravidanza eseguito 7 giorni prima dell'inclusione nello studio) 2. se uomini, non utilizzanti adeguati mezzi contraccettivi 3. uno o più dei seguenti valori: - Emoglobina&lt;10g/dL, - WBC &lt;2,500 cells/mm3, - ANC &lt;1,500 cells/mm3, - piastrine &lt;50,000/mm3, - ECOG status&gt;2 4. Aspettativa di vita &lt;16 weeks 5. Metastasi extraepatiche (eccetto metastasi alle ossa, linfonodi e ghiandola surrenale che non cosistuiscono un criterio di esclusione) 6. pazienti con GFR noto &lt;30 mL/min/1.73m2 7. PT-INR/PTT &gt;1.5 limite massimo rispetto al normale 8. infezioni incontrollate al momento della microterapia 9. Child-Pugh score &gt;7 punti 10. ascite incontrollata 11. distribuzione del tumore nell'intero fegato&gt;70% 12. controindicazioni per i farmaci in studio (rispetto al RCP) 13. Precedente intervento chirurgico per resezione della papilla di Vater o posizionamento di uno stent biliare attraverso la papilla 14. Malattia cardiovascolare significativa(infarto miocardico 6 mesi prima dell'inclusione) insufficienza cardiaca cronica(New York Heart Association classe III o IV), e angina instabile 15. ipertensione non controllata 16. Eventi Trombotici o embolie inclusi attacchi ischemici transitori nei passati 6 mesi 17. storia di sanguinamento GI nei 30 giorni prima l'inclusione nello studio 18. episodi di varici esofagee sanguinanti non controllate con terapie efficaci o terapie che prevengono la ricomparsa 19. precedenti tumori maligni oltre al carcinoma in situ della pelle o della cervice uterina nei 5 anni precedenti l'inclusine nello studio 20. storia di trapianto di organi (incluso il precedente trapianto di fegato) 21. HIV, difetto immuno congenito, ogni terapia immunosoppressiva per malattie autoimmunitarie (artrite reumatoide) o malattie infiammatorie dell'intestino 22. condizioni mentali tali da rendere il soggeggo incapace di capire la natura, lo scopo, e le conseguenze dello studio 23. stretti legami con il centro, es: primo grado di parentela con lo sperimentatore 24. partecipante ad un altro studio clinico terapeutico od aver completato la partecipazione di un altro studio terapeutico nei 30 giorni prima dell'inclusione in questo studio 25.Essere stato precedentemente arruolato in questo studio clinico
    E.5 End points
    E.5.1Primary end point(s)
    TTR (LOCAL ABLATION GROUP) Overall survival (palliative treatment group) Number of correct assignments to a local ablation/palliative treatment strategy (diagnostic part of the study)
    -TTR (gruppo di ablazione locale) -sopravvivenza globale (gruppo di trattamento palliativo) -Numero di assegnazioni corrette ablazione locale/trattamento palliativo (parte diagnostica dello studio)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of clinical trial
    Fine dello studio clinico
    E.5.2Secondary end point(s)
    to assses health-related quality of life to compare the nr. of detected lesions and the diagnostic confidence in Primovist-enhanced MRI with contrast-enhanced CT to compare Primovist-enhanced MRI with contrast-enhancee CT regarding the detection of recurrence (pts in the local ablation group only) to assess the safety of the combination of RFA + sorafenib in comparison to RFA + placebo to assess the safety of the combination of SIR-spheres therapy and sorafenib in comparison to sorafenib alone to assess in the palliative study group overall survival separately for patients with and without portal thrombosis
    - valutare la qualità della vita -confrontare il Nr. di lesioni individuate e la confidenza diagnostica della RM con Primovist rispetto la TAC con contrasto - confrontare la RM con Primovist con TAC con contrasto rispetto alle recidive individuate (solo paz nel gruppo ablazione locale) - valutare la sicurezza della combinazione RFA + sorafenib rispetto a RFA + placebo -valutare la sicurezza della combinazione di microsfere SIR e sorafenib rispetto al solo sorafenib -valutare nel gruppo palliativo la sopravvivenza globale separatamente per pazienti con o senza trombosi portale
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of clinical trial
    Fine dello studio clinico
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    gruppo ablazione (sorafenib o placebo) gruppo palliativo (sorafenib o dipositivo medico+sorafenib)
    RFA group (sorafenib or placebo) palliative group (sorafenib or medical device+sorafenib)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    TAC con contrasto
    Contrast enhanced CT
    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 concerned6
    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
    Croatia
    Switzerland
    Turkey
    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 months35
    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 months58
    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: 222
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 443
    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 state132
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 533
    F.4.2.2In the whole clinical trial 665
    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)
    Post-study therapy will follow routine clinical care
    I pazienti dopo aver concluso lo studio clinico seguiranno il trattamento clinico routinario per il loro tipo di patologia
    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 Decision2012-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-31
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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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