Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004166-33
    Sponsor's Protocol Code Number:RV-MM-PI-0752
    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:2013-12-05
    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 number2013-004166-33
    A.3Full title of the trial
    A PHASE III, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD SCHEDULE VERSUS A NEW ALGORITHM OF DOSE REDUCTIONS IN ELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING LENALIDOMIDE PLUS STEROIDS
    STUDIO DI FASE III, MULTICENTRICO, RANDOMIZZATO, CONTROLLATO FINALIZZATO A DETERMINARE L’EFFICACIA E LA SICUREZZA DEL TRATTAMENTO STANDARD CON LENALIDOMIDE E DESAMETASONE VERSUS UN NUOVO ALGORITMO CHE PREVEDE RIDUZIONE DI DOSE IN PAZIENTI ANZIANI CON NUOVA DIAGNOSI DI MIELOMA MULTIPLO E INADATTI A RICEVERE CHEMIOTERAPIA CONVENZIONALE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL STUDY FINALIZED TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD TREATMENT WITH THE LENALIDOMIDE E DEXAMETHASONE DRUGS COMPARED WITH THE DOSE REDUCTIONS IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA THAT CAN NOT RECEIVE THE STANDARD CHEMIOTHERAPY
    STUDIO CLINICO FINALIZZATO A DETERMINARE L’EFFICACIA E LA SICUREZZA DEL TRATTAMENTO STANDARD CON I FARMACI LENALIDOMIDE E DESAMETASONE CONFRONTO ALLA RIDUZIONE DI DOSE IN PAZIENTI ANZIANI AFFETTI DA NUOVA DIAGNOSI DI MIELOMA MULTIPLO CHE NON POSSONO RICEVERE CHEMIOTERAPIA STANDARD
    A.3.2Name or abbreviated title of the trial where available
    Rd vs Rd-R
    Rd vs Rd-R
    A.4.1Sponsor's protocol code numberRV-MM-PI-0752
    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 SponsorFO.NE.SA.Onlus
    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 supportCelgene
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFO.NE.SA.Onlus
    B.5.2Functional name of contact pointUFFICIO SPERIMENTAZIONI CLINICHE
    B.5.3 Address:
    B.5.3.1Street AddressVia Genova 3
    B.5.3.2Town/ cityTorino
    B.5.3.3Post code10126
    B.5.3.4CountryItaly
    B.5.4Telephone number+390116336107
    B.5.5Fax number+390116963737
    B.5.6E-mailgismm2001@yahoo.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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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/3/03/177
    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.3.11 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 typeAntineoplastic medicine
    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 SOLDESAM
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIO FARMACOLOGICO MILANESE s.r.l.
    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 Oral drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 typeCytostatic treatment
    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
    ELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS
    PAZIENTI ANZIANI AFFETTI DA MIELOMA MULTIPLO DI NUOVA DIAGNOSI
    E.1.1.1Medical condition in easily understood language
    ELDERLY PATIENTS WITH NEWLY DIAGNOSED
    PAZIENTI ANZIANI A CUI E’ STATO DIAGNOSTICATO IL 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 18.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy and the safety of the standard Rd schedule (arm A) versus an experimental approach including the standard Rd regimen as induction, followed by lenalidomide alone as maintenance (arm B).
    Comparare l’efficacia e la sicurezza del trattamento standard con Rd (Braccio A) con un approccio sperimentale con Rd in regime di induzione, seguito da solo lenalidomide in mantenimento (Braccio B).
    E.2.2Secondary objectives of the trial
    To compare additional efficacy outcome as overall survival, overall responses and quality of life.
    Valutare ulteriori risultati di efficacia come sopravvivenza generale, risposta generale e qualità di vita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients >65 years unfit and unsuitable, according to the investigator’s opinion, to receive approved first line treatments for newly diagnosed MM.
    - Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
    - Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
    - Symptomatic MM based on standard CRAB criteria (5).
    - Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results.
    - All randomized patients will be selected based on the use of 3 geriatric scales: IADL, ADL, Charlson. Unfit patients with clinical sign of frailty (mild, moderate or severe frailty), including need help for household tasks and personal care can be enrolled in this trial (2,4).
    - In order to include patients who normally are not select for clinical trials, also patients with the following abnormal laboratory values can be considered:
    a) absolute neutrophil count (ANC) < 1 x 10^9/L
    b) platelet count < 80 x 10^9/L
    c) haemoglobin < 8 g/dl.
    d) aspartate transaminase (AST): < 5 x the upper limit of normal (ULN).
    e) alanine transaminase (ALT): < 5 x the ULN.
    f) total bilirubin: > 1.5 x the ULN
    g) calculated or measured creatinine clearance: <30 mL/minute

    The geriatric assessment evaluations will select unfit patients to be randomized regardless of possible abnormal laboratory values at the study entry.
    - Paziente con età superiore ai 65 anni inadatto e non idoneo, secondo l’opinione dello Sperimentatore, a ricevere un trattamento di prima linea approvato per la nuova diagnosi di MM.
    - Paziente che, secondo l’opinione dello Sperimentatore Principale, ha la volontà e la capacità di rispettare i requisiti del protocollo.
    - Paziente che abbia dato il suo consenso informato volontario e scritto prima di sottoporsi a qualsiasi terapia o procedura inerente allo studio, che non rientri nella normale pratica medica, con la consapevolezza che il consenso può essere ritirato dal paziente stesso in ogni momento senza pregiudicare il trattamento futuro.
    - MM sintomatico basato sui criteri dei CRAB standard(5).
    - Paziente con malattia misurabile, definita come segue: qualsiasi valore quantificabile della proteina monoclonale sierica (generalmente, ma non necessariamente ≥ 0.5 g/dL di proteina M) e, dove applicabile, catene leggere urinarie >200 mg/24 ore. Per pazienti con MM oligo o non secernente, è richiesto che abbiano un plasmocitoma misurabile > 2 cm determinato da esami clinici o radiografie del caso (per esempio MRI, CT-Scan) o un anomalo rapporto delle catene leggere libere (n.v.: 0.26-1.65). Al fine di massimizzare l’interpretazione dei risultati di efficacia prevediamo che meno del 10% dei pazienti ammessi allo studio saranno affetti da MM oligo o non secernente con catene leggere libere.
    - Tutti i pazienti randomizzati dovranno essere selezionati in base all’uso di 3 scale geriatriche: IADL, ADL, Charlson. I pazienti inadatti con segni clinici di fragilità (lieve, moderata o grave fragilità), compreso il bisogno di aiuto per i compiti domestici e di cura della persona, possono essere arruolati in questo studio clinico (2,4).
    - Al fine di includere i pazienti che normalmente non sono arruolabili in sperimentazioni cliniche, anche i pazienti con i seguenti valori di laboratorio anormali possono essere valutati:
    a) conta assoluta dei neutrofili (ANC) < 1 x 10^9/L
    b) conta piastrinica < 80 x 10^9/L
    c) emoglobina < 8 g/dl.
    d) aspartato transaminasi (AST): < 5 x il limite superiore alla norma (ULN).
    e) alanina transaminasi (AST): < 5 x il ULN.
    f) bilirubina totale: > 1.5 x il ULN
    g) clearance della creatinina calcolata o misurata: <30 mL/min

    Le valutazioni geriatriche determineranno i pazienti inadatti al fine di essere randomizzati indipendentemente da possibili valori di laboratorio anormali all’ingresso nello studio.
    E.4Principal exclusion criteria
    - Pregnant or lactating females.
    - Male patients not agreeing to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
    - Females of childbearing potential not agreeing to use two acceptable methods for contraception (e.g. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
    - Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid < to the equivalent of dexamethasone 40 mg/day for 4 days).
    - Any significant medical disease or conditions that, in the investigator’s opinion, may interfere with protocol adherence or subject’s ability to give informed consent or could place the subject at unacceptable risk.
    - Presence of clinical active infectious hepatitis type B or C, classified into Child-Pugh class C (see Appendix V).
    - Presence of acute active infection requiring antibiotics or infiltrative pulmonary disease.
    - Contraindication to any of the required drugs or supportive treatments.
    - Presence of prior history of malignancies, other than multiple myeloma, with a life expectancy < 2 years.
    - Known allergy to any of the study medications, their analogues, or excipients in the various formulations.
    - Donne incinte o in allattamento.
    - Pazienti di sesso maschile che non accetti di utilizzare un efficace metodo contraccettivo per l’intera durata dello studio (per esempio profilattico o astinenza).
    - Pazienti di sesso femminile in età fertile che non accetti di utilizzare due metodi contraccettivi per l’intera durata dello studio (per esempio: contraccettivo ormonale, dispositivo intrauterino, diaframma con spermicida, preservativo con spermicida o astinenza).
    - Trattamenti precedenti con terapie anti-mieloma (non sono inclusi la radioterapia, I bifosfonati, o un unico ciclo breve di steroidi inferiore all’equivalente del desametasone 40 mg/giorno per 4 giorni).
    - Qualsiasi altra malattia o condizione medica clinicamente significativa che, a giudizio dello Sperimentatore, possa interferire con l'aderenza al protocollo o con la capacità del soggetto di prestare il consenso informato o che possa sottoporre il soggetto ad un rischio inaccettabile.
    - Presenza di epatite attiva di tipo B o C, classificate nel Child-Pugh classe C (vedere Appendice V del protocollo).
    - Presenza di infezioni attive acute che richiedono antibiotici o pneumopatia infiltrativa.
    - Controindicazione a qualsiasi farmaco concomitante richiesto o ai trattamenti di supporto.
    - Presenza di precedente storia di neoplasie, oltre al mieloma multiplo, con un’aspettativa di vita < a 2 anni.
    - Allergie conosciute a qualsiasi farmaco in studio e loro analoghi, o eccipienti delle varie formulazioni.
    E.5 End points
    E.5.1Primary end point(s)
    Event-free survival defined as:
    • Progression
    • Death for any cause
    • Discontinuation of lenalidomide therapy
    • Occurrence of any haematological grade 4 or non-haematological grade 3-4 adverse events (AES), including Secondary Primary Malignancies (SPMs)
    Sopravvivenza libera da eventi definita come:
    • Progressione
    • Morte per qualsiasi causa
    • Interruzione del trattamento con lenalidomide
    • Presenza di qualsiasi evento avverso ematologico di grado 4 o non-ematologico di grado 3-4, inclusi i tumori secondari primari (SPMs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 anni
    E.5.2Secondary end point(s)
    • Progression-free survival (PFS)
    • Overall survival (OS)
    • Time to progression (TTP)
    • Overall response rate (ORR)
    • Time to response (TTR)
    • Duration of response (DOR)
    • Time to the next therapy (TNT)
    • Incidence of dose reduction and drug discontinuation
    • Health care cost and quality of life assessment (HRQOL)
    • Modification of response and outcome in subgroups with different prognosis according to current prognostic factors
    • Sopravvivenza libera da progressione (PFS)
    • Sopravvivenza globale (OS)
    • Tempo di progressione (TTP)
    • Tasso di risposta globale (ORR)
    • Tempo di risposta (TTR)
    • Durata della risposta (DOR)
    • Tempo per la successive terapia (TNT)
    • Incidenza della riduzione di dose e interruzione del farmaco
    • Costi di assistenza sanitaria e valutazione della qualità della vita (HRQOL)
    • Modifica della risposta e del risultato in sottogruppi con diversa prognosi in base agli attuali fattori prognostici
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 years
    5 anni
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Stessi medicinali con differente schedula di trattamento
    Same drugs with different treatment schedules
    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 concerned37
    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 years5
    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 years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state200
    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)
    At the end of the study the patient will continue to be followed by your doctor.
    Al termine dello studio il paziente continuerà ad essere seguito dal proprio medico.
    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 Decision2014-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 06 19:35:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA