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    Summary
    EudraCT Number:2011-004893-28
    Sponsor's Protocol Code Number:CLAMYIIFF
    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:2012-03-08
    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 number2011-004893-28
    A.3Full title of the trial
    PHASE II STUDY OF CLOFARABINE IN COMBINATION WITH CYTARABINE AND LIPOSOMAL DOXORUBICIN IN CHILDREN WITH EITHER LYMPHOBLASTIC OR MYELOID RELAPSE OR REFRACTORY ACUTE LEUKEMIA AND IN CHILDREN WITH SECONDARY ACUTE MYELOID LEUKEMIA
    STUDIO DI FASE II SULL'UTILIZZO DI CLOFARABINA IN COMBINAZIONE CON CITARABINA E DOXORUBICINA LIPOSOMIALE IN PAZIENTI PEDIATRICI CON DIAGNOSI DI LEUCEMIA LINFOBLASTICA ACUTA E LEUCEMIA MIELOIDE ACUTA IN RECIDIVA O REFRATTARIA O DI LEUCEMIA MIELOIDE ACUTA SECONDARIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY AND TOLERABILITY EVALUATION OF CLOFARABINE, CYTARABINE AND LIPOSOMAL DOXORUBICIN IN CHILDREN WITH EITHER LYMPHOBLASTIC OR MYELOID RELAPSED OR REFRACTORY ACUTE LEUKEMIA AND IN CHILDREN WITH SECONDARY ACUTE MYELOID LEUKEMIA
    VALUTAZIONE DELL’EFFICACIA E DELLA TOLLERABILITA' DEL FARMACO CLOFARABINA USATO IN ASSOCIAZIONE A CITARABINA E DOXORUBICINA LIPOSOMIALE NEL TRATTAMENTO DEI BAMBINI CON DIAGNOSI DI LEUCEMIA ACUTA LINFOBLASTICA O MIELOIDE IN RICADUTA O RESISTENTE ALLE PRECEDENTI TERAPIE O DI LEUCEMIA MIELOIDE ACUTA SECONDARIA A PRECEDENTI TRATTAMENTI CHEMIOTERAPICI
    A.3.2Name or abbreviated title of the trial where available
    CLA-MYOCET
    CLA-MYOCET
    A.4.1Sponsor's protocol code numberCLAMYIIFF
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA
    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 supportAZIENDA OSPEDALIERA O.I.R.M.-S.ANNA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERA O.I.R.M.-S.ANNA
    B.5.2Functional name of contact pointS.C. ONCOEMATOLOGIA E CENTRO TRAP.
    B.5.3 Address:
    B.5.3.1Street AddressPIAZZA POLONIA 94
    B.5.3.2Town/ cityTORINO
    B.5.3.3Post code10126
    B.5.3.4CountryItaly
    B.5.4Telephone number0113135997
    B.5.5Fax number0113135487
    B.5.6E-mailfranca.fagioli@unito.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name EVOLTRA*4FL 20ML 1MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderGENZYME Srl
    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/3/01/0823
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate 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 INNCLOFARABINE
    D.3.9.1CAS number 123318-82-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB21902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAGENTE ANTINEOPLASTICO
    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
    RELAPSED/REFRACTORY PEDIATRIC ACUTE EITHER LYMPHOBLASTIC OR MYELOID LEUKEMIA AND SECONDARY ACUTE MYELOID LEUKEMIA.
    LEUCEMIA LINFOBLASTICA ACUTA E LEUCEMIA MIELOIDE ACUTA IN RECIDIVA O REFRATTARIA O LEUCEMIA MIELOIDE ACUTA SECONDARIA
    E.1.1.1Medical condition in easily understood language
    ACUTE LEUKEMIAS NOT RESPONDING TO CHEMOTHERAPY OR COMING BACK AFTER PRIOR CHEMOTHERAPY AND ACUTE MYELOID LEUKEMIA ARISEN AFTER CHEMOTHERAPY
    LEUCEMIE ACUTE CHE SI RIPRESENTANO DOPO AVER RISPOSTO ALLA/E TERAPIA/E INIZIALE/I O CHE NON RISPONDONO AI TRATTAMENTI IN ATTO O SECONDARIE A PREGRESSI TRATTAMENTI CHEMIOTERAPICI
    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 10060356
    E.1.2Term Acute myeloid leukaemia without mention of remission
    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 PT
    E.1.2Classification code 10059034
    E.1.2Term Acute myeloid leukaemia 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 10060352
    E.1.2Term Acute lymphoid leukaemia without mention of remission
    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 10063621
    E.1.2Term Acute lymphoblastic leukaemia recurrent
    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
    EVALUATION OF EFFICACY OF CLOFARABINE IN COMBINATION WITH CYTARABINE AND LIPOSOMAL DOXORUBICIN IN CHILDREN WITH RELAPSED/REFRACTORY ACUTE EITHER LYMPHOBLASTIC OR MYELOID ACUTE LEUKEMIA AND SECONDARY ACUTE MYELOID LEUKEMIA
    DETERMINARE L'EFFICACIA DI CLOFARABINA IN ASSOCIAZIONE A CITARABINA (ARA-C) E DOXORUBICINA LIPOSOMIALE (MYOCET) (MY) IN PAZIENTI PEDIATRICI CON DIAGNOSI DI LEUCEMIA LINFOBLASTICA ACUTA IN SECONDA O SUCCESSIVA RICADUTA O RESISTENTE E LEUCEMIA MIELOIDE ACUTA IN RECIDIVA O REFRATTARIA O SECONDARIA
    E.2.2Secondary objectives of the trial
    safety and tolerability of clofarabine in combination with cytarabine and liposomal doxorubicin in children with relapsed/refractory acute either lynphoblastic or myeloid acute leukemia and secondary acute myeloid leukemia
    Sicurezza e tollerabilità della combinazione terapeutica in studio
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    CARDIAC EVALUATION DURING TREATMENT AND FOLLOW UP Version 1 03/10/2011 Objective: Cardiac evaluation
    ALTRI SOTTOSTUDI:
    VALUTAZIONE DELLA FUNZIONALITÀ CARDIACA IN CORSO DI TRATTAMENTO E DURANTE IL FOLLOW-UP VERSIONE 1 del 03/10/2011 Obiettivo: valutazione della funzionalità cardiaca
    E.3Principal inclusion criteria
    - Age at diagnosis between 1 and 21 years (20 years and 364 days) - Second or subsequent isolated bone marrow relapses of ALL - Refractory ALL - First or subsequent isolated bone marrow relapses of AML - Either refractory or secondary AML in patients who received previous chemotherapy - Lansky or Karnofsky Performance Status score > 60% - Life expectancy > 6 weeks - Normal Heart function (VEF ≥ 55% 2-D echocardiography) and history negative for concomitant medication to treat cardiopathy -Good organ function defined by: 1) serum creatinine <2 times the upper limit for age, 2) total bilirubin <1.5 times the upper limit of age, 3) transaminases ≤ 2.5 times the upper limit for age, 4) alkaline phosphatase ≤ 2.5 times the upper limit for age -For female patients with childbearing potential, a negative test for pregnancy is to be considered before entry on study -Male and female patients must use an effective contraceptive method during the study and for a minimum of 3 months after study treatment; -Written signed informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations
    - Età alla diagnosi compresa tra 1 e 21 anni (20 anni e 364 giorni) -Pazienti con diagnosi di LLA in seconda o successiva recidiva midollare isolata o refrattaria al trattamento -Pazienti con diagnosi di LMA in prima o successiva ricaduta midollare isolata o refrattaria al trattamento -Pazienti con diagnosi di LMA secondaria e che abbiano ricevuto un pregresso trattamento chemioterapico -Lansky score o Karnofsky Performance status &gt; 60% -Aspettativa di vita stimata &gt;6 settimane -Funzionalità cardiaca normale (FEV≥55% all’ecocardiogramma 2-D) e negatività per trattamento farmacologico in atto per cardiopatia -Buona funzionalità d’organo sia epatica che renale definita dai seguenti parametri: 1) creatinina serica &lt; 2 volte il limite superiore per età; 2) bilirubina totale &lt; 1,5 volte il limite superiore per età; 3) transaminasi ≤ 2.5 volte il limite superiore per età; 4) fosfatasi alcalina ≤ 2.5 volte il limite superiore per età -I soggetti di sesso femminile che abbiano già avuto menarca devono presentare un test di gravidanza negativo prima dell’inizio dello studio -Per i pazienti di entrambi i sessi che siano in grado di concepire figli è necessaria l’assunzione di un contraccettivo (per pazienti di sesso femminile contraccettivo orale) per tutta la durata del trattamento e fino a 3 mesi dopo la fine dello stesso -Firma del consenso informato da parte dei genitori/tutore e/o del paziente
    E.4Principal exclusion criteria
    -Isolated extramedullary relapse of ALL and AML -First isolated bone marrow relapse of ALL -Patients with involvement of central nervous system (CNS) at diagnosis of refractory / relapse of ALL and AML or of secondary AML -Early (<3 months) bone marrow relapse after HSCT (hematopoietic Stem Cell Transplantation) -acute promyelocytic leukemia -Acute leukemia in first or subsequent isolated bone marrow relapse or refractory in patients with Down Syndrome - Current or recent (<30 days) history of either fungal or bacterial infections requiring treatment at diagnosis of either relapsed/refractory ALL/AML or secondary AML -Chemotherapy treatment in the 2 weeks before study entry. Granulocyte growth factor, leukapheresis and cranial irradiation should be discontinued at least 48 hours before the beginning of the protocol - Severe organ dysfunction, especially liver, kidneys, heart and lungs -Other concurrent severe disease that makes it inappropriate to enroll the patient in the study - History of a previous veno-occlusive disease (VOD) -Expected non-compliance to protocol schedule or unable to have regular follow-up due to psychological, social, familial reasons -Hypersensitivity to cytarabine, clofarabine, liposomal daunorubicin -Concomitant administration of any other experimental drug under investigation, or concurrent treatment with any other anti-cancer therapy other than specified in the protocol is not allowed -Pregnant or lactating patients
    -Recidiva extramidollare isolata di LLA e LMA -Prima recidiva midollare isolata di LLA -Pazienti con coinvolgimento del Sistema Nervoso Centrale (SNC) alla diagnosi di refrattarietà/recidiva di LLA e LMA o di LMA secondaria -Recidiva midollare precoce (&lt;3 mesi) post-trapianto Pazienti con diagnosi di Leucemia Acuta Promielocitica -Pazienti con diagnosi di Leucemia Acuta in prima o successiva ricaduta midollare isolata o refrattaria al trattamento o con diagnosi di LMA secondaria, affetti da Sindrome di Down -Sepsi grave in atto o storia recente (&lt; 30 giorni) di infezioni fungina o batterica documentata che richiedano trattamento con antifungini o antibiotici al momento della diagnosi di LLA o LMA recidivata/refrattaria o LMA secondaria -Trattamento chemioterapico nelle 2 settimane precedenti l’entrata nello studio. L’utilizzo di fattore di crescita granulocitario, radioterapia cranica e leucaferesi deve essere interrotto almeno 48 ore prima -Grave disfunzione d’organo, in particolare di fegato, reni, cuore, polmoni -Altra patologia severa concomitante che renda inopportuno l’arruolamento del paziente nello studio -Storia di una precedente patologia vena-occlusiva (VOD) -Disturbi neuro-psichiatrici, sociali o familiari gravi che rendano difficoltosa la partecipazione del paziente allo studio -Ipersensibilità a Citarabina, Clofarabina o a Daunorubicina liposomiale - Somministrazione concomitante di altri farmaci sperimentali o concomitanti trattamenti con altri farmaci chemioterapici al di fuori di quelli specificati dal protocollo -Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    -Overall Response Rate (ORR) = CR+CRi+PR= Complete Remission+ Complete Remission without either platelets or neutrophils recovery without blasts+ Partial Remission -Complete Remission Rate (CR+Cri) -Partial Remission Rate (RP)
     ORR (RC+RCi+RP= Remissione Completa + Remissione completa senza recupero di piastrine o neutrofili in assenza di blasti + Remissione Parziale) -Tasso di remissione completa (RC+RCi) -Tasso di Remissione Parziale (RP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    66 days since the beginning of therapy
    66 giorni dall’inizio della terapia
    E.5.2Secondary end point(s)
    1)EFS (Event Free Survival), PFS (Progression Free Survival) and OS (Overall Survival) 2)Incidence of adverse grade ≥ 3 events (NCI CTAE version 4.0) excluding nausea and vomit 3)Number of patients who will proceed to HSCT
    1)Remissione libera da eventi (EFS), remissione libera da progressione (PFS), tasso di sopravvivenza (OS) 2)Incidenza di eventi avversi grado 3 durante il trattamento, secondo i criteri del CTCAE, versione 4.0,-esclusi nausea e vomito 3)Numero di pazienti che viene sottoposto a trapianto
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 12 and 18 months since the beginning of therapy 2)-3) Until HSCT
    1) A 12 e 18 mesi dall’inizio della terapia 2)-3) Fino ad esecuzione di HSCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    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
    LAST CLINICAL HEMATOLOGICAL AND INSTRUMENTAL EVALUATION OF THE LAST ENROLLED PATIENT
    L'ULTIMA VALUTAZIONE CLINICO STRUMENTALE DELL'ULTIMO PAZIENTE ARRUOLATO
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state40
    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)
    After HSCT the patients will undergo general follow up after transplantation and specific clinical and hematological and instrumental cardiac evaluation
    Successivamente all’esecuzione di HSCT i pazienti verranno sottoposti alle valutazioni previste dal follow-up specifico per il trapianto di cellule staminali ematopoietiche e a controlli clinico-ematologici e strumentali cosi come indicato nello studio ancillare, volti a monitorare la funzionalità cardiaca in pazienti sottoposti ad alte dosi di antracicline.
    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 Decision2012-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
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