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    EudraCT Number:2013-000182-37
    Sponsor's Protocol Code Number:BREACH
    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:2015-02-24
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000182-37
    A.3Full title of the trial
    Brentuximab vedotin associated with chemotherapy in untreated patients with stage I/II unfavourable Hodgkin lymphoma. A randomized phase II LYSAFIL-EORTC intergroup study
    Brentuximab Vedotin in associazione con chemioterapia nel trattamento di prima linea di pazienti con diagnosi di Linfoma di Hodgkin sfavorevole in stadio I-II. Studio intergruppo randomizzato di fase II LYSA-FIL-EORTC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brentuximab vedotin associated with chemotherapy in untreated patients with stage I/II unfavourable Hodgkin lymphoma
    Brentuximab associato a chemioterapia come trattamento di prima linea di pazienti con Linfoma di Hodgkin stadio I-II sfavorevole
    A.4.1Sponsor's protocol code numberBREACH
    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 SponsorLYSARC
    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 supportMillennium: The Takeda Oncology Company
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportLYSARC
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr Luc-Matthieu Fornecker
    B.5.2Functional name of contact pointCo-coordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressCHU Strasbourg, Service Hématologie Hautepierre, Hôpital de Hautepierre, BP. 428
    B.5.3.2Town/ cityStrasbourg
    B.5.3.3Post code67098
    B.5.4Telephone number0033388127676
    B.5.5Fax number0033388127681
    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. name Adcetris (Brentuximab Vedotin)
    D. of the Marketing Authorisation holderTakeda Global Research and Development Centre (Europe) Ltd
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBrentuximab Vedotin
    D.3.2Product code SGN-01
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Hodgkin Lymphoma
    Linfoma di Hodgkin
    E.1.1.1Medical condition in easily understood language
    Hodgkin Lymphoma
    Linfoma di Hodgkin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To improve the PET negativity after two cycles of immuno-chemotherapy
    Aumentare la percentuale PET negatività dopo due cicli di immunochemioterapia
    E.2.2Secondary objectives of the trial
    Secondary efficacy endpoint:
    - CR rate (according to Cheson 2007) at the end of treatment
    - Progression-free survival (PFS)
    - Overall survival

    Secondary safety endpoint:
    - Toxicity of brentuximab vedotin in combination with combined modality treatment
    Endpoint secondari di efficacia:
    - percentuale di risposte complete (RC) alla fine del trattamento; la
    valutazione della risposta è prevista secondo i criteri di Cheson 2007
    - sopravvivenza libera da progressione (PFS)
    - sopravvivenza globale (OS)

    Endpoint secondario di sicurezza:
    - Tossicità del brentuximab vedotin associato a un trattamento combinato di chemioradioterapia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed CD30+ classical Hodgkin lymphoma according to local evaluation
    - Supradiaphragmatic Ann Arbor clinical stage I or II
    - Previously untreated
    - PET scan without IV contrast at diagnosis available for central review with at least one hypermetabolic lesion
    - Unfavourable (U) characteristics according to the classic EORTC/LYSA clinical prognostic factors. Unfavourable (U) subset includes patients with at least one of the following factors:
    a) CSII ≥ 4 nodal areas
    b) age ≥ 50 yrs
    c) M/T ratio ≥ 0.35
    d) ESR ≥ 50 (without B-symptoms) or ESR ≥ 30 with B-symptoms
    - ECOG performance status 0-2
    - Life expectancy > 6 months
    - Age 18 to 60 years (≥ 18 years to ≤ 60 years)
    - Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
    - Female patients who:
    a) Are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile,
    b) If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agree to
    completely abstain from heterosexual intercourse
    - Male patients, even if surgically sterilized (ie, status postvasectomy), who:
    a) Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
    - Patients must give written informed consent. A copy of the informed signed consent form will be retained in the patient’s chart.
    - Required baseline laboratory data:
    a) Absolute neutrophil count ≥ 1,500/µL    
    b) Platelet count ≥ 75,000/ µL
    c) Hemoglobin ≥ 8g/dL
    d) Serum total bilirubin ≤ 1.5 X ULN unless the elevation is known to be due to Gilbert syndrome.
    e) Serum creatinine ≤ 2.0 mg/dL and/or calculated creatinine clearance > 40 mL/minute (Cockcroft-Gault formula or MDRD)
    f) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN

    - Diagnosi locale confermata istologicamente di linfoma di Hodgkin classico
    CD30 positivo
    - Localizzazione sovradiaframmatica di malattia in stadio di Ann-Arbor I-II
    - Pazienti vergini da precedenti trattamenti
    - PET/TAC senza mezzo di contrasto basale che documenti almeno una lesione ipermetabolica disponibile per la revisione centralizzata
    - Malattia con profilo di rischio Sfavorevole (U) secondo i criteri EORTC/LYSA. Sulla base di questi criteri un paziente viene definito a rischio Sfavorevole (U) se presenta almeno uno dei seguenti fattori:
    a) stadio clinico II con ≥ 4 aree nodali [NB: le aree nodali al di sopra del diaframma sono in tutto 5: cervicale destra e sinistra, mediastino, ascellare destra e sinistra; più lesioni nodali in una stessa area devono essere conteggiate come un’unica area coinvolta]
    b) età ≥ 50 anni
    c) M/T ratio (rapporto mediastino/torace) ≥ 0.35
    d) VES ≥ 50 (in assenza di sintomi B) o VES ≥ 30 in presenza di sintomi B
    - ECOG performance status 0-2
    - Aspettativa di vita > 6 mesi
    - Età 18-60 anni (≥ 18 anni e ≤ 60 anni)
    - Disponibilità dei pazienti ad eseguire gli esami di laboratorio periodici previsti dal protocollo, a sottoporsi alle valutazioni strumentali e a tutte le procedure previste dallo studio, incluse visite periodiche per la valutazione di eventualieventi avversi da pianificare presso la struttura dove ricevono il trattamento.
    - Pazienti femmine in menopausa conclamata da almeno un anno al momento della visita di screening oppure sterili per procedura chirurgica; donne in età fertile possono essere incluse se acconsentono ad adottare due diversi metodi contraccettivi sicuri contemporaneamente dal momento in cui firmano il consenso informato fino a 6 mesi dopo l’ultima dose di trattamento secondo protocollo oppure se accettano di astenersi completamente da rapporti
    eterosessuali per lo stesso periodo
    - Pazienti maschi, anche se sottoposti a vasectomia, che acconsentano ad adottare metodi contraccettivi di barriera sicuri per tutto il periodo di durata del trattamento e fino a 6 mesi dopo avere ricevuto l’ultima dose di trattamento o che acconsentano ad astenersi completamente da rapporti eterosessuali per lo stesso periodo
    - Pazienti che rilascino un consenso informato scritto. Una copia del consensoinformato firmato dovrà essere conservata nella documentazione del paziente.
    - Pazienti con i seguenti valori di laboratorio alla diagnosi:
    a) Conta assoluta dei neutrofili (ANC) ≥ 1,500/µL
    b) Piastrine ≥ 75,000/ µL
    c) Emoglobina ≥ 8g/dL
    d) Bilirubina sierica totale ≤ 1.5 volte il limite superiore di normalità, a meno che il valore elevato sia dovuto ad accertata sindrome di Gilbert.
    e) Creatinina sierica ≤ 2.0 mg/dL e/o clearance della creatinina calcolata > 40 mL/minuto (formula di Cockcroft-Gault o formula MDRD)
    f) Alanina aminotransferasi (ALT, GPT) e aspartato amino transferasi (AST, GOT) ≤ 3 volte il limite superiore di normalità

    E.4Principal exclusion criteria
    - Histological diagnosis different from classical Hodgkin Lymphoma. Nodular lymphocyte predominant subtypes (nodular paragranuloma or Poppema paragranuloma) are excluded
    - Known cerebral or meningeal disease of any etiology, including signs or symptoms of PML
    - Any sensory or motor peripheral neuropathy ≥ Grade 2
    - Known history of any of the following cardiovascular conditions
    a) Myocardial infarction within 2 years of randomization
    b) New York Heart Association (NYHA) Class III or IV heart failure
    c) Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction
    system abnormalities
    d) Recent evidence (within 30 days before first dose of study drug) of a leftventricular ejection
    fraction <50%
    - Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan).
    - Known HIV positive
    - HCV positive
    - HBV positive. This means:
    a) HBsAg positive
    b) HBsAg negative, anti-HBs positive and/or anti-HBc positive and
    detectable viral DNA
    c) Note:
    * Patients who are HBsAg negative and viral DNA negative are eligible
    * Patients who are seropositive due to a history of hepatitis B vaccine are eligible.
    - Any history of cancer during the last 5 years, with the exception of nonmelanoma skin tumors. Carcinoma
    in situ of any type are not excluded if they have undergone complete resection.
    - Dementia or altered mental status that would preclude compliance with drug delivery
    - Pregnancy or breastfeeding. Females of childbearing potential having a positive β-HCG pregnancy test result during screening or a positive pregnancy test (urinary or blood) within 1 day before start of treatment.
    - Previous treatment with any anti-CD30 antibody
    - Known hypersensitivity to any excipients contained in the brentuximabvedotin formulation or known contra-indication to any drug contained in thechemotherapy regimens (for ex.: pulmonary or neurological disease grade ≥2)
    - Treatment with corticosteroids before baseline PET scan (PET-0)
    - Patients with known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy or with untreated known active Grade 3 viral, bacterial, or fungal infection, within 2 weeks prior to the first dose of brentuximab vedotin
    - Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy or immuno-chemotherapy

    - Diagnosi istologica diversa da quella di linfoma di Hodgkin classico. I sottotipi di Linfoma di Hodgkin a prevalenza linfocitaria (nodular paragranuloma o Poppema paragranuloma) sono esclusi.
    - Presenza di malattia cerebrale o meningea di qualsiasi eziologia, inclusi segni o sintomi di Leucoencefalopatia Multifocale Progressiva
    - Qualsiasi neuropatia sensoriale o motoria di grado ≥ 2
    - Storia clinica di una qualsiasi delle seguenti patologie cardiovascolari:
    a) Infarto miocardico nei 2 anni precedenti l’entrata in studio
    b) Insufficienza cardiaca di Classe III-IV secondo la classificazione NYHA (New York Heart Association)
    c) Evidenza di patologie cardiache non controllate in atto, incluse aritmie cardiache, insufficienza cardiaca congestizia, angina o evidenza elettrocardiografica di ischemia acuta o anomalie del sistema di conduzione
    d) Riscontro recente (nei 30 giorni prima della somministrazione della prima
    dose del trattamento previsto dal protocollo) di una LVEF <50%
    - Diabete mellito non controllato (per evitare di avere FDG-PET non interpretabili)
    - Pazienti HIV positivi
    - Pazienti HCV positivi
    - Pazienti HBV positivi, intendendo con questo:
    a) Pazienti HBsAg positivi
    b) Pazienti con HBsAg negativo, anti-HBs positivo e/o anti-HBc positivo e ricerca di DNA virale positiva
    * Pazienti HBsAg negativi e DNA virale negativi sono eleggibili
    * Pazienti sieropositivi per storia clinica di Epatite B o perché vaccinati
    sono eleggibili
    - Qualsiasi precedente diagnosi di neoplasia negli ultimi 5 anni, fatta eccezione per tumori della cute non melanomatosi e carcinomi in situ di qualsiasi tipo purché siano stati trattati con resezione chirurgica completa
    - Demenza o altre condizioni mentali o psicologiche che rendano il paziente non compliante al trattamento secondo protocollo
    - Gravidanza o allattamento. Donne in età fertile con β-HCG positivo durante le
    procedure di screening o con un test di gravidanza positivo (eseguito su urine o sangue) entro il giorno prima l’inizio della somministrazione della prima dose di trattamento
    - Precedente trattamento con qualsiasi anticorpo monoclonale anti-CD30
    - Ipersensibilità nota a qualsiasi eccipiente contenuto nella formulazione di brentuximab vedotin o controindicazione nota alla somministrazione di uno dei farmaci previsti dalla schedula di chemioterapia del protocollo (ad es. patologie polmonari o neurologiche di grado ≥ 2)
    - Trattamento con steroidi prima della PET basale (PET-0)
    - Pazienti con infezione virale, batterica o fungina attiva che richieda trattamento con terapia antimicrobica o con infezione virale, batterica o fungina attiva nota di grado 3 riscontrata fino a 2 settimane prima della somministrazione della prima dose di brentuximab vedotin
    - Trattamento con qualsiasi altro farmaco sperimentale nei 30 giorni prima del
    previsto primo ciclo di chemioterapia o chemioimmunoterapia
    E.5 End points
    E.5.1Primary end point(s)
    PET 2 assessment according to the five-point scale Deauville criteria (Negative = 1, 2, 3 and Positive = 4, 5), based on central review.
    Valutazione della PET 2 secondo i criteri di Deaville (five-point scale): PET negativa: score 1,2,3; PET positiva: score 4,5. Lo score viene definito mediante revisione centralizzata delle PET.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 2 cycles of chemotherapy or immuno-chemotherapy (ABVD or AVD/Brentuximab vedotin)- 2 months
    Dopo due cicli di chemioterapia o immuno-chemioterapia (ABVD o AVD/Brentuximab vedotin)- 2 mesi
    E.5.2Secondary end point(s)
    Secondary efficacy endpoint:
    - CR rate (according to Cheson 2007) at the end of treatment
    - Progression-free survival (PFS)
    - Overall survival

    Secondary safety endpoint:
    - Toxicity of brentuximab vedotin in combination with combined modality
    Endpoint secondari di efficacia:
    - percentuale di risposte complete (RC) alla fine del trattamento; la valutazione della risposta è prevista secondo i criteri di Cheson 2007
    - sopravvivenza libera da progressione (PFS)
    - sopravvivenza globale (OS)

    Endpoint secondario di sicurezza:
    - Tossicità del brentuximab vedotin associato a un trattamento combinato
    di chemioradioterapia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoint:
    - Disease response evaluation at end of treatment (after radiotherapy) will be used to determine the Response Rate.
    - PFS is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of last visit assessment.
    - Overall survival will be measured from date of randomization into the study to the date of death from any cause.

    Secondary safety endpoint:
    - End of treatment
    Endpoint secondari di efficacia:
    - La valutazione della risposta alla fine del trattamento (dopo radioterapia) sarà utilizzato per valutare il tasso di risposta (6 mesi circa)
    - PFS sarà definita come il tempo dalla randomizzazione nello studio fino a progressione o morte per qualsiasi causa. Se per un soggetto non si verificano progressione o morte, la PSF sarà valutata al tempo dell’ultima visita effettuata.
    - OS sarà misurata dalla data di randomizzazione nello studio fino alla data di morte per qualsiasi causa.

    Endpoint secondario di sicurezza:
    - Fine del trattamento (6 mesi circa)
    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. 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 No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned41
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months8
    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) Yes
    F.1.2.1Number of subjects for this age range: 170
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 170
    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 treatment, if necessary, the patiennts will receive a salvage treatment according to local investigator
    Alla fine del trattamento, se necessario, i pazienti riceveranno una terapia di salvataggio a discrezione dello sperimentatore locale.
    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 Decision2015-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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