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    Summary
    EudraCT Number:2019-003982-17
    Sponsor's Protocol Code Number:SGN35-015
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-06
    Trial results View 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 number2019-003982-17
    A.3Full title of the trial
    A phase 2 open-label study of brentuximab vedotin in front-line therapy of Hodgkin lymphoma (HL) and CD30-expressing peripheral T-cell lymphoma (PTCL) in older patients or patients with significant comorbidities ineligible for standard chemotherapy
    Studio in aperto di fase 2 su brentuximab vedotin nella terapia di prima linea del linfoma di Hodgkin (LH) e del linfoma periferico a cellule T (PTCL) CD30-positivo in pazienti anziani o in pazienti con comorbilità significative non idonei a chemioterapia standard.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of brentuximab vedotin with Hodgkin lymphoma (HL) and CD30-expressing peripheral T-cell lymphoma (PTCL)
    Studio su brentuximab vedotin con linfoma di Hodgkin (LH) e linfoma periferico a cellule T (PTCL) CD30-positivo
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberSGN35-015
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01716806
    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 SponsorSEATTLE GENETICS, INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSeattle Genetics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSeattle Genetics, Inc.
    B.5.2Functional name of contact pointSeagen Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address21621- 30th Drive SE, Building 4
    B.5.3.2Town/ cityBothell
    B.5.3.3Post code98021
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@seagen.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 ADCETRIS
    D.2.1.1.2Name of the Marketing Authorisation holderSeattle Genetics, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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/3/08/596; EU/3/08/595
    D.3 Description of the IMP
    D.3.1Product nameBrentuximab vedotin
    D.3.2Product code [SGN-35]
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBRENTUXIMAB VEDOTIN
    D.3.9.1CAS number 914088-09-8
    D.3.9.2Current sponsor codeSGN-35
    D.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 (HL)
    • CD30-expressing peripheral T-cell lymphoma (PTCL)
    • Linfoma di Hodgkin (LH)
    • Linfoma periferico a cellule T (PTCL) CD30-positivo
    E.1.1.1Medical condition in easily understood language
    • Hodgkin lymphoma
    • T-cell lymphoma
    • Linfoma di Hodgkin
    • Linfoma a cellule T
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10034623
    E.1.2Term Peripheral T-cell lymphoma unspecified
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10034624
    E.1.2Term Peripheral T-cell lymphoma unspecified NOS
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10073478
    E.1.2Term Anaplastic large-cell lymphoma
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10001412
    E.1.2Term Adult T-cell leukemia-lymphoma
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065855
    E.1.2Term Extranodal NK/T-cell lymphoma, nasal type
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10073481
    E.1.2Term Enteropathy-associated T-cell lymphoma
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10022703
    E.1.2Term Intestinal T-cell lymphoma
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10061232
    E.1.2Term Lymphoproliferative disorder
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10066957
    E.1.2Term Hepatosplenic T-cell lymphoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10002449
    E.1.2Term Angioimmunoblastic T-cell lymphoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10042971
    E.1.2Term T-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the response rates (ORR) of single-agent brentuximab vedotin as frontline therapy in patients age > or = 60 years and in patients ineligible for conventional combination chemotherapy due to comorbidities.
    L'obiettivo principale è di valutare i tassi di risposta (ORR) di brentuximab vedotin come agente singolo come terapia di prima linea in pazienti di età > o = 60 anni e in pazienti non idonei alla chemioterapia di combinazione tradizionale per la presenza di comorbilità.
    E.2.2Secondary objectives of the trial
    - To evaluate safety and tolerability of single-agent brentuximab vedotin
    - To assess duration of response
    - To assess complete remission (CR) rate
    - To assess progression-free survival (PFS)
    - To assess resolution of B symptoms
    - To assess pharmacokinetics and immunogenicity of brentuximab vedotin
    - To assess overall survival (OS)
    - Valutare la sicurezza e la tollerabilità di brentuximab vedotin come agente singolo
    - Valutare la durata della risposta
    - Valutare il tasso di remissione completa (CR)
    - Valutare la sopravvivenza libera da progressione (PFS)
    - Valutare la risoluzione dei sintomi B
    - Valutare la farmacocinetica e l’immunogenicità di brentuximab vedotin
    - Valutare la sopravvivenza complessiva (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study parts E and F:
    1. Treatment-naive patients with histopathological diagnosis of classical HL (Part E), or treatment-naive patients with CD30-expressing (> or = 1%) PTCL (Part F).
    2. age > or = 18 years
    3. Patients must be unsuitable or unfit for initial conventional combination chemotherapy for HL or CD30-expressing PTCL due to the presence of comorbidity-related factors, as documented by:
    a. a CIRS score > or = 10 OR
    b. requiring assistance with or dependence on others for any IADLs.
    4. Patients must have fluorodeoxyglucose (FDG)-PET-avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique.
    5. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of < or = 3
    Parti E e F dello studio:
    1. Pazienti naive al trattamento con diagnosi istopatologica di HL classica (parte E), o pazienti naive al trattamento con PTCL con espressoine di CD30 (> o = 1%) (parte F).
    2. età > o = 18 anni
    3. I pazienti devono essere non idonei o inadatti alla chemioterapia combinata convenzionale iniziale per HL o PTCL con espressione di CD-30 a causa della presenza di fattori correlati alla comorbidità, come documentato da:
    a. un punteggio CIRS > o = 10 OR
    b. richiesta di assistenza o dipendenza da altri per qualsiasi IADL.
    4. I pazienti devono avere fluorodeossiglucosio (FDG)-PET-avido e una malattia misurabile bidimensionale di almeno 1,5 cm sull'asse più lungo, come documentato dalla tecnica radiografica.
    5. Un punteggio di performance secondo l' Eastern Cooperative Oncology Group (ECOG) < o = 3
    E.4Principal exclusion criteria
    1. Baseline peripheral neuropathy Grade > or = 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
    2. History of progressive multifocal leukoencephalopathy (PML)
    3. Any active Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin. Routine antimicrobial prophylaxis is permitted.
    7. Kidney disease requiring ongoing dialysis
    15. Known cerebral/meningeal disease related to the underlying malignancy.
    17. Known to be positive for hepatitis B by surface antigen expression. Known to be positive for hepatitis C infection (positive by polymerase chain reaction [PCR]). Patients who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks
    18. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
    19. Active hepatitis C infection (positive by serology and confirmed by PCR or on antiviral therapy for hepatitis C within the last 6 months).
    21. History of another malignancy within 1 year before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
    1. Grado di neuropatia periferica di base > o = 2 o pazienti con la forma demielinizzante della sindrome di Charcot-Marie-Tooth
    2. Anamnesi di leucoencefalopatia multifocale progressiva (PML)
    3. Qualsiasi infezione virale, batterica o fungina attiva di grado 3 o superiore nelle 2 settimane prima della prima dose di vedotina brentuximab. È consentita la profilassi antimicrobica di routine.
    7. Malattie renali che richiedono una dialisi in corso
    15. Nota malattia cerebrale/meningea correlata alla malignità sottostante
    17. Essere positivo all'epatite B per espressione dell'antigene di superficie. Essere positivo per l'infezione da epatite C (positivo per reazione a catena della polimerasi [PCR]). I pazienti che sono stati trattati per l'infezione da epatite C sono ammessi se hanno una risposta virologica sostenuta di 12 settimane documentata.
    18. Nota positività ai test per il virus dell'immunodeficienza umana (HIV) o alla sindrome da immunodeficienza acquisita (AIDS).
    19. Infezione attiva da epatite C (positiva per sierologia e confermata dalla PCR o da una terapia antivirale per l'epatite C negli ultimi 6 mesi).
    21. Anamnesi di un'altra neoplasia maligna nell'anno prima della prima dose del farmaco in studio o qualsiasi evidenza di malattia residua da una neoplasia maligna diagnosticata in precedenza. Fanno eccezione i tumori maligni con un rischio trascurabile di metastasi o di morte.
    E.5 End points
    E.5.1Primary end point(s)
    ORR according to modified Lugano criteria. The assessment will be per blinded independent central review (BICR)
    ORR secondo i criteri di Lugano modificati. La valutazione sarà effettuata per esame centrale indipendente in cieco (blinded independent central review, BICR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through 1 month following last dose; up to approximately 18 months
    Per 1 mese dopo l'ultima dose; fino a circa 18 mesi
    E.5.2Secondary end point(s)
    - Type, incidence, severity, seriousness, and relatedness of AEs and laboratory abnormalities
    - CR rate, disease control rate, duration of ORR, duration of CR, and PFS
    - ORR according to Lugano criteria per BICR
    - B symptom resolution rate
    - Estimates of selected PK parameters
    - Incidence of antitherapeutic antibodies (ATA) to brentuximab vedotin
    - OS
    - Tipo, incidenza, gravità e correlazione di AE e anomalie di laboratorio
    - Tasso di CR, tasso di controllo della malattia, durata dell'ORR, durata della CR e PFS
    - ORR secondo i criteri di Lugano per BICR
    - Tasso di risoluzione dei sintomi B
    - Stime dei parametri PK selezionati
    - Incidenza di anticorpi antiterapeutici (ATA) contro brentuximab vedotin
    - OS
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Through 1 month following last dose; up to approximately 18 months
    • Up to approximately 5 years
    • Through 1 month following last dose; up to approximately 18 months
    • Through 1 month following last dose; up to approximately 18 months
    • At each treatment cycle
    • Through 1 month following last dose; up to approximately 18 months
    • Up to approximately 5 years
    • Per 1 mese dopo l'ultima dose; fino a circa 18 mesi
    • Fino a circa 5 anni
    • Per 1 mese dopo l'ultima dose; fino a circa 18 mesi
    • Per 1 mese dopo l'ultima dose; fino a circa 18 mesi
    • Ad ogni ciclo di trattamento
    • Per 1 mese dopo l'ultima dose; fino a circa 18 mesi
    • Fino a circa 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and Immunogenicity
    Tollerabilità ed Immunogenicità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Italy
    Poland
    United States
    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
    The study will be closed 2 years after the last patient receives their lastdose or when the last patient completes the last visit, last contact, discontinues from the study, or when no patients remain in follow-up, whichever occurs first. In addition, the sponsor may terminate the study at any time.
    Lo studio sarà chiuso 2 anni dopo che l'ultimo paziente avrà ricevuto la sua ultima dose o quando l'ultimo paziente completerà l'ultima visita, l'ultimo contatto, avrà interrotto lo studio, o quando non ci sarà più alcun paziente rimasto in follow-up, qualsiasi di questi avvenga prima. In aggiunta, il Promotore può concludere lo studio in qualsiasi momento.
    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 years13
    E.8.9.2In all countries concerned by the trial months3
    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) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    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)
    Not applicable
    Non applicabile
    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 Decision2020-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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