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    Summary
    EudraCT Number:2019-003983-28
    Sponsor's Protocol Code Number:SGN35-028
    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:2021-05-25
    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 number2019-003983-28
    A.3Full title of the trial
    A phase 2, multicenter, single-arm study of retreatment with brentuximab vedotin in subjects with relapsed or refractory classic Hodgkin lymphoma
    (cHL) or CD30-expressing peripheral T cell lymphoma (PTCL)
    Studio di fase 2, multicentrico, a braccio singolo, di ritrattamento con brentuximab vedotin in soggetti affetti da linfoma di Hodgkin classico (cLH) o linfoma periferico a cellule T (PTCL) CD30-positivo recidivante o refrattario.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 study of retreatment with brentuximab vedotin in subjects with classic Hodgkin lymphoma or CD30-expressing peripheral T cell lymphoma
    Studio di fase 2 di ritrattamento con brentuximab vedotin in soggetti affetti da linfoma di Hodgkin classico o linfoma periferico a cellule T CD30-positivo
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberSGN35-028
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03947255
    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 SponsorSEAGEN 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.5.4Telephone number000000
    B.5.5Fax number000000
    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 INN00326900
    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
    - classic Hodgkin lymphoma (cHL)
    - Systemic anaplastic large cell lymphoma (sALCL)
    - CD30-expressing peripheral T cell lymphoma (PTCL)
    - linfoma di Hodgkin classico (cHL)
    - Linfoma anaplastico sistemico a grandi cellule (sALCL)
    - Linfoma a cellule T periferiche che esprimono CD30 (PTCL)
    E.1.1.1Medical condition in easily understood language
    - Hodgkin lymphoma
    - Lymphoma
    - T cell lymphoma
    - Linfoma di Hodgkin
    - Linfoma
    - 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 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 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 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
    - To assess the antitumor response by blinded independent central review (BICR) of brentuximab vedotin retreatment
    - To assess the safety of retreatment with brentuximab vedotin
    - Valutare la risposta antitumorale mediante revisione centrale indipendente in cieco (BICR) del ritrattamento con brentuximab vedotin
    - Valutare la sicurezza del ritrattamento con brentuximab vedotin
    E.2.2Secondary objectives of the trial
    - To assess duration of tumor control, including duration of response (DOR) as determined by BICR
    - To assess progression-free survival (PFS) of retreatment with brentuximab vedotin as determined by BICR
    - To assess overall survival (OS)
    - To assess complete response (CR) rate per BICR
    - To assess the antitumor response per investigator of brentuximab vedotin retreatment
    - To assess DOR rate per investigator assessment
    - To assess PFS per investigator assessment
    - To assess CR rate per investigator assessment
    - To assess ORR as determined by BICR
    - valutare la durata del controllo del tumore, inclusa la durata della risposta (DOR) determinata da BICR
    - valutare la sopravvivenza libera da progressione (PFS) del ritrattamento con brentuximab vedotin come determinato da BICR
    - valutare la sopravvivenza globale (OS)
    - valutare il tasso di risposta completa (CR) secondo BICR
    - valutare la risposta antitumorale del ritrattamento con brentuximab vedotin secondo lo sperimentatore
    - valutare il tasso di DOR secondo valutazione dello sperimentatore
    - valutare la PFS secondo valutazione dello sperimentatore
    - valutare il tasso di CR secondo valutazione dello sperimentatore
    - valutare l'ORR come determinato da BICR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL.
    - Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or
    relapse after discontinuing treatment.
    - Documentation of disease relapse or progression > o = 6 months after the last dose of brentuximab vedotin.
    - Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis
    as documented by radiographic technique.
    - An Eastern Cooperative Oncology Group (ECOG) performance status < o = 2.
    - Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and
    for 6 months following last dose of study drug.
    - Age 18 or older.

    Other protocol defined inclusion criteria may apply.
    - Linfoma di Hodgkin classico (cHL), linfoma anaplastico sistemico a grandi cellule (sALCL) o altro linfoma a cellule T periferiche (PTCL) esprimente CD30 istologicamente confermato. Precedentemente trattati con regime contenente brentuximab vedotin, con evidenza di risposta obiettiva e successiva progressione della malattia o recidiva dopo l’interruzione del trattamento.
    - Documentazione della recidiva o della progressione della malattia > o = 6 mesi dopo l’ultima dose di brentuximab vedotin.
    - Malattia misurabile mediante tomografia ad emissione di positroni a base di fluorodesossiglucosio (FDG-PET) avida
    e bidimensionale di almeno 1,5 cm nell’asse più lungo come documentato dalla tecnica radiografica.
    - Stato di performance secondo l’Eastern Cooperative Oncology Group (ECOG) < o = 2
    - Non deve avere una gravidanza in corso e, se in età fertile o soggetto maschile in grado di concepire,
    deve accettare di utilizzare 2 metodi contraccettivi efficaci nel corso dello studio e per 6 mesi dopo l’ultima dose del farmaco dello studio.
    - Età o superiore a 18 anni.

    Potrebbero applicarsi criteri di inclusione aggiuntivi definiti dal protocollo.
    E.4Principal exclusion criteria
    - Subjects who previously discontinued brentuximab vedotin due to any
    Grade 3 or higher toxicity.
    - Subjects with existing Grade 2 or higher peripheral neuropathy.
    - Subjects who were previously refractory to treatment with brentuximab vedotin.
    - Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to
    their first dose of brentuximab vedotin.
    - History of another malignancy within 3 years 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.
    - Subjects with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis
    agent against GvHD.
    - Active cerebral/meningeal disease.
    - History of progressive multifocal leukoencephalopathy (PML).
    - Any active uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for AEs, NCI CTCAE Version
    5.0) viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of brentuximab vedotin in this study.
    - Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to
    first dose of study drug, unless underlying disease has progressed on treatment.
    - Subjects < 100 days from allogeneic transplant.
    - Post-allogeneic transplant subjects with any detectable level of cytomegalovirus (CMV) by polymerase chain reaction (PCR).
    - Prior donor lymphocyte infusion < 8 weeks prior to first dose of study drug.

    Other protocol defined exclusion criteria may apply.
    - Soggetti che in precedenza hanno sospeso l’assunzione di brentuximab vedotin a causa di una qualsiasi tossicità di Grado 3 o superiore.
    - Soggetti con neuropatia periferica in atto di Grado 2 o superiore.
    - Soggetti precedentemente refrattari al trattamento con brentuximab vedotin.
    - Anamnesi documentata di evento cerebrovascolare, angina instabile, infarto del miocardio o sintomi cardiaci nei 6 mesi precedenti la prima dose di brentuximab vedotin.
    - Anamnesi di altra malignità nei 3 anni precedenti la prima dose del farmaco dello studio o qualsiasi evidenza di malattia residua da una malignità precedentemente diagnosticata. Costituiscono eccezioni le malignità con un rischio trascurabile di metastasi o decesso.
    - Soggetti con malattia da trapianto contro l’ospite (GvHD) cronica o acuta o che ricevono una terapia immunosoppressiva come trattamento o un agente di profilassi contro la GvHD.
    - Malattia cerebrale/meningea attiva.
    - Anamnesi di leucoencefalopatia multifocale progressiva (LMP).
    - Qualsiasi infezione virale, batterica o fungina attiva non controllata di Grado 3 o superiore (secondo i Criteri terminologici comuni per gli eventi avversi del National Cancer Institute [NCI CTCAE] versione 5.0) che richieda un trattamento con terapia antimicrobica entro le 2 settimane precedenti la prima dose di brentuximab vedotin in questo studio.
    - Chemioterapia, radioterapia, agenti biologici e/o altro trattamento antitumorale con immunoterapia che non sia completato nelle 4 settimane precedenti la prima dose del farmaco dello studio, a meno che la malattia di base abbia subito una progressione durante il trattamento.
    - Soggetti a < 100 giorni dal trapianto allogenico.
    - Soggetti in fase post-trapianto allogenico con qualsiasi livello rilevabile di citomegalovirus (CMV) mediante reazione a catena della polimerasi (PCR).
    - Precedente infusione di linfociti da donatore < 8 settimane precedenti la prima dose del farmaco dello studio.

    Potrebbero applicarsi criteri di esclusione aggiuntivi definiti dal protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    - BICR reporting of objective response rate (ORR) per modified Lugano response criteria
    - Type, incident, severity, seriousness, and relatedness of adverse events (AEs)
    - Type, incidence, and severity of laboratory abnormalities
    - Reporting BICR del tasso di risposta obiettiva (ORR) per criteri di risposta Lugano modificati
    - Tipo, incidente, gravità e correlazione degli eventi avversi (EA)
    - Tipo, incidenza e gravità delle anomalie di laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    - BICR reporting of objective response rate (ORR) per modified Lugano response criteria: Up to approximately 1 year
    - Type, incident, severity, seriousness, and relatedness of adverse events (AEs): Up to approximately 5 years
    - Type, incidence, and severity of laboratory abnormalities: Up to approximately 1 year
    - Rapporto BICR del tasso di risposta oggettiva (ORR) secondo i criteri di risposta Lugano modificati: fino a circa 1 anno
    - Tipo, incidente, gravità e correlazione degli eventi avversi (EA): fino a circa 5 anni
    - Tipo, incidenza e gravità delle anomalie di laboratorio: fino a circa 1 anno
    E.5.2Secondary end point(s)
    - BICR reporting of DOR per modified Lugano response criteria
    - BICR reporting of PFS per modified Lugano response criteria
    - OS
    - Rate of CR per BICR per modified Lugano response criteria
    - Investigator reporting of ORR per modified Lugano response criteria
    - Investigator reporting of DOR per modified Lugano response criteria
    - Investigator reporting of PFS per modified Lugano response criteria
    - Rate of CR per investigator per modified Lugano response criteria
    - BICR reporting of ORR per Lugano response criteria
    - Reporting BICR del DOR secondo i criteri di risposta Lugano modificati
    - Segnalazione BICR della PFS in base ai criteri di risposta Lugano modificati
    - OS
    - Tasso di CR per BICR secondo i criteri di risposta Lugano modificati
    - Segnalazione da parte dello sperimentatore dell'ORR in base ai criteri di risposta Lugano modificati
    - Segnalazione da parte dello sperimentatore del DOR in base ai criteri di risposta Lugano modificati
    - Segnalazione da parte dello sperimentatore di PFS in base ai criteri di risposta Lugano modificati
    - Tasso di CR secondo lo sperimentatore secondo i criteri di risposta Lugano modificati
    - Rendicontazione BICR dell'ORR secondo criteri di risposta Lugano
    E.5.2.1Timepoint(s) of evaluation of this end point
    - BICR reporting of DOR per modified Lugano response criteria: Up to approximately 5 years
    - BICR reporting of PFS per modified Lugano response criteria: Up to approximately 5 years
    - OS: Up to approximately 5 years
    - Rate of CR per BICR per modified Lugano response criteria: Up to approximately 1 year
    - Investigator reporting of ORR per modified Lugano response criteria: Up to approximately 1 year
    - Investigator reporting of DOR per modified Lugano response criteria: Up to approximately 5 years
    - Investigator reporting of PFS per modified Lugano response criteria: Up to approximately 5 years
    - Rate of CR per investigator per modified Lugano response criteria: Up to approximately 5 years
    - BICR reporting of ORR per Lugano response criteria: Up to approximately 1 year
    - Reporting BICR del DOR secondo i criteri di risposta Lugano modificati: Fino a circa 5 anni
    - Segnalazione BICR della PFS in base ai criteri di risposta Lugano modificati: Fino a circa 5 anni
    - OS: Fino a circa 5 anni
    - Tasso di CR per BICR secondo i criteri di risposta Lugano modificati: Fino a circa 1 anno
    - Segnalazione da parte dello sperimentatore dell'ORR in base ai criteri di risposta Lugano modificati: Fino a circa 1 anno
    - Segnalazione da parte dello sperimentatore del DOR in base ai criteri di risposta Lugano modificati: Fino a circa 5 anni
    - Segnalazione da parte dello sperimentatore di PFS in base ai criteri di risposta Lugano modificati: Fino a circa 5 anni

    Fare riferimento al protocollo per ulteriori dettagli
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    United States
    France
    Italy
    Poland
    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 subject receives their last dose or when the last subject completes the last visit, last contact, discontinues from the study, or when no subjects remain in follow-up, whichever occurs first. In addition, the sponsor may terminate the study at any time.
    Lo studio verrà chiuso 2 anni dopo che l'ultimo soggetto riceve la sua ultima dose o quando l'ultimo soggetto completa l'ultima visita, l'ultimo contatto, interrompe lo studio o quando nessun soggetto rimane in follow-up, a seconda di quale condizione si verifica per prima. Inoltre, il Promotore può interrompere lo studio in qualsiasi momento.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 80
    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)
    Patients will be treated according to standard clinical practice after the end of the study
    I pazienti verranno trattati secondo la pratica clinica standard dopo la fine dello studio
    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 Decision2020-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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