Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-002382-33
    Sponsor's Protocol Code Number:NBK132/1/2020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-01
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-002382-33
    A.3Full title of the trial
    Radiation-Free Therapy for the Initial treatment of Good prognosis early non-bulky HL, defined by a low Metabolic Tumor Volume and a negative interim PET after 2 chemotherapy cycles- RAFTING
    Tratamiento inicial sin radioterapia para el linfoma de Hodgkin en estadios iniciales sin enfermedad voluminosa de buen pronóstico, definido por un
    volumen metabólico tumoral bajo y una PET intermedia negativa después de 2 ciclos de quimioterapia - RAFTING
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Radiation-Free Therapy for the Initial treatment of Good prognosis early non-bulky HL, defined by a low Metabolic Tumor Volume and a negative interim PET after 2 chemotherapy cycles- RAFTING
    Tratamiento inicial sin radioterapia para el linfoma de Hodgkin en estadios iniciales sin enfermedad voluminosa de buen pronóstico, definido por un
    volumen metabólico tumoral bajo y una PET intermedia negativa después de 2 ciclos de quimioterapia - RAFTING
    A.4.1Sponsor's protocol code numberNBK132/1/2020
    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 SponsorMedical University of Gdansk
    B.1.3.4CountryPoland
    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 supportMedical Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Gdansk
    B.5.2Functional name of contact pointJan Maciej Zaucha
    B.5.3 Address:
    B.5.3.1Street AddressSmoluchowskiego 17
    B.5.3.2Town/ cityGdańsk
    B.5.3.3Post code80-214
    B.5.3.4CountryPoland
    B.5.4Telephone number0048585844340
    B.5.5Fax number0048585844350
    B.5.6E-mailjzaucha@gumed.edu.pl
    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 OPDIVO
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNivolumab
    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 INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 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
    Early stage classical Hodgkin Lymphoma (cHL) without bulky lesions and constitutional symptoms
    Linfoma de Hodgkin clásico en estadio inicial (LHc) sin enfermedad voluminosa ni síntomas constitucionales
    E.1.1.1Medical condition in easily understood language
    Classic Hodgkin Lymphoma (cHL)
    Linfoma de Hodgkin clásico (LHc)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080208
    E.1.2Term Classical Hodgkin 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 explore the efficacy, in terms of 3-Y-itting PFS of chemotherapy alone in low-risk early-stage I-IIA HL patients, defined by a low MTV and a negative interim PET after 2 courses of ABVD.
    Evaluar la eficacia, desde el punto de vista de la SSP al cabo de 3 años, cuando se administra solo quimioterapia a pacientes con LH en estadios iniciales (estadios I-IIA) de riesgo bajo, esto es, que presenten un VMT bajo y un resultado negativo en la PET intermedia tras 2 tandas de ABVD.
    E.2.2Secondary objectives of the trial
    1. To explore the efficacy in terms of 3-Y PFS of CMT plus Nivolumab in high-risk eHL, defined either by a positive PET-2 or a high baseline MTV or both.
    2. To explore the efficacy in terms of 3-Y freedom from 2nd treatment failure (3-Y FF2TF) of chemotherapy followed by radiotherapy “on demand” plus Nivolumab maintenance in patients relapsing with the pattern of “limited relapse” (see below) for the entire group of low-risk patients (with low MTV and negative PET-2), in terms
    3. To explore the safety in terms of 3-Y OS of a treatment with chemotherapy alone in low-risk early-stage (I-IIA) HL patients, defined by a low Metabolic Tumor Volume negative interim PET after 2 ABVD courses.
    4. To evaluate the ability of cell-free DNA (cfDNA) assay to detect an impending relapse during follow-up in low-risk patients treated with chemotherapy alone.
    1. Eficacia de CMT y nivolumab desde el punto de vista de la SSP a 3 años en pacientes con LHei de riesgo alto
    2. Eficacia de la quimioterapia, seguida de la administración de radioterapia a demanda y de un tratamiento de mantenimiento con nivolumab, desde el punto de vista de la ausencia de un segundo fracaso del tratamiento al cabo de 3 años, en pacientes con el patrón de "recidiva limitada" de la totalidad del grupo de pacientes de riesgo bajo
    3. Seguridad del tratamiento quimioterápico en monoterapia desde el punto de vista de la SG al cabo de 3 años en pacientes con LH en estadios iniciales (estadios I-IIA) de riesgo bajo, esto es, que presenten un volumen metabólico tumoral bajo y un resultado negativo en la PET intermedia tras 2 tandas de ABVD.
    4. Capacidad del ADNsc para detectar la recidiva inminente durante el seguimiento en pacientes de riesgo bajo que reciban únicamente tratamiento quimioterápico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 18-60 years;
    2. Treatment-naïve, HL patients with Ann Arbor stage I or II A non-bulky disease stratified according to modified EORTC Criteria (refer to Appendix A);
    3. Patients must have a histologically confirmed diagnosis of classical HL according to the current World Health Organization Classification (nodular sclerosis, mixed cellularity, lymphocytes rich, lymphocytes depleted, or classical HL NOS [not otherwise specified]);
    4. ECOG performance status 0-2
    5. Hemoglobin must be > 8 gr./dL
    6. Absolute neutrophil count > or = 1,000/microL
    7. Platelet count > or = 100,000/microL.
    8. Voluntary written consent to take part to the study
    9. Serum Creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute
    10. Total Bilirubin <2 x upper limit of normal, unless known Gilberts syndrome.
    11. ALT or AST <3 x the upper limit of normal. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of HL in liver
    12. Female patients, if postmenopausal for at least 1 year before enrolment or, if fertile, agreeing to practice 2 effective methods of contraception or agreeing to practice true abstinence.
    13. Male patients should agree to practice barrier contraception or to practice abstinence
    1. Pacientes de ambos sexos de entre 18 y 60 años;
    2. Pacientes con LH sin enfermedad voluminosa, que no hayan recibido tratamiento previo, en estadio I o II A de acuerdo con la clasificación de Ann Arbor, estratificados de acuerdo con los criterios EORTC modificados (véase el anexo A);
    3. Los pacientes deberán presentar LH clásico (confirmado histológicamente), de acuerdo con la clasificación vigente de la Organización Mundial de la Salud (esclerosis nodular, celularidad mixta, rico en linfocitos, depleción linfocítica o linfoma de Hodgkin clásico, ENE [enfermedad no especificada]);
    4. Categoría funcional ECOG de 0 a 2
    5. Concentración de hemoglobina > 8 g/dl
    6. Recuento absoluto de neutrófilos (RAN) > o = 1000/microL
    7. Recuento de plaquetas > o = 100 000/microL
    8. Haber proporcionado voluntariamente el consentimiento por escrito para participar en el estudio
    9. Concentración sérica de creatinina <2,0 mg/dl y/o aclaramiento de creatinina o aclaramiento calculado de creatinina > 40 ml/minuto
    10. Bilirrubina total <2 veces el límite superior de la normalidad, a menos que la persona presente Síndrome de Gilbert.
    11. Concentración de ALT o AST <3 veces el límite superior de la normalidad. La concentración de AST y ALT puede estar elevada hasta 5 veces el LSN si la elevación puede justificarse razonablemente por la presencia de LH en el hígado
    12. Pacientes femeninas: deben haber entrado en la menopausia al menos 1 año antes del reclutamiento o, en caso de poder quedarse embarazadas, deben estar de acuerdo en utilizar 2 métodos anticonceptivos eficaces o en practicar la abstinencia real.
    13. Los pacientes varones deben estar de acuerdo en utilizar un método anticonceptivo de barrera o practicar la abstinencia.
    E.4Principal exclusion criteria
    1. Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma;
    2. Bulky disease (Lugano 2014 definition: single or conglomerated nodal mass with the largest diameter measuring 10 or more centimeters).
    3. B symptoms
    4. Extra nodal site involved by disease
    5. Female patients who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug;
    6. Uncompensated diabetes mellitus requiring insulin therapy;
    7. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol
    8. Known human immunodeficiency virus (HIV) infection with a positive search for HIV antigens by immunoblot and/or circulating copies of HIV-RNA;
    9. Active hepatitis B with circulating copies of HBV-DNA, or active hepatitis C infection with circulating copies of HCV-RNA;
    10. Severely impaired, lung and renal function;
    11. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection;
    12. Active autoimmune disorder in treatment with immunosuppressive drugs
    13. A left-ventricular ejection fraction < 50%;
    14. Myocardial infarction within 2 years of study entry.
    15. Pregnancy or lactation
    1. Linfoma de Hodgkin mixto o linfoma de Hodgkin con predominio linfocitario nodular;
    2. Neoplasia maligna con gran masa tumoral (de acuerdo con la definición de Lugano 2014: una masa ganglionar única o conglomerada con un diámetro mayor de al menos 10 centímetros).
    3. Síntomas B
    4. Afectación con la enfermedad en localizaciones extraganglionares
    5. Pacientes que estén en período de lactancia o hayan presentado un resultado positivo en una prueba de embarazo en suero realizada durante el período de selección, o en una prueba
    de embarazo que se haya realizado el día 1, antes de la administración de la primera dosis del fármaco del estudio;
    6. Diabetes mellitus descompensada que requiera insulinoterapia;
    7. Presentar cualquier enfermedad grave (incluidos los trastornos psiquiátricos) que, en opinión del investigador, podría interferir con el cumplimiento terapéutico del paciente, de acuerdo
    con este protocolo.
    8. Presencia de infección por el virus de la inmunodeficiencia humana (VIH), con un resultado positivo en la prueba de antígenos (inmunotransferencia) para el VIH y/o copias circulantes
    del ARN del VIH;
    9. Presencia de infección activa por hepatitis B con copias circulantes de ADN del VHB, o infección activa por hepatitis C con copias circulantes de ADN del VHC;
    10. Función pulmonar y renal gravemente deterioradas;
    11. Haber sido diagnosticado o haber recibido tratamiento para otra neoplasia maligna en el transcurso de los 3 años previos a la primera dosis, o haber sido diagnosticado previamente
    con otra neoplasia maligna y presentar indicios de enfermedad residual. No se excluirá a los pacientes con cáncer de piel no melanomatoso o carcinoma in situ de cualquier tipo, siempre
    que se hayan sometido a una resección completa.
    12. Presencia de trastorno autoinmunitario activo en tratamiento con medicamentos inmunodepresores
    13. Fracción de eyección del ventrículo izquierdo <50 %;
    14. Infarto de miocardio en el transcurso de los 2 años anteriores a la inclusión en el estudio.
    15. Pacientes embarazadas o en período de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the overall efficacy in terms of 3-Y PFS, defined as the time from registration until first occurrence of disease progression or relapse, or death for any reason of chemotherapy alone in non-bulky stage I-IIA Hodgkin Lymphoma (eHL), patients with a very low risk of treatment failure, as defined by a low Metabolic Tumor Volume (MTV) and a negative interim PET after 2 ABVD cycle (PET-2).
    Evaluar la eficacia global del tratamiento quimioterápico en monoterapia desde el punto de vista de la SSG al cabo de 3 años, definida como el período transcurrido desde el registro del paciente hasta la primera ocasión en la que se produzca progresión o recidiva de la enfermedad o la muerte por cualquier causa, en pacientes con linfoma de Hodgkin (LHei) en estadios I-IIA y sin gran masa tumoral, que presenten riesgo bajo de fracaso del tratamiento, esto es, que presenten un volumen metabólico tumoral (VMT) bajo y un resultado negativo en una PET intermedia después de 2 ciclos de ABVD (PET-2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During follow-up after the end of treatment
    Durante el seguimiento al final del tratamiento
    E.5.2Secondary end point(s)
    1. To explore the efficacy in terms of 3-Y PFS defined as the time from registration until first occurrence of disease progression or relapse, or death for any reason of CMT plus Nivolumab in high-risk eHL, defined either by a positive PET-2 or a high baseline MTV or both.
    2. To evaluate the efficacy, in terms of three-year freedom from second treatment Failure (3-Y FF2TF), measured from the date of registration to the date of second relapse after radiotherapy “on demand” to rescue patients relapsed after CT alone with the pattern of “limited relapse”, followed by Nivolumab maintenance.
    3. To evaluate the safety, in terms of 3-Y OS, defined as the time from randomization until death for any reason of radiotherapy “on demand” in rescuing patients relapsed after CT alone with the pattern of “limited relapse”, followed by Nivolumab maintenance.
    4. Overall accuracy, sensitivity, specificity, negative predictive value and positive predictive value of cell-free DNA to detect an impending relapse during follow-up of patients treated with chemotherapy alone
    1. Evaluar la eficacia de CMT y nivolumab desde el punto de vista de la SSP al cabo de 3 años, definida como el período transcurrido desde el registro del paciente hasta la primera ocasión en la que se produzca progresión o recidiva de la enfermedad o la muerte por cualquier causa, en pacientes con LHei de riesgo alto, esto es, que presenten un resultado positivo en la PET-2 o que inicialmente presenten un volumen metabólico tumoral (VMT) alto, o ambos.
    2. Evaluar la eficacia desde el punto de vista de la ausencia de un segundo fracaso del tratamiento al cabo de 3 años (A2FT3A), definida como el período comprendido entre la fecha de registro y la fecha de la segunda recidiva tras la administración de radioterapia a demanda como tratamiento de rescate tras la recidiva después de un tratamiento quimioterápico en monoterapia en pacientes con patrón de "recidiva limitada", seguida de un tratamiento de mantenimiento con nivolumab.
    3. Evaluar la seguridad desde el punto de vista de la SG al cabo de 3 años, definida como el período comprendido entre la aleatorización hasta la muerte por cualquier causa, de la radioterapia a demanda como tratamiento de rescate en pacientes con patrón de "recidiva limitada" que hayan sufrido recidiva de la enfermedad tras la administración de un tratamiento quimioterápico en monoterapia, seguida de un tratamiento de mantenimiento con nivolumab.
    4. Exactitud, sensibilidad, especificidad, valor predictivo negativo y valor predictivo positivo globales del ADN sin células para detectar una recaída inminente durante el seguimiento en pacientes tratados exclusivamente con quimioterapia
    E.5.2.1Timepoint(s) of evaluation of this end point
    During follow-up after the end of treatment
    Durante el seguimiento al final del tratamiento
    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 Yes
    E.6.13.1Other scope of the trial description
    relapse biomarker
    recaída en biomarcadores
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    LSLV
    Útlima visita del último paciente
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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: 160
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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)
    None
    Ninguno
    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 Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-21
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 18 06:21:46 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA