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    Summary
    EudraCT Number:2021-004864-81
    Sponsor's Protocol Code Number:ORION
    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:2021-09-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-004864-81
    A.3Full title of the trial
    Proposta di studio per valutare l’efficacia di Obinutuzumab, un anticorpo anti-CD20, in pazienti con nefropatia membranosa intolleranti, resistenti o dipendenti alla terapia con Rituximab (studio ORION)
    OBINUTUZUMAB FOR PRIMARY MEMBRANOUS NEPHROPATHY: A PILOT STUDY IN PATIENTS WITH RITUXIMAB-RESISTANT OR RITUXIMAB-DEPENDENT NEPHROTIC SYNDROME AND IN PATIENTS INTOLERANT TO RITUXIMAB
    (THE ORION STUDY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proposta di studio per valutare l’efficacia di Obinutuzumab, un anticorpo anti-CD20, in pazienti con nefropatia membranosa intolleranti, resistenti o dipendenti alla terapia con Rituximab (studio ORION)
    OBINUTUZUMAB FOR PRIMARY MEMBRANOUS NEPHROPATHY: A PILOT STUDY IN PATIENTS WITH RITUXIMAB-RESISTANT OR RITUXIMAB-DEPENDENT NEPHROTIC SYNDROME AND IN PATIENTS INTOLERANT TO RITUXIMAB
    (THE ORION STUDY)
    A.3.2Name or abbreviated title of the trial where available
    Obinutuzumab in primary MN
    Obinutuzumab nella Nefropatia Membranosa primaria
    A.4.1Sponsor's protocol code numberORION
    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 SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRoche
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportIRCCS Istituto Mario Negri
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche Mario Negri
    B.5.2Functional name of contact pointLab. Attività Regolatorie
    B.5.3 Address:
    B.5.3.1Street Addressvia G.B. Camozzi 3
    B.5.3.2Town/ cityRanica
    B.5.3.3Post code24020
    B.5.3.4CountryItaly
    B.5.4Telephone number034535307
    B.5.5Fax number0354535371
    B.5.6E-mailpaola.boccardo@marionegri.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name GAZYVARO - 1000 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 1000MG/40ML - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGAZYVARO
    D.3.2Product code [L01XC15]
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNObitunuzumab
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRO5072759
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 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.IMP: 2
    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 OMNIPAQUE - 300 MG I/ML SOLUZIONE INIETTABILE FLACONE IN POLIPROPILENE DA 50 ML
    D.2.1.1.2Name of the Marketing Authorisation holderGE HEALTHCARE S.R.L.
    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 nameOMNIPAQUE
    D.3.2Product code [Ioexolo]
    D.3.4Pharmaceutical form Solution for injection
    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 INNioexolo
    D.3.9.1CAS number 66108-95-0
    D.3.9.2Current sponsor codeioexolo
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3235
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 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
    PRIMARY MEMBRANOUS NEPHROPATHY
    Nefropatia membranosa primaria
    E.1.1.1Medical condition in easily understood language
    PRIMARY MEMBRANOUS NEPHROPATHY
    Nefropatia membranosa primaria
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10027170
    E.1.2Term Membranous nephropathy
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether rescue therapy with Obinutuzumab may induce remission of MN-related nephrotic syndrome in (1) Rituximab-Intolerant patients and in (2) Rituximab-Resistant or Rituximab-Dependent patients, and whether this drug is safe and well tolerated in these cohorts.
    Valutare se la terapia con obinutuzumab può indurre la remissione della sindrome nefrosica in (1) pazienti intolleranti al Rituximab e in (2) pazienti resistenti o dipendenti al Rituximab e se il farmaco è sicuro e ben tollerato in queste coorti di pazienti.
    E.2.2Secondary objectives of the trial
    To assess, in patients who are treated with Obinutuzumab:
    - Levels of proteinuria and urinary markers of glomerular selectivity over time.
    - Renal function parameters over time.
    - Circulating leukocyte subsets over time.
    - Immunologic disease activity in the subset of patients with detectable anti-PLA2R antibodies
    - Patient health-related quality of life
    Determinare, nei pazienti trattati con obinutuzumab:
    - Valori di proteinuria e marker urinari di selettività glomerulare nel tempo.
    - Parametri di funzione renale nel tempo.
    - Sottopopolazioni di leucociti circolanti.
    - Attività della malattia immunologica nel gruppo di pazienti con anticorpi anti-PLA2R
    - Qualità della vita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults (=18 years old) on the day of signing informed consent.
    2. Primary membranous nephropathy.
    3. Availability of a recent (over the last month) diagnostic kidney biopsy to confirm the diagnosis of membranous nephropathy and quantify the severity of chronic changes and the number of glomerular podocytes.
    4. High-risk of progression to end-stage kidney disease due to persistent nephrotic-range proteinuria (urinary protein excretion > 3.5 g/24-hours as a median of three consecutive measurements) despite background treatment with RAS-inhibitors (ACEi and/or ARBs) at the maximum tolerated doses for at least six months before inclusion.
    5. Failure to definitively and effectively respond to rituximab therapy because of the following:
    a) RITUXIMAB-INTOLERANCE, i.e. any previous severe hypersensitivity reaction to rituximab (acute grade III or IV adverse reactions requiring advanced care, or late reactions including delayed serum sickness syndrome) that, independent of response to treatment, preclude further exposure to the drug;
    or
    b) RITUXIMAB-RESISTANCE: no evidence of nephrotic syndrome complete remission (24-hour proteinuria < 0.3 g/day, normal serum albumin and stable renal function) or partial remission (24-hour proteinuria < 3.5 g/day with > 50% decrease from baseline, normal serum albumin and stable renal function) for at least 12 months after rituximab administration;
    or
    c) RITUXIMAB-DEPENDENCE:frequently-relapsing nephrotic syndrome (= 2 relapses) with nephrotic-range proteinuria for = 50% of time in the 24 months preceding enrolment
    6. Estimated GFR/eGFR) =40 mL/min/1.73m2 (calculated using the CKD-EPI equation) or qualified endogenous creatinine clearance =40 mL/min based on 24-hour urine collection during screening.
    7. Ability to understand and provide a valid written consent to the study according to the guidelines of the Declaration of Helsinki.
    8. Compliance with an effective contraception without interruption, from 28 days before treatment start up to 18 months after treatment discontinuation, agreeing not to donate semen during treatment and for 18 months after discontinuation (if the patient is male), or to undergo pregnancy test during the course of the study (if the patient is female).
    1. Donne e uomini con età =18 anni alla firma del consenso.
    2. Nefropatia membranosa primaria.
    3. Disponibilità di una biopsia renale recente (nell’ultimo mese) che confermi la diagnosi e quantifichi la severità dei cambiamenti cronici e il numero dei podociti glomerulari.
    4. Alto rischio di progressione verso l’insufficienza renale terminale dovuto ad una proteinuria in range nefrosico (escrezione di proteine nelle urine > 3.5 g/24-ore valutata come mediana di tre misurazioni consecutive) nonostante la terapia con inibitori del RAS (ACEi e/o ARBs) alla massima dose tollerata nei sei mesi precedenti l’inclusione nello studio.
    5. Mancata risposta alla terapia con rituximab per uno dei seguenti motivi:
    - INTOLLERANZA AL RITUXIMAB, pazienti intolleranti al rituximab, che abbiano avuto reazioni allergiche che ne precludono l’impiego futuro, indipendentemente dalla risposta al trattamento;
    o
    - RESISTENZA AL RITUXIMAB, pazienti resistenti al rituximab, che non hanno risposto alla terapia né con una remissione completa (definita come proteinuria delle 24 ore < 0.3 g/die, livelli di albumina sierica nel range di normalità e funzione renale stabile) né parziale (definita come proteinuria delle 24 0re < 3.5 g/die con una diminuzione > 50% rispetto al basale, livelli di albumina sierica nel range di normalità e funzione renale stabile) della sindrome nefrosica, per almeno 12 mesi dalla prima somministrazione di rituximab;
    o
    - DIPENDENZA DA RITUXIMAB, pazienti dipendenti da rituximab, con frequenti recidive di sindrome nefrosica (= 2 recidive), in presenza di proteinuria nel range nefrosico, per un tempo almeno almeno = 50% nei 24 mesi che precedono l’inizio dello studio
    6. GFR/eGFR stimato =40 mL/min/1.73m2 calcolato usando l’equazione di CKD-EPI o con la clearance della creatinina sulla raccolta urinaria delle 24 ore durante il periodo di screening.
    7. Capacità di comprendere lo studio e di fornire un consenso informato scritto in accordo con la Dichiarazione di Helsinki.
    8. Adozione di un metodo contraccettivo efficace, senza interruzioni, 28 giorni prima dell’inizio del trattamento fino a 18 mesi dopo l’interruzione dello stesso; disponibilità a non donare il seme durante il trattamento e per i 18 mesi successive, in caso di un paziente di sesso maschile, e a non programmare una gravidanza, nel caso di un a paziente di sesso femminile.
    E.4Principal exclusion criteria
    1. Secondary forms of membranous nephropathy (associated with systemic lupus erythematosus, active hepatitis B, malignancy, drugs such as gold salts and penicillamine, and others).
    2. Rituximab treatment or any other prolonged (i.e. for more than two weeks) immunosuppressive treatment in the 12 months preceding anti-CD20 infusion.
    3. Uncontrolled hypertension (systolic BP =160 and/or diastolic BP >90 mmHg despite therapy).
    4. Active bacterial, viral and/or fungal infections.
    5. Seropositivity for HIV, regardless of viral load.
    6. Active or recent (< 5 years before enrolment) history of malignancy.
    7. Known hypersensitivity or allergy to any of the medicaments under investigation.
    8. Any other serious medical condition, uncontrolled intercurrent illness or laboratory abnormality that, according to the investigator’s judgement, would constitute an unacceptable risk of premature discontinuation from the study.
    9. Known history of drug induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension.
    10. Pregnancy or breast-feeding
    11. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method.
    12. Legal incapacity, limited legal capacity, intellectual disability, uncooperative attitude or any other evidence that the patient will not be able to understand the study aims and procedures.
    1. Forme di NM secondarie (ad esempio associate a lupus eritematoso sistemico, epatite B attiva, tumori, farmaci come Sali d’oro o penicillina).
    2. Trattamento con rituximab treatment o qualsiasi trattamento immunosoppressivo prolungato (ad esempio per più di due settimane) nei 12 mesi che precedono l’infusione con anticorpi anti-CD20.
    3. Ipertensione non controllata (sistolica =160 e/o diastolica BP >90 mmHg nonostante la terapia).
    4. Infezioni batteriche, virali e/o fungine attive.
    5. Sieropositività per HIV, indipendentemente dalla carica virale.
    6. Tumore maligno attivo o verificatosi nei 5 anni precedenti l’inizio dello studio.
    7. Ipersensibilità o allergia note ai farmaci in sperimentazione.
    8. Qualsiasi patologia grave, malattia intercorrente non controllata o anomalia negli esami di laboratorio che, a giudizio dello sperimentatore, potrebbero portare ad un rischio inaccettabile che il paziente debba interrompere prematuramente lo studio.
    9. Storia nota di danno epatico indotto da farmaci, da abuso di alcolici, steatoepatite, cirrosi biliare primaria, ostruzione extraepatica causata da colelitiasi, cirrosi epatica o ipertensione portale. Gravidanza o allattamento.
    10. Soggetti potenzialmente fertili e riluttanza o impossibilità ad adottare un metodo scientificamente valido di controllo delle nascite.
    11. Incapacità legale, capacità legale limitata, disabilità intellettiva, mancanza di attitudine a cooperare o qualsiasi altra evidenza che il paziente non sia in grado di comprenedere gli obiettivi e le procedure dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    1) Incidence of complete or partial remission of nephrotic syndrome at 12 months from Obinutuzumab treatment in (1) Rituximab-Intolerant patients and (2) Rituximab-Resistant and Rituximab-Dependent patients considered separately and as a whole.

    2) Incidence of serious and non-serious adverse events (in particular, infusion-related reactions (IRRs)) during and after Obinutuzumab treatment in (1) Rituximab-Intolerant patients and (2) Rituximab-Resistant and Rituximab-Dependent patients considered separately and as a whole.
    1) Incidenza di completa o parziale remissione della sindrome nefrosica 12 mesi dopo il trattamento con obinutuzumab in (1) pazienti intolleranti al rituximab e (2) pazienti resistenti al e dipendenti da rituximab considerati separatamente o come unico gruppo.

    2) Incidenza di eventi avversi seri e non seri (in particolare, reazioni legate all’infusione (IRR)) durante e dopo il trattamento con obinutuzumab in (1) pazienti intolleranti al rituximab e (2) pazienti resistenti e dipendenti da rituximab considerati separatamente o come unico gruppo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) At 12 months from Obinutuzumab treatment.

    2) During and after Obinutuzumab treatment.
    1) 12 mesi dalla somministrazione del trattamento.

    2) Durante e dopo il trattamento con obinutuzumab.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After a subject has ended his/her participation in the trial he/she will be treated with
    the best therapy available.
    Al termine della loro partecipazione allo studio i pazienti saranno trattati con la migliore terapia disponibile.
    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 Decision2021-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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