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    Summary
    EudraCT Number:2020-000142-34
    Sponsor's Protocol Code Number:ITCC-092/IST11028
    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:2021-06-08
    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 number2020-000142-34
    A.3Full title of the trial
    A Phase Ib study of Vyxeos® (liposomal daunorubicin and cytarabine) in combination with Clofarabine in children with relapsed/refractory AML, ITCC-092
    Studio di fase Ib con Vyxeos® (daunorubicina liposomiale e citarabina) in combinazione con clofarabina in bambini affetti da LMA recidivata /refrattaria, ITCC-092
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vyxeos® and Clofarabine in children with a specific type of blood cancer (AML) that has returned or is persistent
    Vyxeos® e clofarabina in bambini con un tipo specifico di cancro del sangue (LMA) che è tornato o è persistente
    A.3.2Name or abbreviated title of the trial where available
    Vyxeos® and Clofarabine in relapsed/refractory pediatric AML
    Vyxeos® e clofarabina nelle AML pediatriche recidivate/regrattarie
    A.4.1Sponsor's protocol code numberITCC-092/IST11028
    A.5.4Other Identifiers
    Name:Nederlands Trialregister (NTR)Number:NL8134
    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 SponsorPrinses Maxima Centrum voor kinderoncologie
    B.1.3.4CountryNetherlands
    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 supportPrincess Máxima Center for pediatric oncology
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione MBBM
    B.5.2Functional name of contact pointUnità di Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Pergolesi, 33
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number0392333525
    B.5.5Fax number0392336827
    B.5.6E-mailsperimentazioneclinica@fondazionembbm.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 Vyxeos liposomal
    D.2.1.1.2Name of the Marketing Authorisation holderJazz Pharmaceuticals Ireland Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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/3/11/942
    D.3 Description of the IMP
    D.3.1Product nameVyxeos liposomial
    D.3.2Product code [CPX-351]
    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 INNCITARABINA
    D.3.9.1CAS number 147-94-4
    D.3.9.2Current sponsor codeCYTARABINE
    D.3.9.3Other descriptive nameANTINEOPLASTICO
    D.3.9.4EV Substance CodeSUB06880MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDAUNORUBICINA
    D.3.9.1CAS number 20830-81-3
    D.3.9.2Current sponsor codeDAUNORUBICIN
    D.3.9.3Other descriptive nameANTINEOPLASTIC
    D.3.9.4EV Substance CodeSUB06917MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2
    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.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 Evoltra
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameCLOFARABINA
    D.3.2Product code [CLOFARABINA]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNCLOFARABINA
    D.3.9.1CAS number 123318-82-1
    D.3.9.2Current sponsor codeCLOFARABINA
    D.3.9.3Other descriptive nameCLOFARABIN
    D.3.9.4EV Substance CodeSUB21902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Relapsed or refractory pediatric acute myeloid leukemia
    Leucemia mieloide acuta pediatrica refrattaria o recidivata
    E.1.1.1Medical condition in easily understood language
    Returning or treatment-resistant acute cancer of the myeloid line of blood cells in children
    Leucemia mieloide acuta pediatrica che non risponde alle terapie convenzionali o che si è ripresentata
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML
    Stabilire la dose raccomandata per la fase 2 di Vyxeos® / CPX-351 in combinazione con clofarabina nei bambini con LMA recidivante / refrattaria
    E.2.2Secondary objectives of the trial
    • To determine the safety and tolerability of this combination.
    • To determine the (preliminary) efficacy in terms of the hematological remission rate in these patients as determined by morphology with flow cytometric confirmation.
    • To describe the durability of response, including the number of patients that undergo stem- cell transplant after re-induction with this regimen
    • Determinare la sicurezza e la tollerabilità di questa combinazione.
    • Determinare l'efficacia (preliminare) in termini di tasso di remissione ematologica in questi pazienti determinato dalla morfologia con conferma citometrica a flusso.
    • Descrivere la durata della risposta, incluso il numero di pazienti che si sottopongono a trapianto di cellule staminali dopo la reinduzione con questo regime
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age =1 year and <21 years
    • Any = 2nd relapse of AML
    • Refractory AML (defined as = 20% blasts in the bone marrow after standard induction therapy)
    • Early 1st relapse (defined as relapse within one year from initial diagnosis) of AML

    • Complete initial work-up within 7 days prior to study entry, including bone-marrow aspiration, lumbar puncture (without intrathecal therapy)
    • Lansky play score = 60 for patients <16 years of age; or Karnofsky performance status = 60 for patients = 16 years of age (see Appendix I for Performance scales).
    • Life expectancy > 6 weeks
    • The patient must have a calculated GFR = 70mL/min/1.73 m2.
    • Liver function: total serum bilirubin = 3 mg/dl or 50 µmol/L and aspartate transaminase (AST) and alanine transaminase (ALT) =200 U/L
    • Adequate cardiac function (defined as shortening fraction =28% or ejection fraction =50%)

    • For female patients with childbearing potential, a negative test for pregnancy is to be performed before entry on study.
    • Male and female patients must use a highly effective contraceptive method during the study and for a minimum of 6 months after study treatment.
    • Female patients may not breastfeed during the study and for a minimum of 3 months after study treatment.
    • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule is required; those conditions should be discussed with the patient before registration in the trial.
    • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

    Concomitant treatments:
    • Concomitant administration of any other experimental drug under investigation, or concurrent treatment with any other anti-cancer therapy other than specified in the protocol is not allowed.
    • GCSF will not be used for priming and no routine GCSF support is allowed during the 1st course, except for life-threatening infections.

    Additional criteria:
    • At least 6 patients must be enrolled with an M3 or a WBC count >10x109/L with blasts
    • Età = 1 anno e =21 anni
    • seconda recidiva AML
    • LMA refrattaria (definita come = 20% di blasti nel midollo osseo dopo terapia di induzione)
    • Prima recidiva precoce (definita come ricaduta entro un anno dalla diagnosi iniziale) di AML

    • Completare il work-up iniziale entro 7 giorni prima dell'ingresso nello studio, incluso l'aspirato midollare, puntura lombare (senza terapia intratecale)
    • Lansky score 60 per pazienti <16 anni; Karnofsky performance status 60 per pazienti amggiori di 16 anni (vedi Appendix I per Performance scales)
    • aspettativa di vita maggiore di 6 mesi
    • pazienti con GFR = 70mL/min/1.73 m2
    • funzione epatica: bilirubina sierica =3 mg/dl or 50 µmol/L, aspartato aminotransferasi (AST) e alanina aminotransferasi (ALT) =200 U/L
    • adeguata funzione cardiaca( definita come frazione di accorciamento =28% o frazione di eiezione =50%)

    • Per le pazienti di sesso femminile potenzialmente fertili, prima dell'ingresso nello studio deve essere eseguito un test di gravidanza negativo.
    • I pazienti di sesso maschile e femminile devono utilizzare un metodo contraccettivo altamente efficace durante lo studio e per un minimo di 6 mesi dopo il trattamento
    • Le pazienti di sesso femminile non possono allattare al seno durante lo studio e per un minimo di 3 mesi dopo il trattamento in studio.
    • È richiesta l'assenza di qualsiasi condizione psicologica, familiare, sociologica o geografica che possa ostacolare il rispetto del protocollo di studio e del programma di follow-up; tali condizioni dovrebbero essere discusse con il paziente prima della registrazione nello studio.
    • Prima della registrazione del paziente, deve essere fornito il consenso informato scritto secondo ICH / GCP e le normative nazionali / locali.

    Trattamenti concomitanti:
    • La somministrazione concomitante di qualsiasi altro farmaco sperimentale in esame o il trattamento concomitante con qualsiasi altra terapia anti-cancro diversa da quella specificata nel protocollo non è consentita.
    • GCSF non verrà utilizzato per il priming e non è consentito supporto con GCSF durante il 1 ° ciclo, ad eccezione di infezioni potenzialmente letali.

    Criteri aggiuntivi:
    • Almeno 6 pazienti devono essere arruolati con un M3 o una conta leucocitaria> 10x109 / L con blasti
    E.4Principal exclusion criteria
    • Evidence of a currently uncontrolled bacterial, viral or parasitic infection
    • Evidence of a fungal infection, defined as either:
    - Pulmonary infiltrates suggestive of a fungal infection at HR-CT (within 3 weeks prior to enrollment)
    - Positive Aspergillus serum test (galactomannan), according to local laboratory practice (within 3 weeks prior to enrollment)
    • Evidence of isolated extramedullary relapse, including isolated CNS-relapse
    • Evidence of CNS3 or symptomatic CNS leukemia
    • Down Syndrome
    • Evidence of relapsed/refractory acute promyelocytic leukemia (APL)
    • Use of any anticancer therapy within 2 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy (note: hematological toxicities do not need to be considered since the patient has overt leukemia)
    • History of prior veno-occlusive disease (VOD)
    • Known hypersensitivity to cytarabine, clofarabine or liposomal daunorubicin
    • Known copper metabolism deficiency, such as Wilson's disease
    • Evidenza di infezione batterica, virale o parassitaria attualmente incontrollata
    • Evidenza di un'infezione fungina, definita come:
    - Infiltrati polmonari suggestivi di un'infezione fungina alla HR-CT (entro 3 settimane prima dell'arruolamento)
    - Test del siero Aspergillus positivo (galattomannano), secondo la pratica di laboratorio locale (entro 3 settimane prima dell'arruolamento)
    • Evidenza di recidiva extramidollare isolata, inclusa recidiva del SNC isolata
    • Evidenza di leucemia CNS3 o sintomatica del SNC
    • Sindrome di Down
    • Evidenza di leucemia promielocitica acuta recidivante / refrattaria (LAP)
    • Uso di qualsiasi terapia antitumorale entro 2 settimane prima dell'ingresso nello studio. Il paziente deve essersi ripreso da tutte le tossicità acute da qualsiasi terapia precedente (nota: non è necessario considerare le tossicità ematologiche poiché il paziente ha leucemia manifesta)
    • Storia di precedente malattia veno-occlusiva (VOD)
    • Nota ipersensibilità a citarabina, clofarabina o daunorubicina liposomiale
    • Nota carenza del metabolismo del rame, come la malattia di Wilson
    E.5 End points
    E.5.1Primary end point(s)
    Dose-limiting toxicities (DLTs) during the first course of therapy.


    Tossicità dose-limitanti (DLT) durante il primo ciclo di terapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT evaluation after course 1
    Valutazione DLT dopo il ciclo 1
    E.5.2Secondary end point(s)
    • safety and tolerability of combination clofarabine with Vyxeos/CPX-351
    • hematological remission rate
    • overall response rate (ORR)
    • number of patients that undergo HSCT

    Exploratory endpoints:
    • serum and intracellular pharmacokinetics parameters of Vyxeos/CPX-351
    • relationship ORR and intracellular Ara-CTP accumulation
    • correlation duration of response and MRD
    • sicurezza e tollerabilità dell'associazione clofarabina con Vyxeos / CPX-351
    • tasso di remissione ematologica
    • tasso di risposta globale (ORR)
    • numero di pazienti sottoposti a HSCT

    Endpoint esplorativi:
    • parametri di farmacocinetica sierica e intracellulare di Vyxeos / CPX-351
    • relazione ORR e accumulo intracellulare di Ara-CTP
    • correlazione durata della risposta e MRD
    E.5.2.1Timepoint(s) of evaluation of this end point
    • After course 1, after each subsequent course of therapy, and at 4wks, 10wks, 3months, 6 months and 9 months, 12 months, 18 months and 24 months of FUP
    • end of study (EOS)
    • Dopo il corso 1, dopo ogni ciclo successivo di terapia e dopo 4 settimane, 10 settimane, 3 mesi, 6 mesi e 9 mesi, 12 mesi, 18 mesi e 24 mesi di FUP
    • fine studio (EOS)
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration of combination clofarabine with Vyxeos/CPX-351 in pediatric population
    Prima somministrazione di clofarabina combinata con Vyxeos / CPX-351 nella popolazione pediatrica
    E.7.2Therapeutic exploratory (Phase II) No
    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 Yes
    E.8.2.3.1Comparator description
    terapia di combinazione Vyxeos / CPX-351 con clofarabina
    combination therapy Vyxeos/CPX-351 with clofarabine
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 years4
    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 years4
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 3
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 9
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 13
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children
    Minori
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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
    nessuno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ITCC
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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