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    Summary
    EudraCT Number:2021-000621-27
    Sponsor's Protocol Code Number:RTRX-RE021-201
    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:2021-10-12
    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 number2021-000621-27
    A.3Full title of the trial
    A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).
    Studio di coorte di fase 2, in aperto, a braccio singolo per valutare la sicurezza, l’efficacia e la farmacocinetica del trattamento con sparsentan in soggetti pediatrici affetti da malattie glomerulari proteinuriche selezionate (EPPIK)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.
    Sicurezza, efficacia e farmacocinetica di sparsentan in soggetti pediatrici
    affetti da malattie renali selezionate.
    A.3.2Name or abbreviated title of the trial where available
    EPPIK
    EPPIK
    A.4.1Sponsor's protocol code numberRTRX-RE021-201
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/021/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTRAVERE THERAPEUTICS, 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 supportTravere Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTravere Therapeutics, Inc.
    B.5.2Functional name of contact pointTravere Therapeutics Call Center
    B.5.3 Address:
    B.5.3.1Street Address3611 Valley Centre Drive, Suite 300
    B.5.3.2Town/ citySan Diego, California
    B.5.3.3Post code92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018776595518
    B.5.6E-mailmedinfo@travere.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 No
    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/3/15/1574 - FSGS EU/3/20/2345 - IGAN
    D.3 Description of the IMP
    D.3.1Product nameSparsentan
    D.3.2Product code [RE-021]
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSparsentan
    D.3.9.1CAS number 254740-64-2
    D.3.9.2Current sponsor codeRE-021
    D.3.9.4EV Substance CodeSUB168607
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Proteinuric glomerular diseases including:

    •Focal segmental glomerulosclerosis (FSGS)
    •Minimal change disease (MCD)
    •Immunoglobulin A nephropathy (IgAN)
    •Immunoglobulin A vasculitis (IgAV)
    •Alport syndrome (AS)
    Malattie glomerulari proteinuriche incluso:

    -glomerulosclerosi focale segmentale (GSFS)
    -malattia a lesioni minime (MCD)
    -nefropatia da immunoglobulina A (IgAN),
    -vasculite da immunoglobulina A (IgAV)
    -sindrome di Alport (SA)
    E.1.1.1Medical condition in easily understood language
    Diseases of the filtering unit of the kidney (glomerulus).
    Malattie delle sezioni filtranti dei reni
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067757
    E.1.2Term Focal segmental glomerulosclerosis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021263
    E.1.2Term IgA nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10082959
    E.1.2Term IgA vasculitis
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001843
    E.1.2Term Alport's syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10058326
    E.1.2Term Minimal change disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objects of the study are as follows:
    • Evaluate the safety and tolerability of sparsentan oral suspension
    • Assess changes in proteinuria after once-daily dosing of sparsentan oral suspension over the 108-week treatment period
    Gli obiettivi primari sono i seguenti:
    • Valutare la sicurezza e la tollerabilità di sparsentan in sospensione orale
    • Valutare le variazioni della proteinuria dopo la somministrazione una volta al giorno di sparsentan in sospensione orale nel periodo di trattamento di 108 settimane
    E.2.2Secondary objectives of the trial
    The secondary objectives are as follows:
    • Assess the PK of sparsentan oral suspension in a pediatric population
    • Assess changes in estimated eGFR after once-daily dosing of sparsentan oral suspension over the 108-week treatment period
    Gli obiettivi secondari sono i seguenti:
    • Valutare la farmacocinetica (PK) di sparsentan in sospensione orale in una popolazione pediatrica
    • Valutare le variazioni della velocità di filtrazione glomerulare stimata (eGFR) dopo la somministrazione una volta al giorno di sparsentan in sospensione orale nel periodo di trattamento di 108 settimane
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For All Subjects (Both Populations)
    A subject must meet all of the following criteria to be eligible for participation in this study:
    1. The subject or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent, and where required, the subject is willing to provide assent before any screening procedures per local requirements.
    2. The subject has an eGFR =30 mL/min/1.73 m2 at screening.
    3. The subject has a mean seated blood pressure between the 5th and 95th percentile for age, sex, and height.

    For Population 1
    1. The subject is male or female =1 year at screening to <18 years of age at Day 1.
    2. The subject has a UP/C =1.5 g/g at screening AND one of the following:
    • Biopsy-proven FSGS or MCD histological patterns and clinical presentation consistent with primary FSGS or MCD and qualifying proteinuria at screening despite history or ongoing treatment with corticosteroids and/or other immunosuppressive disease-modifying agents.
    • Documentation of a genetic mutation in a podocyte protein associated with FSGS or MCD. Subjects with a documented podocytic mutation do not require kidney biopsy.
    • Biopsy-proven FSGS histological pattern with medical history and clinical presentation consistent with maladaptive cause of the lesion.

    For Population 2
    1. The subject is male or female =2 years to <18 years of age at screening.
    2. The subject has UP/C =1.0 g/g at screening AND one of the following:
    • Biopsy-confirmed IgAN or IgAV
    • AS (pathogenic X-linked COL4A5 mutation OR autosomal-recessive mutations in both alleles of COL4A3 and/or COL4A4 OR autosomal-dominant COL4A3 and/or COL4A4 and digenic mutations [ie, simultaneous mutations in 2 of the COL4A3, COL4A4, and COL4A5 genes])
    Criteri di inclusione per tutti i soggetti (entrambe le popolazioni):
    Per risultare idonei a partecipare a questo studio, il soggetto deve soddisfare tutti i seguenti criteri:
    1. il soggetto o il genitore/tutore legale (a seconda dei casi) è disposto e in grado di fornire il consenso informato firmato e, ove richiesto, il soggetto è disposto a fornire l’assenso prima di qualsiasi procedura di screening secondo i requisiti locali.
    2. il soggetto presenta una eGFR =30 ml/min/1,73 m2 al momento dello screening.
    3. il soggetto presenta una pressione arteriosa media rilevata in posizione seduta compresa tra il 5° e il 95° percentile a seconda dell’età, del sesso e dell’altezza.
    Criteri di inclusione per la popolazione 1:
    1. il soggetto è di sesso maschile o femminile, di età compresa tra = 1 anno al momento dello screening e < 18 anni al Giorno 1.
    2. il soggetto presenta un UPC = 1,5 g/g al momento dello screening E uno dei seguenti:
    • quadro istologico di GSFS o MCD confermato da biopsia e presentazione clinica coerenti con GSFS o MCD primarie e presenza di proteinuria necessaria per qualificarsi al momento dello screening nonostante l’anamnesi o il trattamento in corso con corticosteroidi e/o altri agenti immunosoppressori modificanti la malattia.
    • documentazione di una mutazione genetica in una proteina del podocita associata a GSFS o MCD. I soggetti con una mutazione del podocita documentata non necessitano di biopsia renale.
    • quadro istologico di GSFS confermato da biopsia con anamnesi medica e presentazione clinica coerenti con una lesione causata da disequilibrio tra carico e capacità di adattamento glomerulare.

    Criteri di inclusione per la popolazione 2:
    1. il soggetto è di sesso maschile o femminile, di età compresa tra = 2 anni e < 18 anni al momento dello screening.
    2. il soggetto presenta un UPC = 1,0 g/g al momento dello screening E una delle seguenti diagnosi:
    • IgAN o IgAV confermate da biopsia
    • SA (mutazione patogena di COL4A5 legata al cromosoma X OPPURE mutazioni autosomiche recessive in entrambi gli alleli di COL4A3 e/o COL4A4 OPPURE mutazioni autosomiche dominanti di COL4A3 e/o COL4A4 e mutazioni digeniche [ovvero, mutazioni simultanee in 2 dei geni COL4A3, COL4A4 e COL4A5])
    E.4Principal exclusion criteria
    For All Subjects (Both Populations)
    A subject who meets any of the following criteria will be excluded from this study:
    1. The subject weighs <7.3 kg at screening.
    2. The subject has FSGS or MCD histological pattern secondary to viral infections, drug toxicities, or malignancies.
    3. The subject has immunoglobulin A (IgA) glomerular deposits not in the context of primary IgAN or IgAV (ie, secondary to another condition; eg, systemic lupus erythematosus and liver cirrhosis).
    4. The subject has had an acute onset or presentation of glomerular disease or a diagnostic biopsy or a relapse of glomerular disease requiring new or different class of immunosuppressive treatment (including, but not limited to, systemic corticosteroids, calcineurin inhibitors and mycophenolate mofetil abatacept, cyclophosphamide, rituximab, ofatumumab, and ocrelizumab) within 6 months before screening.
    5. Subjects taking chronic immunosuppressive medications (including systemic steroids) not on a stable dose for =1 month before screening.
    6. The subject requires any of the prohibited concomitant medications as defined in the study protocol.
    7. The subject has undergone any organ transplantation, with the exception of corneal transplants.
    8. The subject has a documented history of congenital or acquired heart failure (modified Ross heart failure classification for children Class II to Class IV [Ross 2012]) and/or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema.
    9. The subject has hemodynamically significant cardiac valvular disease.
    10. The subject has clinically significant congenital vascular disease.
    11. The subject has jaundice, hepatitis, or known hepatobiliary disease, or alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of the normal range at screening.
    12. The subject has a history of malignancy within the past 2 years.
    13. The subject has a screening hematocrit <27% or a hemoglobin value <9 g/dL.
    14. The subject has a screening potassium value >5.5 mEq/L.
    15. The subject has any abnormal clinical laboratory screening values that are considered by the Investigator to be clinically significant.
    16. The subject has a history of allergic response to any Ang II antagonist or ERA, including sparsentan, or has a hypersensitivity to any of the excipients in the investigational product.
    ....for the other criteria, please see the protocol
    Criteri di esclusione per tutti i soggetti (entrambe le popolazioni):
    Il soggetto che soddisfa uno qualsiasi dei seguenti criteri sarà escluso da questo studio:
    1. il soggetto pesa < 7,3 kg al momento dello screening.
    2. il soggetto presenta un quadro istologico di GSFS o MCD secondarie a infezioni virali, tossicità farmacologiche o tumore maligno.
    3. il soggetto presenta depositi glomerulari di immunoglobulina A (IgA) non nel contesto di IgAN o di IgAV primaria (ovvero, secondaria a un’altra condizione; per es.: lupus eritematoso sistemico e cirrosi epatica).
    4. il soggetto ha manifestato un’insorgenza acuta o una presentazione di malattia glomerulare o una biopsia diagnostica o una recidiva di malattia glomerulare che richiede una classe di trattamento immunosoppressivo nuova o diversa (inclusi, a titolo esemplificativo ma non esaustivo, corticosteroidi sistemici, inibitori della calcineurina e micofenolato mofetile, abatacept, ciclofosfamide, rituximab, ofatumumab e ocrelizumab) nei 6 mesi precedenti allo screening.
    5. i soggetti sottoposti a trattamenti immunosoppressori cronici (compresi gli steroidi sistemici) non a dose stabile per = 1 mese prima dello screening.
    6. il soggetto necessita di uno qualsiasi dei farmaci concomitanti proibiti, in base a quanto definito nel protocollo dello studio.
    7. il soggetto è stato sottoposto a un qualsiasi trapianto di organo, ad eccezione dei trapianti di cornea.
    8. il soggetto presenta un’anamnesi documentata di insufficienza cardiaca congenita o acquisita (classificazione modificata dell’insufficienza cardiaca nei bambini secondo Ross, da Classe da II a IV) e/o precedente ricovero per insufficienza cardiaca o dispnea inspiegabile, ortopnea, dispnea parossistica notturna, ascite e/o edema periferico.
    9. il soggetto presenta valvulopatia cardiaca emodinamicamente significativa.
    10. il soggetto presenta vasculopatia congenita clinicamente significativa.
    11. il soggetto presenta ittero, epatite, malattia epatobiliare nota oppure livelli di alanina aminotransferasi e/o aspartato aminotransferasi > 2 volte il limite superiore dell’intervallo di normalità al momento dello screening.
    12. il soggetto presenta un’anamnesi di tumore maligno negli ultimi 2 anni.
    13. il soggetto presenta un valore di ematocrito al momento dello screening < 27% o di emoglobina < 9 g/dl.
    14. il soggetto presenta un valore di potassio al momento dello screening > 5,5 mEq/l.
    15. il soggetto presenta valori clinici di laboratorio anomali al momento dello screening ritenuti clinicamente significativi dallo sperimentatore.
    16. il soggetto presenta un’anamnesi di risposta allergica a qualsiasi antagonista dell'angiotensina II o antagonista del recettore dell’endotelina, compreso sparsentan, o presenta un’ipersensibilità a uno qualsiasi degli eccipienti del prodotto sperimentale.
    .....per gli altri criteri si veda il protocollo e/o la Sinossi in italiano
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to treatment discontinuation, and adverse events of interest (AEOIs)
    2. Change from baseline in urine protein/creatinine ratio (UP/C) over the 108-week treatment period
    • Incidenza di eventi avversi emergenti dal trattamento (TEAE), eventi avversi gravi (SAE), eventi avversi (EA) che portano all’interruzione del trattamento ed eventi avversi di interesse
    • Variazione rispetto al basale del rapporto urinario proteine/creatinina (UPC) nel periodo di trattamento di 108 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. During the whole study period
    2. Baseline to all study visits to 108 weeks
    1. Durante tutto il periodo dello studio
    2. Dal Basale a tutte le visite dello studio a 108 settimane
    E.5.2Secondary end point(s)
    1. Observed plasma PK concentrations at scheduled timepoints and visits
    2. Steady-state PK parameters (area under the plasma concentration-time curve during a dosing interval [AUCt], maximum steady-state plasma drug concentration during a dosage interval [Cmax_ss], and minimum steady-state plasma drug concentration [Cmin_ss]) derived from population PK analysis
    3. Change from baseline in urine albumin/creatinine ratio (UA/C) over the 108-week treatment period
    4. Change from baseline in eGFR over the 108-week treatment period
    5. The proportion of subjects with focal segmental glomerulosclerosis (FSGS) and/or minimal change disease (MCD) histological patterns achieving partial remission, defined as UP/C =1.5 g/g and >40% reduction in UP/C over the 108-week treatment period
    1. Concentrazioni plasmatiche farmacocinetiche (PK) del farmaco valutate ai tempi e alle visite programmati
    2. Parametri PK allo stato stazionario (area sottesa alla curva concentrazione plasmatica-tempo [AUCt] durante un intervallo di dosaggio, concentrazione plasmatica massima del farmaco allo stato stazionario [Cmax,ss] durante un intervallo di dosaggio e concentrazione plasmatica minima del farmaco allo stato stazionario [Cmin,ss]) derivati dall’analisi PK di popolazione
    3. Variazione rispetto al basale del rapporto albumina/creatinina nelle urine (ACR) nel periodo di trattamento di 108 settimane
    4. Variazione rispetto al basale dell’eGFR nel periodo di trattamento di 108 settimane
    5. La percentuale di soggetti con un quadro istologico di glomerulosclerosi focale segmentaria (GSFS) e/o malattia a lesioni minime (MCD) che ottiene una remissione parziale, definita come UPC = 1,5 g/g e riduzione superiore al 40% di UPC nel periodo di trattamento 108 settimane
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1, day 2, week 12
    2. Day 1, day 2, week 12
    3. Baseline to all study visits to 108 weeks
    4. Baseline to all study visits to 108 weeks
    5. Baseline to all study visits to 108 weeks
    1. Giorno 1, giorno 2 , settimana 12
    2. Giorno 1, giorno 2 , settimana 12
    3. Dal Basale a tutte le visite dello studio a 108 settimane
    4.Dal Basale a tutte le visite dello studio a 108 settimane
    5.Dal Basale a tutte le visite dello studio a 108 settimane
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    United Kingdom
    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
    End of trial will be when the last subject completes his/her final visit.
    La fine dello studio ci sarà quando l'ultimo soggetto ccompleterà la sua ultima visita.
    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 days28
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days20
    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: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 38
    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) No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 57
    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)
    The Investigator should resume standard of care treatment, including treatment with appropriate medications, as deemed appropriate.
    Lo sperimentatore deve riprendere il trattamento di cura standard, compreso il trattamento con farmaci appropriati, se ritenuto appropriato.
    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 Decision2021-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
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