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    Summary
    EudraCT Number:2021-001404-14
    Sponsor's Protocol Code Number:QGC001-3QG2
    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:2021-08-27
    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 number2021-001404-14
    A.3Full title of the trial
    A Phase 3, Double-blind, Placebo-controlled and Open-label Efficacy and Long-term Safety Study of Firibastat (QGC001) Administered Orally, Once Daily, for Up to 48 Weeks in Patients with Difficult-to-treat/Resistant Hypertension.
    Studio di Fase 3, in doppio cieco ed in aperto, controllato con placebo per valutare l'efficacia e la sicurezza a lungo termine di firibastat (QGC001), somministrato per via orale una volta al giorno per un massimo di 48 settimane, in pazienti con ipertensione difficile da trattare/resistente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized study of Extended treatment with Firibastat in treatment-RESistant Hypertension
    Studio randomizzato di un trattamento prolungato con Firibastat nell'ipertensione trattamento resistente.
    A.3.2Name or abbreviated title of the trial where available
    REFRESH
    REFRESH
    A.4.1Sponsor's protocol code numberQGC001-3QG2
    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 SponsorQUANTUM GENOMICS
    B.1.3.4CountryFrance
    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 supportQuantum Genomics
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuantum Genomics
    B.5.2Functional name of contact pointBruno Besse
    B.5.3 Address:
    B.5.3.1Street Address33 Rue Marbeuf
    B.5.3.2Town/ cityPArigi
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33185347770
    B.5.5Fax number+33185347778
    B.5.6E-mailbruno.besse@quantum-genomics.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFiribastat
    D.3.2Product code [QGC001]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNFiribastat
    D.3.9.1CAS number 648927-86-0
    D.3.9.2Current sponsor codeQGC001
    D.3.9.3Other descriptive nameFIRIBASTAT
    D.3.9.4EV Substance CodeSUB33157
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of patients with difficult-to-treat and/or treatment-resistant hypertension (HTN).
    Trattamento di pazienti con ipertensione difficile da trattare o resistente.
    E.1.1.1Medical condition in easily understood language
    Treatment of patients with difficult-to-treat and/or treatment-resistant high blood pressure.
    Trattamento di pazienti con pressione sanguigna elevata difficile da trattare/resistente.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036695
    E.1.2Term Primary hypertension
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects of firibastat (QGC001) administered at 1000 mg orally (po) once daily (QD) on blood pressure (BP) over 12 weeks.
    Valutare gli effetti di firibastat (QGC001) somministrato a una dose di 1.000 mg per via orale (po) una volta al giorno (QD) sulla pressione arteriosa (PA) nell’arco di 12 settimane.
    E.2.2Secondary objectives of the trial
    • To assess the safety of firibastat (QGC001) administered at 1000 mg po QD over 24 weeks and 48 weeks.
    • To assess change in BP over time in subjects with uncontrolled primary HTN who have been treated with at least 2 classes of antihypertensive therapies at the maximum tolerated doses (MTDs) (ie, difficult-to-treat or treatment resistant patients).
    • valutare la sicurezza di firibastat (QGC001) somministrato a una dose di 1.000 mg po QD nell’arco di un periodo di 24 settimane e 48 settimane.
    • Valutare la variazione della PA nel tempo in soggetti con HTN primaria non controllata che sono stati trattati con almeno 2 classi di terapie antipertensive alle dosi massime tollerate (MTD) (ovvero, pazienti difficili da trattare o resistenti al trattamento).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand and willing to provide written informed consent, and able to comply with the study procedures and restrictions.
    2. Adult men and women (at Screening).
    3. Diagnosis of primary HTN for at least 6 months prior to Screening and:
    • Currently treated with 2 antihypertensive classes of drug (difficult-totreat subjects), or currently treated with at least 3 antihypertensive
    classes of drug including a diuretic (treatment resistant subjects), at the MTDs of those medications (ie, the subject can tolerate the current dose of each medication but higher doses have caused or may worsen side effects), with no change in their antihypertensive regimen (drug, dose, or schedule) for at least 6 weeks, and with medication adherence >or=80% during the Run in Period.
    • Have a systolic AOBP between 140 mmHg and 179 mmHg (inclusive) at Screening while on their current chronic antihypertensive treatments.
    • Have a successful ABPM measurement with a mean systolic daytime ABP >135 mmHg after the Run-in Period while on their current chronic antihypertensive treatments. An ABPM is successful if at least 21 daytime readings and 6 nighttime readings have been successfully recorded.
    4. Women of childbearing potential and nonsurgically sterile male subjects who are sexually active must agree to use an approved highly
    effective form of contraception from the time of informed consent until 30 days post dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depo, patch, or injectable) together with supplementary barrier methods such as condoms or diaphragms with spermicidal gel or foam.
    5. Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test
    result at the Inclusion Visit (Visit 2B, Day 1).
    1. In grado di comprendere e disposti a fornire il consenso informato scritto e in grado di conformarsi a tutte le procedure e le restrizioni dello studio.
    2. Uomini e donne adulti (allo screening).
    3. Diagnosi di HTN primaria per almeno 6 mesi prima dello screening e:
    • attualmente trattati con 2 classi di farmaci antipertensivi (soggetti difficili da trattare), o attualmente trattati con almeno 3 classi di farmaci antipertensivi, compreso un diuretico (soggetti resistenti al trattamento), alle MTD di tali farmaci (ovvero, il soggetto è in grado di tollerare la dose attuale di ciascun farmaco, ma dosi più elevate hanno causato o potrebbero peggiorare gli effetti collaterali); senza alcuna variazione nel regime antipertensivo (farmaco, dose, o programma) per almeno 6 settimane, e con aderenza al farmaco >o=80% durante il Periodo di run-in.
    • Presentano un’AOBP sistolica compresa tra 140 mmHg e 179 mmHg (inclusi) allo screening durante i loro attuali trattamenti antipertensivi cronici.
    • Presentano una misurazione andata a buon fine dell’ABPM con un’ABP sistolica diurna media >135 mmHg dopo il periodo di run-in durante i loro attuali trattamenti antipertensivi cronici. Un’ABPM va a buon fine se sono state registrate almeno 21 letture diurne e 6 letture notturne.
    4. Le donne in età fertile e i soggetti di sesso maschile non chirurgicamente sterili che sono sessualmente attivi devono accettare di utilizzare un metodo contraccettivo altamente efficace approvato dal momento del consenso informato fino a 30 giorni post-dose. Le forme di contraccezione approvate includono dispositivi intrauterini ormonali, contraccettivi ormonali (pillole contraccettive orali, formulazioni a lento rilascio, cerotto o iniettabili) insieme a metodi barriera supplementari come preservativi o diaframmi con gel o schiuma spermicida.
    5. Le donne in età fertile devono presentare un risultato negativo al test di gravidanza sul siero allo screening e un risultato negativo al test di gravidanza sulle urine alla Visita di inclusione (Visita 2B, Giorno 1).
    E.4Principal exclusion criteria
    1. Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
    2. Systolic AOBP >or=180 mmHg or DBP >or=110 mmHg at the Screening or Inclusion Visit (Visit 2B, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
    3. Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.
    4. Upper arm circumference that is outside the limits of the studyprovided BP cuff associated with either the ABPM and/or AOBP
    measurement device.
    5. History of spontaneous or drug-induced angioedema.
    6. History of any drug-related allergy or hypersensitivity to any components of the IP (firibastat [QGC001] or placebo).
    7. Known severe aortic stenosis (symptomatic or asymptomatic with valvular indexed surface <0.5 cm²/m²).
    8. Subjects with severe symptomatic heart failure (New York Heart Association [NYHA] Class III or Class IV).
    9. History of acute coronary syndrome (non-ST elevation myocardial infarction [MI], ST elevation MI, and unstable angina pectoris), stroke,
    or transient ischemic attack within 6 months prior to Visit 2A, Day 0.
    10. Known history of malabsorption syndrome, or has undergone gastrointestinal surgery, including bariatric procedures that induce
    chronic malabsorption, within 2 years of Screening.
    11. Treatment with anti-obesity drugs or procedures 3 months prior to Screening (ie, surgery, aggressive diet regimen, etc.), leading to
    unstable body weight.
    12. Female who is breastfeeding, pregnant, or planning to become pregnant during the study period.
    13. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 3 years.
    14. Shift workers who routinely sleep during the daytime and/or whose work hours include midnight.
    15. Subjects with moderate to severe hepatic impairment (Child-Pugh A, B, or C); alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >3×upper limit of normal (ULN), or
    a total bilirubin >or=1.5×ULN (unless secondary to Gilbert's syndrome), or direct bilirubin >ULN in subjects with Gilbert's syndrome at Screening.
    16. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (Levey AS, et al. 2009) at Screening.
    17. History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (eg, malaria, babesiosis, hemolytic anemia, thalassemia, sickle cell anemia).
    18. Subjects with documented DI.
    19. Subjects with Type 1 diabetes mellitus.
    20. Subjects with Type 2 diabetes mellitus who:
    • Are poorly controlled, defined as glycosylated hemoglobin A1c (HbA1c) >9% at Screening; OR
    • Are taking short-acting insulin. Use of a stable dose [>or=12 weeks prior to Screening] of the following medications, (or any combination of the following medications) is permitted: glucagon like peptide 1 analog, metformin, sulfonylurea, dipeptidyl peptidase-4 inhibitor, and single basal insulin, sodium glucose co-transporter 2 (SGLT2) inhibitors and pioglitazone.
    21. Routine or anticipated treatment with any systemic corticosteroid. Use of topical, inhaled, intra articular or nasal corticosteroids is
    permitted.
    22. Clinical evidence of thyroid disease, thyroid hormone therapy that is not stable or=4 weeks prior to Screening, or a thyroid-stimulating
    hormone (TSH) level <0.75×lower limit of normal or >1.5×ULN at Screening.
    23. History of alcohol or drug abuse (including opioid overuse/misuse) within the 3 months prior to Screening that would interfere with study participation or lead to decreased compliance to study procedures or IP intake in the investigator's opinion.
    [Please refer to the protocol as regards the other exclusion criteria]
    1. HTN secondaria nota o sospetta (ad es. iperaldosteronismo, HTN renovascolare, feocromocitoma, malattia di Cushing).
    2. AOBP sistolica >or=180 mmHg o DBP >or=110 mmHg alla Visita di screening o di inclusione (Visita 2B, Giorno 1) e confermata da una seconda misurazione entro 30 minuti fino a 1 ora.
    3. Retinopatia ipertensiva nota (di grado 3 o 4 di Keith-Wagener) e/o encefalopatia ipertensiva.
    4. Circonferenza della parte superiore del braccio al di fuori dei limiti del manicotto per la PA fornito dallo studio associato al dispositivo di misurazione dell’ABPM e/o AOBP.
    5. Anamnesi di angioedema spontaneo o farmaco-indotto.
    6. Anamnesi di qualsiasi allergia o ipersensibilità correlata al farmaco a qualsiasi componente dell’IP (firibastat [QGC001] o del placebo).
    7. Stenosi aortica grave nota (sintomatica o asintomatica con superficie valvolare indicizzata <0,5 cm²/m²).
    8. Soggetti con grave insufficienza cardiaca sintomatica (classe III o IV secondo la New York Heart Association [NYHA]).
    9. Anamnesi di sindrome coronarica acuta (infarto miocardico [IM] con elevazione non ST, IM con elevazione ST e angina pectoris instabile), ictus o attacco ischemico transitorio nei 6 mesi precedenti la Visita 2A, Giorno 0.
    10. Anamnesi nota di sindrome da malassorbimento o intervento chirurgico gastrointestinale, comprese le procedure bariatriche che inducono malassorbimento cronico, entro 2 anni dallo screening.
    11. Trattamento con farmaci o procedure anti-obesità 3 mesi prima dello screening (ovvero, intervento chirurgico, regime dietetico aggressivo, ecc.), con conseguente instabilità del peso corporeo.
    12. Donne che allattano al seno o in gravidanza o che prevedono di avviare una gravidanza durante il periodo dello studio.
    13. Anamnesi medica di tumore (ad eccezione del carcinoma basocellulare) e/o trattamento oncologico negli ultimi 3 anni.
    14. Lavoratori a turni che dormono regolarmente durante il giorno e/o le cui ore di lavoro includono la mezzanotte.
    15. Soggetti con insufficienza epatica da moderata a grave (classificazione di Child-Pugh A, B o C); alanina aminotransferasi (ALT), aspartato aminotransferasi (AST) o fosfatasi alcalina (ALP) >3× limite superiore della norma (Upper Limit of Normal, ULN) o bilirubina totale >or=1,5× ULN (a meno che non sia secondaria alla sindrome di Gilbert) o bilirubina diretta >ULN in soggetti con sindrome di Gilbert allo screening.
    16. Velocità di filtrazione glomerulare stimata (eGFR) <30 ml/min/1,73 m2, calcolata utilizzando la Formula di collaborazione epidemiologica per la malattia renale cronica (CKD-EPI) (Levey AS, et al. 2009) allo screening.
    17. Anamnesi di qualsiasi disturbo del sangue, diverso dal tratto a cellule falciformi, che causa emolisi o globuli rossi instabili (ad es., malaria, babesiosi, anemia emolitica, talassemia, anemia a cellule falciformi).
    18. Soggetti con DI documentato.
    19. Soggetti con diabete mellito di tipo 1.
    20. Soggetti con diabete mellito di tipo 2 che:
    • sono scarsamente controllati, definito come livelli di emoglobina glicosilata A1c (HbA1c) >9% allo screening; OPPURE
    • stanno assumendo insulina a breve durata d’azione. È consentito l’uso di una dose stabile [>or=12 settimane prima dello screening] dei seguenti farmaci (o di una qualsiasi combinazione dei seguenti farmaci): analoghi del peptide glucagone-simile 1, metformina, sulfonilurea, inibitori della dipeptidil peptidasi-4 e insulina basale singola, inibitori del co-trasportatore sodio-glucosio 2 (Sodium-Glucose co-Transporter 2, SGLT2) e pioglitazone.
    21. Trattamento di routine o previsto con qualsiasi corticosteroide sistemico. È consentito l’uso di corticosteroidi topici, inalatori, intra-articolari o nasali.
    [Si prega di fare riferimento alla sinossi del protocollo in italiano per i restanti criteri di esclusione].
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline in systolic AOBP at Week 12.
    L’endpoint primario di efficacia è la variazione rispetto al basale della AOBP sistolica alla Settimana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12.
    Settimana 12.
    E.5.2Secondary end point(s)
    - AOBP at every visit.
    - 24-hour ambulatory BP monitoring (ABPM) assessed at baseline and after 12 weeks (end of double-blind period [Period 1]).
    - Biomarker N-terminal pro-B-type natriuretic peptide (NT-ProBNP) - change from baseline to Visit 4B, Day 85 (±3 d).
    - Proportion of subjects requiring an increase in the dose of current antihypertensive drugs or addition of another hypertensive drug during the open-label treatment periods (Periods 2 and 3) of the study.
    - AOBP ad ogni visita.
    - PA monitorata in modo continuo nelle 24 ore dopo 12 settimane (fine del periodo in doppio cieco [Periodo 1]).
    - Biomarcatore NT-ProBNP alla Visita 2B, Giorno 1 e Visita 4B, Giorno 85 (±3 gg) rispetto al basale.
    - Percentuale di soggetti che richiede un aumento della dose di farmaci antipertensivi attuali o l’aggiunta di un altro farmaco antipertensivo durante i periodi di trattamento in aperto (Periodo 2 e 3) dello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - AOBP at every visit.
    - 24-hour ambulatory BP at baseline and after 12 weeks.
    - Biomarker NT-ProBNP at Visit 2B, Day 1, and Visit 4B, Day 85 (±3 d).
    - AOBP ad ogni visita.
    - PA monitorata per 24 ore in ambulatorio al basale e dopo 12 settimane.
    - Biomarcatore NT-ProBNP alla Visita 2B, Giorno 1, e Visita 4B, Giorno 85 (±3 d).
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Studio di efficacia in aperto e di sicurezza a lungo termine.
    Open-label Efficacy and Long-term Safety Study.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA40
    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
    Canada
    Korea, Republic of
    Russian Federation
    Taiwan
    United States
    Belgium
    France
    Hungary
    Italy
    Poland
    Slovakia
    Spain
    Czechia
    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.
    Ultima visita dell'ultimo soggetto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days25
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 430
    F.4.2.2In the whole clinical trial 750
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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