Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-004835-26
    Sponsor's Protocol Code Number:D169AL00005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-02
    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 number2020-004835-26
    A.3Full title of the trial
    Single-center, randomized, controlled study to evaluate the effects of a six-month treatment with renal glucose transport inhibitor (SGLT2i) drugs on markers of senescence, inflammation and tubulointerstitial damage in the kidney of patients with chronic kidney disease with or without type 2 diabetes
    Studio monocentrico, randomizzato, controllato, per valutare gli effetti di un trattamento di sei mesi con farmaci inibitori del trasporto renale del glucosio (SGLT2i) sui marcatori di senescenza, infiammazione e danno tubulo-interstiziale nel rene dei pazienti con malattia renale cronica con o senza diabete tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Single-center, randomized, controlled study to evaluate the effects of a six-month treatment with renal glucose transport inhibitor (SGLT2i) drugs on markers of senescence, inflammation and tubulointerstitial damage in the kidney of patients with chronic kidney disease with or without type 2 diabetes
    Studio monocentrico, randomizzato, controllato, per valutare gli effetti di un trattamento di sei mesi con farmaci inibitori del trasporto renale del glucosio (SGLT2i) sui marcatori di senescenza, infiammazione e danno tubulo-interstiziale nel rene dei pazienti con malattia renale cronica con o senza diabete tipo 2
    A.3.2Name or abbreviated title of the trial where available
    GLUTREPRO
    GLUTREPRO
    A.4.1Sponsor's protocol code numberD169AL00005
    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-A.O.U. SAN MARTINO-IST
    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 supportAstraZeneca SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Ospedale Policlinico San Martino
    B.5.2Functional name of contact pointCentro Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressIRCCS Ospedale Policlinico San Martino - Largo R. Benzi, 10
    B.5.3.2Town/ cityGenova
    B.5.3.3Post code16132
    B.5.3.4CountryItaly
    B.5.4Telephone number0105558476
    B.5.5Fax number010354103
    B.5.6E-mailluca.boni@hsanmartino.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.2.1.2Country 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 nameDapagliflozin
    D.3.2Product code [SGLT2i]
    D.3.4Pharmaceutical form Gastro-resistant 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 INNDAPAGLIFLOZIN
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeBMS-512148-05
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 Yes
    D.3.11.13.1Other medicinal product typeInibitore trasporto renale del glucosio
    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 placeboGastro-resistant tablet
    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
    Chronic Kidney Deseas
    Insufficienza renale cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Deseas
    Malattia renale cronica
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10050441
    E.1.2Term Chronic renal insufficiency
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the role of dapagliflozin in confront to placebo on changes in markers of inflammation, on the activation of innate immunity and tubulointerstitial fibrosis in the kidney of patients with CKD.
    Valutare il ruolo di dapagliflozin rispetto al placebo sui cambiamenti nei marker di infiammazione, sull'attivazione dell'immunità innata e della fibrosi tubulointerstiziale nel rene di pazienti con CKD.
    E.2.2Secondary objectives of the trial
    The secondary objective is to describe changes from baseline in albuminuria, eGFR, blood pressure, body volume status, body weight, serum uric acid, lipids, glucose and HbA1c levels, after 6 months of treatment with dapagliflozin or placebo and to define their relationship with the changes in the markers of renal senescence, inflammation and tubulointerstitial damage.
    Descrivere le variazioni rispetto al basale di albuminuria, eGFR, pressione sanguigna, stato del volume corporeo, peso corporeo, acido urico sierico, lipidi, glucosio e livelli di HbA1c, dopo 6 mesi di trattamento con dapagliflozin o placebo e definire la loro relazione con i cambiamenti nei marker di senescenza renale, infiammazione e danno tubulo-interstiziale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult (age 18-75 years)
    - Albuminuria defined as urinary albumin ratio: creatinine = 25 mg / g (or protein ratio: creatinine = 30 mg / g) or albuminuria> 30 mg / 24h
    - eGFR> 25 and <75 ml / minute 1.73 m2
    - BMI between 19 kg / m2 and 30 kg / m2
    - Treatment with an ACE inhibitor and / or ARB at the maximum tolerated dose (for the individual subject). The maximum tolerated dose for an individual subject may be less than the maximum labeled dose or may be zero if the medical reason is documented.
    - Mean systolic and diastolic blood pressure (determined as the average of three repeated measurements) should be <180/90 mmHg
    - Willingness to participate in the study (signing of informed consent)

    Specific inclusion criteria

    CKD AND T2DM
    - Clinical diagnosis of T2DM for at least 1 year
    - Value of hemoglobin A1c (HbA1c) <9.5%
    -Patients treated only with metformin and/or repaglinide
    - Diagnosis of diabetic nephropathy after renal biopsy made not more than 6 months before the screening visit (only for the subgroup of patients candidates for the second renal biopsy)
    - Proteinuria> 1g / 24h (only for the subgroup of patients candidates for the second renal biopsy)
    - Hemoglobin A1c (HbA1c) value> 6.5% (only for patients candidates for the second renal biopsy)

    CKD WITHOUT T2DM
    diagnosed with hypertension for at least 5 years
    - Adulto (età 18-75 anni)
    - Albuminuria definita come rapporto albumina urinaria: creatinina = 25 mg / g (o rapporto proteine: creatinina = 30 mg / g) o albuminuria> 30 mg / 24h
    - eGFR> 25 e <75 ml / minuto 1,73 m2
    - BMI compreso tra 19 kg / m2 e 30 kg / m2
    - Trattamento con un ACE inibitore e / o ARB alla dose massima tollerata (per il singolo soggetto). La dose massima tollerata per un singolo soggetto può essere inferiore alla dose massima etichettata o può essere zero se la ragione medica è documentata.
    - La pressione sanguigna sistolica e diastolica media (determinata come la media di tre misure ripetute) deve essere <180/90 mmHg
    - Disponibilità a partecipare allo studio (firma del consenso informato)

    CKD E T2DM
    - Diagnosi clinica di T2DM da almeno 1 anno
    - Valore dell'emoglobina A1c (HbA1c) <9,5%
    - Pazienti trattati solo con metformina e / o repaglinide
    - Diagnosi di nefropatia diabetica dopo biopsia renale eseguita non più di 6 mesi prima della fase di run-in (solo per il sottogruppo di pazienti candidati alla seconda biopsia renale)
    - Proteinuria> 1g / 24h (solo per il sottogruppo di pazienti candidati alla seconda biopsia renale)
    - Valore dell'emoglobina A1c (HbA1c)> 6,5% (solo per i pazienti candidati alla seconda biopsia renale)

    CKD SENZA T2DM
    - diagnosi di ipertensione da almeno 5 anni
    E.4Principal exclusion criteria
    • Type 1 Diabetes
    • Hemoglobin A1c (HbA1c) value of > 9.5% during the Screening period (based on central laboratory measurement).
    • need for an adjunctive drugs on top on metformin and repaglinide
    • Hemoglobin A1c (HbA1c) value of < 6.5% only for patients candidated to the second kidney biopsy
    • Estimated glomerular filtration rate < 25 or > 75 ml/min/1.73m2 (according to the CKD-EPI) at screening
    • Untreated urinary or genital infection at screening and follow-up
    • Clear signs of volume depletion
    • Symptomatic hypotension, or systolic blood pressure < 90 or non-controlled hypertension
    • History of alcohol or drug abuse, anuria, dialysis, or acute kidney injury/acute renal failure in the 3 months prior to Screening Period
    • Heart, liver or kidney transplant
    • Acute coronary syndrome, stroke, or transient ischemic attack within 3 months prior to informed consent
    • Liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal (ULN) during screening
    • Planned cardiac surgery or angioplasty within 3 months
    • Cancer or medical history of cancer (except for basal cell carcinoma) within the last 5 years
    • Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight (e.g. surgery, aggressive diet regimen, etc.)
    • SGLT2i treatment in the 10 weeks before the Screening Period
    • Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
    • Any uncontrolled endocrine disorder except T2DM
    • Women who are pregnant or breastfeeding
    • Pre-menopausal women of child bearing potential who are not willing to employ effective contraception according to 2007 CTFG Recommendations related to contraception and pregnancy testing in clinical trials from screening for all the duration of the study
    • Patients with a known hypersensitivity to Dapagliflozin or other SGLT2- inhibitors, including hypersensitivity to excipients (e.g. lactose)
    • History of pancreatitis, or pancreatic surgery, diabetic ketoacidosis
    • Prior lower extremity amputation or current threat of amputation (eg, lower extremity ulcer and peripheral artery disease)
    • History of severe hypoglycaemia and hypoglycaemia unawareness.
    • Contraindication to MRI
    - Diabete di tipo 1
    • Valore dell'emoglobina A1c (HbA1c)> 9,5% durante il periodo di screening (basato sulla misurazione del laboratorio centrale).
    • Necessità di trattamento aggiuntivo oltre a metformina e/o repaglinide
    • Valore dell'emoglobina A1c (HbA1c) <6,5% solo per i pazienti candidati alla seconda biopsia renale
    • Velocità di filtrazione glomerulare stimata <25 o> 75 ml / min / 1,73 m2 (secondo CKD-EPI) allo screening
    • Infezione urinaria o genitale non trattata allo screening e al follow-up
    • Chiari segni di esaurimento del volume
    • Ipotensione sintomatica o pressione sanguigna sistolica <90 o ipertensione non controllata
    • Storia di abuso di alcol o droghe, anuria, dialisi o danno renale acuto / insufficienza renale acuta nei 3 mesi precedenti il periodo di screening
    • Trapianto di cuore, fegato o rene
    • Sindrome coronarica acuta, ictus o attacco ischemico transitorio nei 3 mesi prima del consenso informato
    • Malattia epatica, definita dai livelli sierici di alanina aminotransferasi, aspartato aminotransferasi o fosfatasi alcalina superiori a 3 volte il limite superiore della norma (ULN) durante lo screening
    • Cardiochirurgia o angioplastica programmata entro 3 mesi
    • Cancro o storia medica di cancro (ad eccezione del carcinoma basocellulare) negli ultimi 5 anni
    • Trattamento con farmaci anti-obesità nei 3 mesi prima del consenso informato o qualsiasi altro trattamento al momento dello screening che porta a un peso corporeo instabile (ad es. Chirurgia, dieta aggressiva, ecc.)
    • Trattamento SGLT2i nelle 10 settimane precedenti il periodo di screening
    • Trattamento con steroidi sistemici al momento del consenso informato o modifica del dosaggio degli ormoni tiroidei entro 6 settimane prima del consenso informato
    • Qualsiasi disturbo endocrino non controllato eccetto T2DM
    •Gravidanza o allattamento
    •Donne in età fertile che non praticano contraccezione
    • Pazienti con ipersensibilità nota a Dapagliflozin o altri inibitori del SGLT2, inclusa ipersensibilità agli eccipienti (ad es. Lattosio).
    • Storia di pancreatite o chirurgia pancreatica, chetoacidosi diabetica
    • Precedente amputazione degli arti inferiori o pericolo di amputazione ( Es., Ulcera degli arti inferiori e malattia delle arterie periferiche).
    • Storia di ipoglicemia grave e inconsapevolezza di ipoglicemia.
    • Controindicazione alla risonanza magnetica
    E.5 End points
    E.5.1Primary end point(s)
    1) In the proximal tubule cells of the whole study population, changes in:

    a) protein expression of target inflammatory genes (such as p16ink4a, TLR-4, phospho-p65, DKK3, Myostatin, TGFß, SMAD 2,3 and MAPK pathways) and in epithelial-mesenchymal transition (EMT).

    b) target genes of inflammation, apoptosis, senescence such as type IV collagen fibronectin, TGF-ß, TNF receptor 1, EMF cadherin production, NF-kB, MCP-1 , DKK3, myostatin and Activin A responses.


    2) In the first six patients with T2DM, proteinuria > 1 g/day and biopsy proven diabetic kidney disese allocated to the treatment with dapagliflozin, changes in the protocol kidney biopsy at the end of the treatment period will be evaluated as follows:

    a) expression and location of senescence (p16inkA, SA-beta-galactosidase), and apoptosis markers (TNF receptor 1, EMF cadherin NF-kB).
    b) target inflammatory gene responses (of inflammation, apoptosis, senescence such as type IV collagen fibronectin, TGF-ß, TNF receptor 1, EMF cadherin production, NF-kB, MCP-1 , DKK3, myostatin and Activin A activation)
    c) expression and location of pro-inflammatory cytokine expression in kidney biopsies (for pro-inflammatory and pro-fibrotic cytokines expression such as MCP-1, DKK3, TLR-4, CCR-2, Myostatin, TGFß and Activin A will be evaluated by immunohistochemistry)
    1) Nelle cellule tubulari prossimali dell'intera popolazione in studio, cambiamenti in:
    a) espressione proteica dei geni infiammatori bersaglio (come p16ink4a, TLR-4, fosfo-p65, DKK3, Miostatina, TGFß, SMAD 2,3 e MAPK pathways) e nella transizione epiteliale-mesenchimale (EMT).
    b) geni bersaglio di infiammazione, apoptosi, senescenza come fibronectina di collagene di tipo IV, TGF-ß, recettore 1 del TNF, produzione di caderina EMF, risposte NF-kB, MCP-1, DKK3, miostatina e Activina A.

    2) Nei primi sei pazienti con T2DM, proteinuria> 1 g / die e malattia renale diabetica comprovata da biopsia assegnata al trattamento con dapagliflozin, le modifiche al protocollo biopsia renale al termine del periodo di trattamento saranno valutate come segue:
    a) espressione e localizzazione della senescenza (p16inkA, SA-beta-galattosidasi) e marcatori di apoptosi (recettore 1 del TNF, caderina EMF NF-kB).
    b) risposte di geni target (di infiammazione, apoptosi, senescenza come fibronectina di collagene di tipo IV, TGF-ß, recettore TNF 1, produzione di caderina EMF, NF-kB, MCP-1, DKK3, miostatina e attivazione di Activin A)
    c) espressione e localizzazione dell'espressione di citochine pro-infiammatorie nelle biopsie renali (sarà valutata l'espressione di citochine pro-infiammatorie e pro-fibrotiche come MCP-1, DKK3, TLR-4, CCR-2, Miostatina, TGFß e Activin A per immunoistochimica)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 and 24 weeks
    12 settimane e 24 settimane
    E.5.2Secondary end point(s)
    a) Changes in global and segmental renal oxygenation estimated by BOLD MRI (changes in R2* value defined as 1/T2*)
    b) Changes in urinary markers of a proxy of interstitial fibrosis in patients with CKD (Mir 20)
    c) Changes in urinary albumin excretion, eGFR, serum uric acid, HbA1c, lipid profile and body weight, blood pressure levels measured by ABPM and in the need of antihypertensive drugs
    a) Cambiamenti nell'ossigenazione renale globale e segmentale stimati da RM BOLD (variazioni nel valore R2 * definito come 1 / T2 *)
    b) Cambiamenti nei marker urinari di un proxy di fibrosi interstiziale in pazienti con CKD (Mir 20)
    c) Cambiamenti nell'escrezione urinaria di albumina, eGFR, acido urico sierico, HbA1c, profilo lipidico e peso corporeo, livelli di pressione sanguigna misurati con ABPM e necessità di farmaci antipertensivi
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 24 weeks
    12 e 24 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 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 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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 38
    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)
    Patients will continue to be followed up at the center according to normal clinical practice
    I pazienti continueranno ad essere seguiti presso il centro secondo normale pratica clinica
    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 Decision2021-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-10-31
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 23 22:23:44 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA