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    Summary
    EudraCT Number:2019-003607-35
    Sponsor's Protocol Code Number:C0221002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-08-02
    Trial results View 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 number2019-003607-35
    A.3Full title of the trial
    A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
    STUDIO DI FASE 2, DELLA DURATA DI 12 SETTIMANE, ADATTIVO, IN APERTO, A COORTI SEQUENZIALI PER VALUTARE L’EFFICACIA, LA SICUREZZA, LA TOLLERABILITÀ E LA FARMACOCINETICA DI PF-06730512 DOPO DOSI MULTIPLE IN SOGGETTI ADULTI CON GLOMERULOSCLEROSI FOCALE SEGMENTARIA (FSGS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
    Studio per valutare PF-06730512 in adulti con Glomerulosclerosi Focale Segmentaria (FSGS)
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberC0221002
    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 SponsorPFIZER 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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 namePF-06730512
    D.3.2Product code [PF-06730512]
    D.3.4Pharmaceutical form Powder 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 INNPF-06730512
    D.3.9.2Current sponsor codePF-06730512
    D.3.9.3Other descriptive namePF-06730512
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Focal Segmental Glomerulosclerosis (FSGS)
    Glomerulosclerosi Focale Segmentaria (FSGS)
    E.1.1.1Medical condition in easily understood language
    Kidney disease
    Nefropatia
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067757
    E.1.2Term Focal segmental glomerulosclerosis
    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
    To evaluate the efficacy of PF-06730512 compared to baseline in the reduction of proteinuria following 12 weeks of treatment in patients with FSGS.
    Valutare l’efficacia di PF-06730512 rispetto al basale nella riduzione della proteinuria in seguito a 12 settimane di trattamento in pazienti con FSGS.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of PF-06730512 following 12 weeks of treatment in subjects with FSGS.
    - To evaluate the effects of PF-06730512 on proteinuria time course.
    - To summarize complete and partial remission rates following administration of PF-06730512.
    - To evaluate the effect of PF-06730512 on renal function.
    - To evaluate the serum exposure of PF-06730512 in FSGS patients.
    - To evaluate the immunogenicity profile of PF-06730512.
    - Valutare la sicurezza e la tollerabilità di PF-06730512 dopo 12 settimane di trattamento in soggetti con
    FSGS.
    - Valutare gli effetti di PF-06730512 sull’andamento temporale della proteinuria.
    - Riepilogare i tassi di remissione completa e parziale in seguito alla somministrazione di PF-06730512.
    - Valutare l’effetto di PF-06730512 sulla funzione renale.
    - Valutare l’esposizione sierica a PF-06730512 in pazienti affetti da FSGS.
    - Valutare l’immunogenicità di PF-06730512.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    2. Male or female subject age =18 years must have a confirmed diagnosis of FSGS defined as a minimum of 1 glomerulus demonstrating segmental sclerosis on light microscopy within the past 5 years.
    - Estimated glomerular filtration rate (eGFR) =45 ml/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) formula, with repeat measurements permitted, as appropriate.
    3. If eGFR is 30-45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate <50% tubulo-interstitial fibrosis. The Investigator and the subject may decide to perform a biopsy which might fulfill this eligibility criterion.
    4. UPCR >1.5 g protein/g creatinine at Screening.
    5. Based on all previous treatment received for FSGS, subject is eligible if:
    a. Subject has been treated with at least 1, and up to 3 classes of Immunosuppressants* either alone or in combination;
    OR
    b. Subject has a contraindication to any class of Immunosuppressant (may include steroids) or is considered to be intolerant to any class of Immunosuppressant (may include steroids) per Investigator judgment.
    6. For inclusion into the Lead-in Period, subjects on ongoing corticosteroid treatment must have discontinued steroid treatment or tapered down to a stable prednisone dose =7.5 mg per day (or 15 mg q.o.d.) or other steroid equivalent at least one week prior to the Lead-in Period. Treatment with CNIs OR MMF (but not both) may be continued upon entry into the Lead-in Period at the discretion of the Principal
    Investigator. Treatment with the agent (CNIs or MMF) must have been ongoing for at least 6 months prior to Lead-in, and the dose (or level) of the agent must have been stable for at least 1 month prior to the Lead-in Period.
    7. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and
    other study procedures including completion of daily diaries to record symptoms and
    urine collections.
    8. Female subjects of non-childbearing potential will meet at least 1 of the following criteria (all other female subjects, including female subjects with tubal ligations, are considered to be of childbearing potential):
    a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with/and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
    b. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    c. Have medically confirmed ovarian failure.
    1. Prova di un documento di consenso informato personalmente firmato e datato, che indichi che il soggetto è stato informato in merito a tutti gli aspetti pertinenti allo studio.
    2. Soggetto di sesso maschile o femminile di età =18 anni con diagnosi confermata di FSGS definita come un minimo di 1 glomerulo che dimostri sclerosi segmentaria al microscopio ottico negli ultimi 5 anni.
    - Se un soggetto non si è sottoposto a una biopsia che confermi la diagnosi di FSGS negli ultimi 5 anni, lo sperimentatore e il soggetto possono decidere di eseguire una biopsia, per soddisfare eventualmente questo criterio di idoneità.
    3. Velocità di filtrazione glomerulare stimata (eGFR) =45 ml/min/1,73 m2 in base alla formula dell’epidemiologia della malattia renale cronica (CKD-EPI), con misurazioni ripetute consentite, come appropriato.
    - Se l’eGFR è 30-45 ml/min/1,73 m2, una recente biopsia (nei 12 mesi prima dello screening) deve dimostrare <50% di fibrosi tubulo-interstiziale. Lo sperimentatore e il soggetto possono decidere di eseguire una biopsia, che potrebbe soddisfare questo criterio di idoneità.
    4. UPCR >1,5 g di proteina/g di creatinina allo screening.
    5. Sulla base di tutti i precedenti trattamenti ricevuti per la FSGS, il soggetto è idoneo
    se:
    a. Il soggetto è stato trattato con almeno 1, e fino a 3 classi di immunosoppressori* in monoterapia o in combinazione;
    OPPURE
    b. Il soggetto ha una controindicazione a qualsiasi classe di immunosoppressori (possono essere inclusi gli steroidi) o è ritenuto intollerante a qualsiasi classe di immunosoppressori (possono essere inclusi gli steroidi) secondo il parere dello Sperimentatore.
    6. Per l’inclusione nel periodo di lead-in, i soggetti sottoposti a trattamento con corticosteroidi in corso devono avere sospeso il trattamento con steroidi o ridotto gradualmente fino a una dose stabile di prednisone =7,5 mg al giorno (o 15 mg q.o.d.) o altro steroide equivalente almeno una settimana prima del periodo di lead-in. Il trattamento con CNI O MMF (ma non entrambi) può essere continuato al momento dell’ingresso nel periodo di lead-in, a discrezione dello sperimentatore principale. Il trattamento con l’agente (CNI o MMF) deve essere in corso da almeno sei mesi prima del lead-in e la dose (o livello) dell’agente deve essere stabile da almeno un mese prima del periodo di lead-in.
    7. Soggetti che intendono e sono in grado di rispettare le visite programmate, il piano di trattamento, i test di laboratorio e le altre procedure previste dallo studio, compresa la compilazione di diari giornalieri per registrare i sintomi e le raccolte di urine.
    8. I soggetti di sesso femminile non potenzialmente fertili devono soddisfare almeno uno dei seguenti criteri (tutti gli altri soggetti di sesso femminile, compresi i soggetti di sesso femminile con legatura delle tube, sono considerati in età fertile):
    a. essere in fase postmenopausale, definita come segue: cessazione del normale ciclo mestruale da almeno 12 mesi consecutivi in assenza di altra causa patologica o fisiologica; lo stato può essere confermato dalla presenza di un livello sierico di ormone follicolo-stimolante (FSH) che confermi lo stato di
    post-menopausa;
    b. aver subito un’isterectomia e/o un’ovariectomia bilaterale documentate;
    c. presentare insufficienza ovarica clinicamente confermata.
    E.4Principal exclusion criteria
    1. Diagnosis of collapsing FSGS.
    2. Advanced chronic changes on renal biopsy as evidenced by >50% tubulo-interstitial fibrosis.
    3. Evidence or history of clinically significant hematological, endocrine (including Type 1 diabetes mellitus), pulmonary, gastrointestinal,
    cardiovascular, hepatic, psychiatric, neurological, or hepatic disease, like cirrhosis or chronic active liver disease.
    4. Organ transplantation.
    5. History of any malignancy except for subjects who had a basal or squamous cell skin cancer which has been treated and fully resolved for
    a minimum of 5 years.
    6. Body mass index (BMI) >45 kg/m2 (based on an estimated dry weight as per judgment of the Investigator, if applicable)
    7. Treatment with rituximab within 6 months prior to start of the Lead-in Period. If Rituximab treatment is longer than 6 months (prior to start of
    the Lead-in Period), subject is still excluded if no peripheral CD19+ Bcells are identified in the local laboratory prior to first study drug dosing.
    8. Any immunosuppressant medication (besides corticosteroids, MMF, or CNIs) within the past 28 days prior to start of the Lead-in Period.
    9. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 5 ounces (45 mL) of hard liquor)] within the previous 6 months.
    10. Screening sitting blood pressure (BP) =155 mm Hg (systolic) or =95 mm Hg (diastolic), following at least 5 minutes of sitting rest. If BP is =155 mm Hg (systolic) or =95 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject’s eligibility. Repeat BP measurements on a different day are allowed to meet this eligibility criterion. Note: Repeat BP measurement should be done within designated screening window and may be considered as unplanned visit.
    11.Active/serious infection (including, but not limited to Hepatitis B or C, human immunodeficiency virus (HIV). This includes subjects with a known history of CMV disease, CMV mononucleosis, gammaherpesviral mononucleosis, parvovirus infection, or simian virus 40 infection.
    12.Subjects with a history of bilateral vesicoureteral reflux.
    13.Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors, testosterone/anabolic steroids, anthracycline (doxorubicin), heroin.
    14.Subjects with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and confirmed by a repeat test, if deemed necessary:
    a.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level 1.5× upper limit of normal (ULN);
    b.Total bilirubin level 1.5× ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is = ULN.
    For full list of exclusion criteria please refer to Study Protocol.
    1. Diagnosi di FSGS con collasso.
    2. Modifiche croniche avanzate alla biopsia renale, come dimostrato da fibrosi tubulo-interstiziale >50%.
    3. Evidenza o anamnesi di patologia ematologica, endocrina (incluso il diabete mellito di tipo 1), polmonare, gastrointestinale, cardiovascolare, epatica, psichiatrica, neurologica o epatica, come cirrosi o epatopatia cronica attiva clinicamente significativa.
    Si noti quanto segue:
    - Il diabete indotto da steroidi non è escluso.
    - Il diabete mellito di tipo 2 non è escluso in presenza di una recente biopsia (nei 12 mesi precedenti lo screening) che non mostri alcun cambiamento istologico indicante nefropatia diabetica. Lo sperimentatore principale e il soggetto possono decidere di eseguire una biopsia diagnostica, al fine di soddisfare eventualmente questo criterio di idoneità. Nota: il soggetto può essere considerato escluso se, a
    giudizio dello sperimentatore, il suo diabete è scarsamente controllato.
    4. Trapianto di organo.
    5. Anamnesi di qualsiasi tumore maligno, ad eccezione dei soggetti colpiti da carcinoma cutaneo a cellule basali o squamose trattato e completamente risolto da almeno 5 anni.
    6. Indice di massa corporea (IMC) >45 kg/m2 (in base a una stima del peso secco secondo il giudizio dello sperimentatore, se applicabile).
    7. Trattamento con rituximab entro 6 mesi prima dell’inizio del periodo di lead-in.
    - Se il trattamento con Rituximab supera i 6 mesi (prima dell’inizio del periodo di lead-in), il soggetto è comunque escluso se non sono identificati linfociti B CD19+ nel sangue periferico da parte del laboratorio locale prima della prima somministrazione del farmaco dello studio.
    8. Qualsiasi farmaco immunosoppressore (oltre a corticosteroidi, MMF o CNI) negli ultimi 28 giorni prima dell’inizio del periodo di lead-in.
    9. Anamnesi di consumo regolare di alcol superiore a 14 bevande a settimana per le donne o 21 bevande a settimana per i soggetti di sesso maschile (1 bevanda = 150 ml di vino o 360 ml di birra o 45 ml di superalcolico) nei precedenti 6 mesi.
    10. Screening: pressione sanguigna da seduti (BP) =155 mmHg (sistolica) o =95 mmHg (diastolica), dopo almeno 5 minuti di riposo in posizione seduta. Se la pressione sanguigna è =155 mmHg (sistolica) o =95 mmHg (diastolica), la misurazione deve essere ripetuta altre 2 volte e per determinare l’idoneità del soggetto deve essere utilizzata la media dei 3 valori della pressione. Per soddisfare questo criterio di
    idoneità, è consentito ripetere le misurazioni della pressione sanguigna in un giorno diverso. Nota: la ripetizione della misurazione della pressione sanguigna dovrà essere effettuata entro la finestra di screening prevista e può essere considerata come visita non programmata.
    11. Infezione attiva/grave (tra cui, ma non a titolo esclusivo, epatite B o C, virus dell’immunodeficienza umana [HIV]). Ciò comprende i soggetti con anamnesi nota di malattia da CMV, mononucleosi da CMV, mononucleosi da gamma herpesvirus, infezione da parvovirus o infezione da simian virus 40.
    12. Soggetti con anamnesi di reflusso vescico-ureterale bilaterale.
    13. Soggetti con anamnesi di precedente trattamento con o uso di interferone, litio, pamidronato, inibitori di mTOR, testosterone/steroidi anabolizzanti, antraciclina (doxorubicina), eroina.
    14. Soggetti che presentano QUALSIASI anomalia fra le seguenti relativa ai test clinici di laboratorio allo screening, come valutato dal laboratorio specifico dello studio e confermato dalla ripetizione di un test, se ritenuto necessario:
    a.Livello di aspartato aminotransferasi (AST) o alanina aminotransferasi
    (ALT) >1,5 volte il limite superiore della norma (ULN);
    b.Bilirubina totale 1,5 volte l’ULN; i soggetti con anamnesi di sindrome di Gilbert possono essere sottoposti a misurazione della bilirubina diretta e saranno considerati idonei per questo studio se il livello di bilirubina
    diretta sarà =ULN.
    Per l'elenco completo dei criteri di inclusione si prega di fare riferimento al protocollo di studio.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline to Week 13 in Urinary Protein to Creatinine Ratio (UPCR).
    Variazione percentuale dal basale alla settimana 13 nel rapporto proteine-creatinina nelle urine (UPCR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 13
    Settimana 13
    E.5.2Secondary end point(s)
    - Adverse Events, Laboratory Safety Tests (Hematology, Clinical
    Chemistry, Urinalysis), Body Weight, Blood Pressure, Pulse Rate, oral
    temperature and Electrocardiogram (ECG).
    - Percentage change from baseline to Weeks 3, 5 and 9 in UPCR.
    - Partial and complete remission of proteinuria at Week 13.
    - Percentage change from baseline to Weeks 3, 5, 9 and 13 in estimated glomerular filtration rate (eGFR).
    - Serum concentration of PF-06730512.
    - Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb).
    - Eventi avversi, esami di sicurezza di laboratorio (ematologia, chimica clinica, analisi delle urine), peso corporeo, pressione arteriosa, frequenza cardiaca, temperatura orale ed elettrocardiogramma (ECG).
    - Variazione percentuale di UPCR rispetto al basale alle Settimane 3, 5 e 9.
    - Remissione parziale e completa della proteinuria alla Settimana 13.
    - Variazione percentuale rispetto al basale alle Settimane 3, 5, 9 e 13 della velocità di filtrazione
    glomerulare stimata (eGFR).
    - Concentrazione sierica di PF-06730512.
    - Incidenza dello sviluppo di anticorpi anti-farmaco (ADA) e anticorpi neutralizzanti (NAb).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 3, 5, 9 and 13 (see above)
    Settimane 3, 5, 9 e 13 (vedere sopra).
    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 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 No
    E.8.1.2Open Yes
    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 Yes
    E.8.1.7.1Other trial design description
    studio sequenziale
    sequential study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 EEA30
    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
    Japan
    United States
    France
    Germany
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days21
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 44
    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 Decision2020-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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