Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Studio non interventistico di pazienti affetti da amiloidosi da transtiretina (ATTR). (MaesTTRo)

22 settembre 2026 aggiornato da: AstraZeneca

Uno studio non interventistico, prospettico, multinazionale che raccoglie dati reali sulle caratteristiche, i modelli di trattamento e gli esiti dei pazienti affetti da amiloidosi da transtiretina (ATTR)

The MaesTTRo study aims to enroll a global cohort of patients with transthyretin (ATTR) amyloidosis to longitudinally observe the natural course of the disease and describe real-world treatment patterns and outcomes. In addition, information on the effectiveness of ATTR amyloidosis treatments, including eplontersen, which is a ligand-conjugated antisense oligonucleotide gene silencing treatment targeting activity against both the mutant and wild-type TTR protein, will be collected.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Reclutamento

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Descrizione dettagliata

MaesTTRo is an international, longitudinal, non-interventional study of adult patients with transthyretin (ATTR) amyloidosis.

The study plans to enroll a minimum of 1850 patients with ATTR amyloidosis, including a minimum of 850 patients with ATTR cardiomyopathy (ATTR-CM), and a minimum of 100 patients with ATTRv-PN hereditary polyneuropathy.

The enrollment period is expected to last approximately 4 years. The duration of follow-up for each patient will be at least 3 years and up to 7 years depending on the date when the patient is enrolled.

This study design will include both primary and secondary data. Primary data will consist of patient-reported outcome (PRO) questionnaires. Patients will be asked to complete electronic PRO questionnaires at enrollment and every 6 months (±3 months) only during routine visits. Secondary data will consist of demographic, clinical, and treatment information, and will be collected as per routine clinical practice. These data will be abstracted directly from the electronic health record or review of paper charts for each patient and entered in the electronic data capture system. No site visits are required for this study, and patients will not be contacted for data collection outside of routine clinic visits.

For patients enrolled in the United States, a tokenization process (creation of a unique, encrypted identifier called a token, in place of personal identifiable information) will be used to collect additional de-identified data (e.g., healthcare resource use, healthcare costs) from other sources that are part of patients' routine medical care (electronic medical, hospital, or pharmacy records). Only de-identified data will be analyzed. Patients will be given a choice within the informed consent form to opt in or opt out of participating in the tokenization process.

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Osservativo

Iscrizione (Stimato)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
1850

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Contatto studio

Il nome e le informazioni di contatto della persona che può rispondere alle domande di iscrizione per uno studio clinico. Ogni sede in cui viene condotto lo studio può anche avere un contatto specifico, che potrebbe essere maggiormente in grado di rispondere a tali domande.

Luoghi di studio

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Reclutamento
        • Research Site
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Reclutamento
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3RIV9
        • Reclutamento
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Reclutamento
        • Research Site
      • Toronto, Ontario, Canada, M2J 4W8
        • Reclutamento
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Non ancora reclutamento
        • Research Site
      • Rimouski, Quebec, Canada, G5L 5T1
        • Non ancora reclutamento
        • Research Site
  • Cina
    • Anhui
      • Hefei, Anhui, Cina, 230001
        • Non ancora reclutamento
        • Research Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100191
        • Reclutamento
        • Research Site
      • Beijing, Beijing Municipality, Cina, 100730
        • Reclutamento
        • Research Site
      • Beijing, Beijing Municipality, Cina, 100034
        • Reclutamento
        • Research Site
      • Beijing, Beijing Municipality, Cina, 100029
        • Reclutamento
        • Research Site
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Cina, 400000
        • Reclutamento
        • Research Site
    • Fujian
      • Fuzhou, Fujian, Cina, 350005
        • Non ancora reclutamento
        • Research Site
      • Xiamen, Fujian, Cina, 361016
        • Reclutamento
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510515
        • Reclutamento
        • Research Site
      • Guangzhou, Guangdong, Cina, 510080
        • Reclutamento
        • Research Site
    • Guizhou
      • Guiyang, Guizhou, Cina, 550004
        • Non ancora reclutamento
        • Research Site
    • Hebei
      • Shijiazhuang, Hebei, Cina, 050000
        • Non ancora reclutamento
        • Research Site
    • Hubei
      • Wuhan, Hubei, Cina, 430000
        • Reclutamento
        • Research Site
      • Wuhan, Hubei, Cina, 430030
        • Reclutamento
        • Research Site
    • Hunan
      • Changsha, Hunan, Cina, 410013
        • Reclutamento
        • Research Site
      • Changsha, Hunan, Cina, 410011
        • Reclutamento
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210029
        • Reclutamento
        • Research Site
      • Suzhou, Jiangsu, Cina, 215006
        • Non ancora reclutamento
        • Research Site
    • Jiangxi
      • Nanchang, Jiangxi, Cina, 330000
        • Reclutamento
        • Research Site
    • Liaoning
      • Dalian, Liaoning, Cina, 116011
        • Non ancora reclutamento
        • Research Site
    • Shandong
      • Jinan, Shandong, Cina, 250012
        • Reclutamento
        • Research Site
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200040
        • Reclutamento
        • Research Site
      • Shanghai, Shanghai Municipality, Cina, 200025
        • Reclutamento
        • Research Site
      • Shanghai, Shanghai Municipality, Cina, 200031
        • Reclutamento
        • Research Site
    • Shanxi
      • Taiyuan, Shanxi, Cina, 030001
        • Non ancora reclutamento
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
        • Reclutamento
        • Research Site
      • Chengdu, Sichuan, Cina, 610072
        • Reclutamento
        • Research Site
    • Xi'An
      • Shaanxi, Xi'An, Cina, 710061
        • Reclutamento
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310009
        • Non ancora reclutamento
        • Research Site
  • Germania
      • Berlin, Germania, 10117
        • Reclutamento
        • Research Site
    • Bavaria
      • Würzburg, Bavaria, Germania, DE-97072
        • Non ancora reclutamento
        • Research Site
    • Hesse
      • Frankfurt am Main, Hesse, Germania, 60590
        • Reclutamento
        • Research Site
    • Lower Saxony
      • Hanover, Lower Saxony, Germania, 30625
        • Reclutamento
        • Research Site
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germania, 52074
        • Reclutamento
        • Research Site
      • Cologne, North Rhine-Westphalia, Germania, 50937
        • Reclutamento
        • Research Site
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germania, 55131
        • Reclutamento
        • Research Site
    • Saarland
      • Homburg, Saarland, Germania, 66421
        • Reclutamento
        • Research Site
  • Regno Unito
      • Glasgow, Regno Unito, G51 4TF
        • Reclutamento
        • Research Site
      • London, Regno Unito, NW3 2QG
        • Reclutamento
        • Research Site
    • West Midlands
      • Birmingham, West Midlands, Regno Unito, B15 2GW
        • Reclutamento
        • Research Site
  • Spagna
    • Andalusia
      • Huelva, Andalusia, Spagna, 21005
        • Reclutamento
        • Research Site
    • Basque Country
      • Bilbao, Basque Country, Spagna, 48013
        • Reclutamento
        • Research Site
    • Canary Islands
      • Las Palmas de Gran Canaria, Canary Islands, Spagna, 35010
        • Reclutamento
        • Research Site
    • Castille and León
      • Salamanca, Castille and León, Spagna, 37007
        • Reclutamento
        • Research Site
    • Catalu A
      • Barcelona, Catalu A, Spagna, 08035
        • Reclutamento
        • Research Site
      • Barcelona, Catalu A, Spagna, 8036
        • Non ancora reclutamento
        • Research Site
      • Cataluna, Catalu A, Spagna, 08907
        • Non ancora reclutamento
        • Research Site
    • Madrid
      • Majadahonda, Madrid, Spagna, 28222
        • Reclutamento
        • Research Site
    • Palma de Mallorca
      • Islas Baleares, Palma de Mallorca, Spagna, 07198
        • Reclutamento
        • Research Site
  • Stati Uniti
    • California
      • La Jolla, California, Stati Uniti, 92037
        • Reclutamento
        • Research Site
      • Los Angeles, California, Stati Uniti, 90095
        • Reclutamento
        • Research Site
      • San Francisco, California, Stati Uniti, 94143
        • Reclutamento
        • Research Site
      • San Francisco, California, Stati Uniti, 94025
        • Reclutamento
        • Research Site
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06510
        • Reclutamento
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, Stati Uniti, 20010
        • Reclutamento
        • Research Site
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • Reclutamento
        • Research Site
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 06200
        • Reclutamento
        • Research Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21218
        • Reclutamento
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02111
        • Reclutamento
        • Research Site
      • Boston, Massachusetts, Stati Uniti, 02114
        • Non ancora reclutamento
        • Research Site
      • Boston, Massachusetts, Stati Uniti, 02115
        • Reclutamento
        • Research Site
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Reclutamento
        • Research Site
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64111
        • Reclutamento
        • Research Site
      • St Louis, Missouri, Stati Uniti, 63110
        • Reclutamento
        • Research Site
    • New Jersey
      • New Brunswick, New Jersey, Stati Uniti, 08901
        • Reclutamento
        • Research Site
    • New York
      • Manhasset, New York, Stati Uniti, 11030
        • Reclutamento
        • Research Site
      • New York, New York, Stati Uniti, 10029
        • Reclutamento
        • Research Site
      • New York, New York, Stati Uniti, 10016
        • Non ancora reclutamento
        • Research Site
      • New York, New York, Stati Uniti, 10027
        • Reclutamento
        • Research Site
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Reclutamento
        • Research Site
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Reclutamento
        • Research Site
    • Pennsylvania
      • Danville, Pennsylvania, Stati Uniti, 17822
        • Reclutamento
        • Research Site
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Reclutamento
        • Research Site
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Reclutamento
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Stati Uniti, 29607
        • Reclutamento
        • Research Site
    • Tennessee
      • Germantown, Tennessee, Stati Uniti, 38138
        • Reclutamento
        • Research Site
      • Nashville, Tennessee, Stati Uniti, 037214
        • Reclutamento
        • Research Site
    • Texas
      • Dallas, Texas, Stati Uniti, 75246
        • Reclutamento
        • Research Site
      • Houston, Texas, Stati Uniti, 77030
        • Non ancora reclutamento
        • Research Site
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23298
        • Reclutamento
        • Research Site
    • Washington
      • Seattle, Washington, Stati Uniti, 98915
        • Reclutamento
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Reclutamento
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

Da 18 anni a 130 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with a diagnosis of amyloid transthyretin (ATTR) amyloidosis

Descrizione

Inclusion Criteria:

  • Patient willing and able to provide written informed consent to participate in the study
  • Confirmed diagnosis of amyloid transthyretin (ATTR) amyloidosis
  • Aged ≥18 years at the time of signing the informed consent
  • Patient willing and able to participate in collection of electronic patient reported outcomes (PROs)

Exclusion Criteria:

  • Concurrent participation in any interventional trial for ATTR amyloidosis
  • Involvement in the planning and/or conduct of the current study
  • Patients with evidence of primary or light chain amyloidosis (AL) or serum protein A amyloidosis (AA)
  • Asymptomatic patients with ATTR amyloidosis and asymptomatic ATTR mutation carriers

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte

Gruppo / Coorte

Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
ATTR cardiomyopathy (ATTR-CM)

Patients with ATTR-CM at enrollment
Droga: Treatment of transthyretin (ATTR) amyloidosis in observational study setting

Data will be collected on patients with ATTR amyloidosis in a real-world setting
Hereditary polyneuropathy (ATTRv-PN)

Patients with ATTRv-PN at enrollment
Droga: Treatment of transthyretin (ATTR) amyloidosis in observational study setting

Data will be collected on patients with ATTR amyloidosis in a real-world setting
ATTR-Mixed

Patients with a mixed ATTR amyloidosis phenotype
Droga: Treatment of transthyretin (ATTR) amyloidosis in observational study setting

Data will be collected on patients with ATTR amyloidosis in a real-world setting

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Demographic characteristics (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years
  • Age
  • Sex as determined by the investigator (male/female)
  • Race and ethnicity, where allowed
From time of enrollment for up to 7 years
Treatment patterns (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following treatments will be assessed:

  • ATTR amyloidosis treatment: Tafamidis, Diflunisal, Acoramidis, Vutrisiran, Patisiran, Inotersen, Eplontersen, Doxycycline and taurodesoxycholic acid, Liver transplant
  • Heart failure/arrhythmia-related treatment: Diuretics, Angiotensin converting enzyme inhibitor, Angiotensin receptor blocker, Angiotensin receptor-neprilysin inhibitor, Anticoagulation, Beta-blockers, Sodium-glucose co-transporter-2 inhibitor, Mineralocorticoid receptor antagonist, Digoxin, Pacemaker use, Implantable cardioverter-defibrillator, Left ventricular assist device, Cardiac transplant, Transcatheter aortic valve replacement, Surgical aortic valve replacement
  • Polyneuropathy-related treatment: Antiepileptics (gabapentin, pregabalin, carbamazepine, phenytoin), Antidepressants, Topical pain treatments, Opioids, Tetrahydrocannabinol
  • Other: Medications for gastrointestinal symptoms, Vitamin A supplementation, Dialysis
From time of enrollment for up to 7 years
Clinical characteristics (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following clinical characteristics will be assessed:

  • Modified body mass index (mBMI)
  • Medical history
  • TTR genetic test results
  • Family history of ATTR
  • Time period between the first symptoms to date of diagnosis of ATTR
  • Time since diagnosis of ATTR
From time of enrollment for up to 7 years
Findings from biopsy (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following biopsy information will be collected:

  • Type of biopsy
  • Amyloid identification result (Positive, Negative, Inconclusive for amyloid)
  • Method of amyloid typing
  • Result of the biopsy (Normal/Abnormal)
  • Reason for considering the biopsy result abnormal
From time of enrollment for up to 7 years
Findings from Cardiovascular magnetic resonance imaging (CMR) (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following information will be collected: extracellular volume (ECV), contrast use, left ventricular (LV) end-diastolic volume, LV end-systolic volume, LV ejection fraction, LV Mass Index, interventricular wall thickness, right ventricular Free Wall Thickness, LV Free Wall Thickness, left Atrial Volume Index, native T1 mapping, CMR result (Normal/Abnormal), reason for considering the result abnormal.
From time of enrollment for up to 7 years
Findings from Bone tracer cardiac scintigraphy (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following information will be collected: Type of tracer, Heart to contralateral lung ratio (H/CL), Perugini grade, scintigraphy result (Normal/Abnormal), reason for considering the result abnormal.
From time of enrollment for up to 7 years
Findings from Echocardiography (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following information will be collected: LV ejection fraction, LV End Diastolic Volume, LV End Systolic Volume LV End Diastolic Dimension, LV End Systolic Dimension, Interventricular Septal Thickness End Diastole, Posterial Wall Thickness End Diastole, Left Ventricular Mass Index, Left Atrial Volume, Left Atrial Volume Index, Mitral valve regurgitation, Aortic valve regurgitation, Tricuspid valve regurgitation, Pulmonic valve regurgitation, LV Outflow Gradient, Stroke Volume, Lateral early diastolic myocardial velocity (e' lateral), Medial early diastolic myocardial velocity (e' medial), Mitral E/e' Ratio, Early diastolic mitral inflow velocity (E), Late diastolic mitral inflow velocity (A), Mitral Peak E/A Ratio, Global LV longitudinal strain, Pulmonary artery systolic pressure, RV Free Wall Thickness Severity of Aortic stenosis, Severity of Mitral stenosis.
From time of enrollment for up to 7 years
ECG variables (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following ECG information will be collected:

  • Interpretation of the ECG (Normal/Abnormal/Borderline)
  • Heart rhythm
  • Presence of extrasystoles
  • Presence of conduction abnormalities
  • Evidence of left ventricular hypertrophy (LVH)
From time of enrollment for up to 7 years
Sural nerve and tibial nerve amplitude (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

Sural nerve and tibial nerve amplitude will be measured in overall and in patients initiating a treatment with eplontersen
From time of enrollment for up to 7 years
Biomarker results (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following biomarker results will be collected:

  • Serum TTR levels
  • Complete blood count
  • Hemoglobin
  • Troponin I
  • Cystatin
  • Creatinine
  • Reported glomerular filtration rate (GFR)
  • Albumin
  • Liver enzymes: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), total bilirubin
  • N-terminal pro B-type natriuretic peptide (NT-proBNP)
  • Vitamin A level
  • Neurofilament light chain (NfL)
  • International normalized ratio (INR) test
From time of enrollment for up to 7 years
Urine test results (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following test results will be collected:

  • Urine albumin-creatinine ratio (UACR)
  • Urine protein creatinine ratio (UPCR)
From time of enrollment for up to 7 years
Clinical manifestations (signs and symptoms) of ATTR amyloidosis (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following clinical manifestations will be assessed:

ischemic heart disease, acute myocardial infarction, heart failure, atrial fibrillation, arrhythmias, conduction system disease, aortic valve stenosis polyneuropathy, carpal tunnel syndrome, autonomic neuropathy, nephrotic syndrome, subnephrotic proteinuria, gastrointestinal dysfunction, chronic kidney disease / acute kidney injury, spinal stenosis, spinal stenosis surgery, hepatomegaly, ascites, oedema, other amyloidosis related manifestations (e.g., Popeye's sign, tendon rupture)
From time of enrollment for up to 7 years
36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary score (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

The SF-36v2 is a 36-item, generic health survey that provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) and two summary scores; the physical component summary (PCS) score and the mental component summary (MCS) score. Higher scores indicate a better health state.
From time of enrollment for up to 7 years
Norfolk Quality of Life-Diabetic Neuropathy total score (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

The Norfolk QOL-DN is a 35-item, disease-specific instrument that provides scores for five domains (symptoms, large fiber neuropathy, small fiber neuropathy, autonomic neuropathy, and activities of daily living) and a total score. Higher scores indicate a worse health state.
From time of enrollment for up to 7 years
Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

The KCCQ is a 23-item, disease-specific questionnaire that assesses seven domains (physical limitations, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation) and provides three summary scores (total symptom score, clinical summary score, and overall summary score). Higher scores indicate a better health state.
From time of enrollment for up to 7 years
New York Heart Association (NYHA) classification (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

I=No symptoms; II=Symptoms with ordinary physical activity; III=Symptoms with less than ordinary physical activity; IV=Symptoms at rest.
From time of enrollment for up to 7 years
National Amyloidosis Centre (NAC) ATTR staging or Mayo staging (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

For NAC staging, Stage I: N-terminal pro-brain natriuretic peptide (NT-proBNP) ≤3000 ng/L and estimated glomerular filtration rate (eGFR) ≥45 ml/min; Stage III: NT-proBNP >3000 ng/L and eGFR <45 ml/min; Stage IV:NT-proBNP ≥10,000 ng/L; Stage II: remainder of patients

For Mayo staging, Stage I: Both and biomarker values are below the established thresholds; Stage II: Either troponin T or NT-proBNP is above the threshold; Stage III: Both troponin T and NT-proBNP biomarker values are above the threshold.

Biomarker Thresholds: Troponin T: >0.05 mg/mL and NT-proBNP: >3000 pg/mL.
From time of enrollment for up to 7 years
Familial amyloid polyneuropathy (FAP) (Coutinho) staging (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

Stage 0: No symptoms; Stage I: Unimpaired ambulation; mostly mild sensory, motor and autonomic neuropathy in the lower limbs; Stage II: Assistance with ambulation required, mostly moderate impairment progression to the lower limbs, upper limbs, and trunk; Stage III: Wheelchair-bound or bedridden; severe sensory, motor, and autonomic involvement of all limbs.
From time of enrollment for up to 7 years
Polyneuropathy disability (PND) score (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

Stage 0=No symptoms; Stage I=Sensory disturbances but preserved walking capabilities; Stage II=Impaired walking capacity, but ability to walk without a stick or crutches; Stage IIIA=Walking with help of 1 stick or crutch; Stage IIIB=Walking with the help of 2 sticks or crutches; Stage IV=confined to wheel chair or bedridden.
From time of enrollment for up to 7 years
Left Ventricular Ejection Fraction (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

Left Ventricular Ejection Fraction will be measured in overall and in patients initiating a treatment with eplontersen
From time of enrollment for up to 7 years
6-minute walk test (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

To address this objective, the distance walked in 6 minutes will be measured.
From time of enrollment for up to 7 years
Charlson comorbidity index (CCI) and CCI components (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address CCI, most recent score and all CCI componenet will be measured

  • Myocardial infarction
  • Congestive heart failure
  • Peripheral vascular disease
  • Cerebrovascular disease
  • Dementia
  • Chronic pulmonary disease
  • Rheumatic disease
  • Peptic ulcer disease
  • Diabetes (None, Without chronic complications, With chronic complications)
  • Hemiplegia or paraplegia
  • Renal disease
  • Any malignancy, including lymphoma and leukemia, except malignant neoplasm of skin (None, Localized, Metastatic)
  • Liver disease (None, Mild, Moderate, Severe)
  • Metastatic solid tumor
  • Acquired immune deficiency syndrome (AIDS) / Human immunodeficiency virus (HIV)
From time of enrollment for up to 7 years
Other comorbidities of interest (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following information will be collected:

  • Percentage of patients with depression
  • Percentage of patients with fibromyalgia
  • Percentage of patients with paraproteinemia
From time of enrollment for up to 7 years
Healthcare resource utilization (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: From time of enrollment for up to 7 years

In order to address this objective, the following information will be collected:

  • Number of emergency department visits
  • Number of outpatient visits
  • Inpatient care/hospitalization general ward (non-intensive): number of inpatient stays, number of bed days
  • Inpatient care/hospitalization intensive ward: number of inpatient stays, number of bed days
From time of enrollment for up to 7 years
Mortality (overall and in patients initiating a treatment with eplontersen)
Lasso di tempo: Throughout study follow-up (up to 7 years)

Mortality during study follow-up (all-cause, related to ATTR amyloidosis), overall and by NYHA/NAC or Mayo/FAP stage
Throughout study follow-up (up to 7 years)
Liver Disease and Live Transplant
Lasso di tempo: From time of Enrollment for up to 7 Years
  • Liver disease (for patients with mild, moderate or severe liver disease: Child Pugh score, Child Pugh class, ascites, encephalopathy)
  • Liver transplantation (reason for transplant, type of transplant)
From time of Enrollment for up to 7 Years

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
Comparison of demographic and clinical characteristics of patients prescribed eplontersen at any time during the observation period to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments:

  • Demographics
  • mBMI
  • Medical history
  • Family history of ATTR amyloidosis
  • Time period between the first symptoms to date of diagnosis of ATTR amyloidosis
  • Time since diagnosis of ATTR amyloidosis
Up to 7 years
Comparison of findings from biopsy in patients prescribed eplontersen at any time during the observation period to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments:

  • Type of biopsy
  • Amyloid identification result (Positive, Negative, Inconclusive for amyloid)
  • Method of amyloid typing
  • Result of the biopsy (Normal/Abnormal)
  • Reason for considering the biopsy result abnormal
Up to 7 years
Comparison of findings from Cardiovascular magnetic resonance imaging (CMR) in patients prescribed eplontersen at any time during the observation period to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments: extracellular volume (ECV), contrast use, left ventricular (LV) end-diastolic volume, LV end-systolic volume, LV ejection fraction, LV Mass Index, interventricular wall thickness, right ventricular Free Wall Thickness, LV Free Wall Thickness, left Atrial Volume Index, native T1 mapping, CMR result (Normal/Abnormal), reason for considering the result abnormal.
Up to 7 years
Comparison of findings from Echocardiography in patients prescribed eplontersen at any time during the observation period to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments: LV ejection fraction, LV End Diastolic Volume, LV End Systolic Volume LV End Diastolic Dimension, LV End Systolic Dimension, Interventricular Septal, Thickness Diastole, Posterial Wall Thickness Diastole, Left Ventricular Mass Index, Left Atrial Volume, Left Atrial Volume Index, Mitral valve regurgitation, Aortic valve regurgitation, Tricuspid valve regurgitation, Pulmonic valve regurgitation, LV Outflow Gradient, Stroke Volume, Lateral early diastolic myocardial velocity (e' lateral), Medial early diastolic myocardial velocity (e' medial), Mitral E/e' Ratio, Early diastolic mitral inflow velocity (E), Late diastolic mitral inflow velocity (A), Mitral Peak E/A Ratio, Global LV longitudinal strain, Pulmonary artery systolic pressure, RV Free Wall Thickness Severity of Aortic stenosis, Severity of Mitral stenosis.
Up to 7 years
Comparison of ECG variables of patients prescribed eplontersen at any time during the observation period to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments:

  • Interpretation of the ECG (Normal/Abnormal/Borderline)
  • Heart rhythm
  • Presence of extrasystoles
  • Presence of conduction abnormalities
  • Evidence of left ventricular hypertrophy (LVH)
Up to 7 years
Comparison of findings from Bone tracer cardiac scintigraphyin patients prescribed eplontersen at any time during the observation period to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments: Type of tracer, Heart to contralateral lung ratio (H/CL), Perugini grade, scintigraphy result (Normal/Abnormal), reason for considering the result abnormal.
Up to 7 years
Comparison of sural nerve and tibial nerve amplitude in patients prescribed eplontersen at any time during the observation eriod to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

Sural nerve and tibial nerve amplitude will be compared in patients prescribed eplontersen at any time during the observation period to patients on other ATTR treatments
Up to 7 years
Comparison of biomarker results in patients prescribed eplontersen at any time during the observation eriod to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments:

  • Serum TTR levels
  • Complete blood count
  • Hemoglobin
  • Troponin I
  • Cystatin
  • Creatinine
  • Reported glomerular filtration rate (GFR)
  • Albumin
  • Liver enzymes: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), total bilirubin
  • N-terminal pro B-type natriuretic peptide (NT-proBNP)
  • Vitamin A level
  • Neurofilament light chain (NfL)
  • International normalized ratio (INR) test
Up to 7 years
Comparison of urine test results in patients prescribed eplontersen at any time during the observation eriod to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments:

  • Urine albumin-creatinine ratio (UACR)
  • Urine protein creatinine ratio (UPCR)
Up to 7 years
Comparison of Clinical manifestations (signs and symptoms) of ATTR amyloidosis in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments: ischemic heart disease, acute myocardial infarction, heart failure, atrial fibrillation, arrhythmias, conduction system disease, aortic valve stenosis polyneuropathy, carpal tunnel syndrome, autonomic neuropathy, nephrotic syndrome, subnephrotic proteinuria, gastrointestinal dysfunction, chronic kidney disease / acute kidney injury, spinal stenosis, spinal stenosis surgery, hepatomegaly, ascites, oedema, other amyloidosis related manifestations (e.g., Popeye's sign, tendon rupture)
Up to 7 years
Comparison of 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary score in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

SF-36v2, physical component summary scores will be compared between patients treated with eplontersen and patients on other ATTR treatments.
Up to 7 years
Comparison of Norfolk Quality of Life-Diabetic Neuropathy total score in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

Norfolk Quality of Life-Diabetic Neuropathy total scores will be compared between patients treated with eplontersen and patients on other ATTR treatments.
Up to 7 years
Comparison of Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score will be compared in patients prescribed eplontersen to patients on other ATTR treatments
Up to 7 years
Comparison of New York Heart Association (NYHA) classification in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

New York Heart Association (NYHA) classification will be compared in patients prescribed eplontersen to patients on other ATTR treatments
Up to 7 years
Comparison of Familial amyloid polyneuropathy (FAP) (Coutinho) staging in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

FAP staging:

Stage 0: No symptoms; Stage I: Unimpaired ambulation; mostly mild sensory, motor and autonomic neuropathy in the lower limbs; Stage II: Assistance with ambulation required, mostly moderate impairment progression to the lower limbs, upper limbs, and trunk; Stage III: Wheelchair-bound or bedridden; severe sensory, motor, and autonomic involvement of all limbs.
Up to 7 years
Comparison of Left Ventricular Ejection Fraction in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

Left Ventricular Ejection Fraction will be compared in patients prescribed eplontersen to patients on other ATTR treatments
Up to 7 years
Comparison of Charlson comorbidity index (CCI) and CCI components in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

Charlson comorbidity index (CCI) and CCI components will be compared in patients prescribed eplontersen to patients on other ATTR treatments
Up to 7 years
Comparison of other comorbidities of interest in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments:

  • Percentage of patients with depression
  • Percentage of patients with fibromyalgia
  • Percentage of patients with paraproteinemia
Up to 7 years
Comparison of healthcare resource utilization in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

The following outcomes will be compared between patients treated with eplontersen and patients on other ATTR treatments:

  • Number of emergency department visits
  • Number of outpatient visits
  • Inpatient care/hospitalization general ward (non-intensive): number of inpatient stays, number of bed days
  • Inpatient care/hospitalization intensive ward: number of inpatient stays, number of bed days
Up to 7 years
Comparison of mortality in patients prescribed eplontersen to patients on other ATTR treatments
Lasso di tempo: Up to 7 years

Mortality will be compared in patients prescribed eplontersen to patients on other ATTR treatments
Up to 7 years

Altre misure di risultato

Altre misure di risultato

Per gli studi clinici, una misurazione pianificata descritta nel protocollo utilizzata per determinare l'effetto di un intervento/trattamento sui partecipanti. Per gli studi osservazionali, una misurazione o un'osservazione utilizzata per descrivere modelli di malattie o tratti o associazioni con esposizioni, fattori di rischio o trattamento. I tipi di misure di esito includono la misura dell'esito primario e la misura dell'esito secondario.
Misura del risultato
Misura Descrizione
Lasso di tempo
Risk factors for worsening ATTR progression
Lasso di tempo: up to 7 years

Factors associated with changes in clinical manifestations of ATTR amyloidosis, NYHA classification, NAC ATTR staging or Mayo staging, FAP (Coutinho) staging, PND score, LVEF, CCI and CCI components, and other comorbidities of interest will be identified.
up to 7 years
Healthcare costs in patients with ATTR amyloidosis
Lasso di tempo: Up to 7 years

Average annual costs will be calculated based on available data in the different countries.
Up to 7 years
Serious adverse events in patients treated with ATTR amyloidosis treatments
Lasso di tempo: Up to 7 years

Serious adverse events in patients treated with ATTR amyloidosis treatments will be measured
Up to 7 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
AstraZeneca

Collaboratori

Collaboratori

Un'organizzazione diversa dallo sponsor che fornisce supporto per uno studio clinico. Questo supporto può includere attività relative al finanziamento, alla progettazione, all'implementazione, all'analisi dei dati o al reporting.
ICON plc

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
25 giugno 2024

Completamento primario (Stimato)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
31 dicembre 2031

Completamento dello studio (Stimato)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
31 dicembre 2031

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
13 maggio 2024

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
13 giugno 2024

Primo Inserito (Effettivo)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
20 giugno 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
23 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
22 settembre 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • D8450R00003

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Plan to share only the redacted CSR synopsis

Periodo di condivisione IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criteri di accesso alla condivisione IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Tipo di informazioni di supporto alla condivisione IPD

  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Impostazioni dei cookie

Utilizziamo i cookie per assicurarci di darti la migliore esperienza sul nostro sito web. Per maggiori dettagli leggi attentamente la nostra Informativa sulla privacy e sui cookie. ...>>>Puoi modificare le tue preferenze o revocare il tuo consenso in qualsiasi momento eliminando i cookie dal tuo sito web o computer come descritto nella policy. Accettalo e scegli le tue preferenze spuntando le caselle corrispondenti nella sezione "Gestisci impostazioni" di seguito. Leggi attentamente i nostri Termini di servizio prima di procedere con l'utilizzo di qualsiasi parte di questo sito web.
«Gestisci impostazioni