Набор скоро начнётся NCT07727187

Hepatitis B Infection Surveillance

— Наблюдательное Chronic Hepatitis B Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Chronic Hepatitis B Infection. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

National Surveillance of Patients With Chronic Hepatitis B (±D) From Expert/Reference Hepatology Centers (FPRH), Hepatology Departments in General Hospitals (ANGH), and the Virology and Medical Pharmacology Network (ANRS-MIE)

Обзор

France is a low-endemicity country for hepatitis B virus (HBV) infection. In 2016, the prevalence of chronic HBV infection in the general population was estimated at 0.3%, corresponding to more than 135,000 HBsAg-positive individuals, of whom 82% were unaware of their infection. Data on hepatitis D virus (HDV) infection remain limited; however, available studies suggest a prevalence of 6% to 10% among HBsAg-positive individuals. Despite current guideline recommendations, up to 35% of newly diagnosed HBsAg-positive patients between 2018 and 2022 were not screened for HDV infection. The World Health Organization (WHO) targets for 2030 include a 90% reduction in the incidence of chronic viral hepatitis, a 65% reduction in hepatitis-related mortality, and treatment coverage for 80% of eligible diagnosed individuals. Achieving these goals will require strengthening HBV and HDV screening strategies and improving linkage to care and retention throughout the care cascade. Objectives: The primary objective is to assess the severity of liver disease, including significant fibrosis (≥F2) and cirrhosis (F4), among adults newly diagnosed with chronic HBV infection (with or without HDV infection) at Expert/Reference Hepatology Centers and Hepatology or Infectious Diseases Departments. The secondary objectives are to: 1. Describe demographic and virological characteristics of HBsAg-positive patients; 2. Determine the proportion of patients eligible for HBV treatment and evaluate treatment response at 6 and 12 months; 3. Assess the utility of novel virological markers for classifying patients according to phases of chronic HBV infection; 4. Evaluate HBsAg thresholds, in combination with other markers, for distinguishing HBeAg-negative chronic infection from HBeAg-negative chronic hepatitis; 5. Compare clinical and virological characteristics of HBV-monoinfected and HBV/HDV-coinfected patients; 6. Identify molecular signatures associated with liver disease severity; 7. Compare findings with those of a national cohort conducted 15 years earlier; 8. Collect biological samples for future analyses; 9. Assess the clinical utility of a highly sensitive HBcrAg assay. Method: This is a multicenter, observational study including all adults aged ≥18 years with chronic HBV infection, whether managed as outpatients or inpatients, who are newly referred to Expert/Reference Hepatology Centers or to Hepatology or Infectious Diseases Departments. Conclusions: This study will generate updated national data on liver disease severity, treatment eligibility, and virological characteristics among adults newly diagnosed with chronic HBV infection in France.

Первичные конечные точки

Proportion of patients with significant fibrosis (METAVIR score ≥F2), including cirrhosis (METAVIR score F4) [Срок оценки: Baseline (at inclusion)]

Вторичные конечные точки (10)

Demographic characteristics of newly identified chronic HBsAg carriers [Срок оценки: Baseline (at inclusion)]
Virological characteristics of newly identified chronic HBsAg carriers [Срок оценки: Baseline (at inclusion)]
Antiviral treatment eligibility and response [Срок оценки: Baseline (at inclusion), 6 months and 12 months]
Performance of novel virological markers (HBcrAg level and HBV RNA level) in identifying patients at risk of disease progression [Срок оценки: Baseline (at inclusion)]
Diagnostic performance of HBsAg thresholds, in combination with other virological markers for distinguishing HBeAg-negative chronic HBV infection from HBeAg-negative chronic hepatitis B [Срок оценки: Baseline (at inclusion)]
Characteristics of HDV infection [Срок оценки: Baseline (at inclusion)]
Genome sequence analysis and identification of HBV motifs associated with the severity of liver disease in HBV/HDV-coinfected patients [Срок оценки: Baseline (at inclusion)]
Comparison with previous French cohort data (2008-2012) [Срок оценки: Baseline (at inclusion)]
Biobank collection [Срок оценки: Baseline (at inclusion)]
Clinical performance of ultra-sensitive HBcrAg assay (iTACT-HBcrAg) [Срок оценки: Baseline (at inclusion)]

Критерии участия

Критерии включения

Age 18 years or older
Chronic HBsAg carriage
First referral to participating expert/reference hepatology centers or hepatology/infectious diseases departments
Written informed consent obtained
Affiliation with national health insurance system or equivalent coverage