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Набор скоро начнётся NCT05451082

Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China

— Наблюдательное Hepatitis D

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: Hepatitis D. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a retrospective, prospective, noninterventive, multicenter registry study. Patients diagnosed with HDV infection (based on positive HDV RNA) were included in this study and were followed up for at least 5 years to evaluate their disease progression and clinical outcomes (including death, liver transplantation, hepatocellular carcinoma \[hcc\], liver decompensation, and cirrhosis) during the 5-year follow-up period. All patients were followed up at least once a year after they were included in the study. It was in 2016 HDV infection first reported in China. Since January 1, 2016, all patients diagnosed with HDV infection can be enrolled in this study and evidence confirming the diagnosis (including but not limited to HDV RNA test reports and medical records, etc.) must be delivered. The main test results (including serum HDV RNA, ALT, and tests to determine the presence of liver cirrhosis, decompensation of liver function, and liver cancer such as B-ultrasound and FibroScan) of these patients each year from diagnosis to enrollment should be collected and filled in the case report form (CRF). Follow-up data of patients with serum anti-HDV positive and HDV RNA negative can be recorded and followed up on this platform, with informed consent of the patients is required. Patients whose serum HBV RNA turn positive during the follow-up period will be included in the follow-up cohort of the study.

Первичные конечные точки

  • The incidence of death of patients infected with HDV during 5-year follow-up [Срок оценки: 5 years]
  • The incidence of liver transplantation of patients infected with HDV during 5-year follow-up [Срок оценки: 5 years]
  • The incidence of hepatocellular carcinoma of patients infected with HDV during 5-year follow-up [Срок оценки: 5 years]
  • The incidence of liver decompensation of patients infected with HDV during 5-year follow-up [Срок оценки: 5 years]
  • The incidence of cirrhosis of patients infected with HDV during 5-year follow-up [Срок оценки: 5 years]
Вторичные конечные точки (12)
  • Demographic characteristics of HDV-infected individuals using baseline data [Срок оценки: 1 year]
  • Epidemiological characteristics of HDV-infected individuals using baseline data [Срок оценки: 1 year]
  • Serum HDV RNA levels of patients infected with HDV [Срок оценки: 5 years]
  • Serum HBV DNA levels of patients infected with HDV [Срок оценки: 5 years]
  • HBsAg concentration levels of patients infected with HDV [Срок оценки: 5 years]
  • Serum alanine aminotransferase concentration levels of patients infected with HDV [Срок оценки: 5 years]
  • Serum total bilirubin concentration levels of patients infected with HDV [Срок оценки: 5 years]
  • Serum albumin levels concentration levels of patients infected with HDV [Срок оценки: 5 years]
  • Child-Pugh scores of patients infected with HDV [Срок оценки: 5 years]
  • The incidence of death of chronic HDV-infected patients with persistently normal ALT [Срок оценки: 5 years]
  • The incidence of liver transplantation of chronic HDV-infected patients with persistently normal ALT [Срок оценки: 5 years]
  • The incidence of hepatocellular carcinoma (HCC) of chronic HDV-infected patients with persistently normal ALT [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Adults aged 18 or above, both sex;
  • Evidence of a positive test for HDV RNA can be provided on or before the enrollment date;
  • Able to sign written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Bejing Tsinghua Changgung Hospital — Пекин

Публикации

  • Lok AS, Negro F, Asselah T, Farci P, Rizzetto M. Endpoints and New Options for Treatment of Chronic Hepatitis D. Hepatology. 2021 Dec;74(6):3479-3485. doi: 10.1002/hep.32082. Epub 2021 Sep 16. No abstract available. PMID 34331781
  • Rizzetto M, Hamid S, Negro F. The changing context of hepatitis D. J Hepatol. 2021 May;74(5):1200-1211. doi: 10.1016/j.jhep.2021.01.014. Epub 2021 Jan 20. PMID 33484770

Идентификаторы

NCT: NCT05451082 · 22201-4-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗