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Набор скоро начнётся NCT07007286

Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer

— Наблюдательное HBV HCC

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
В протоколе указаны: ETV,TDF,TAF,TMF combination with PEG IFNα-2b, ETV,TDF,TAF or TMF.
Кому может быть актуально
Состояния в реестре: HBV, HCC. Базовые параметры: от 30 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
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Официальное название

A Real-World Study on Reducing the Risk of Liver Cancer in Chronic Hepatitis B Patients With a Family History of HBV-Related Liver Cancer.

Обзор

This study is a prospective, multicenter, real-world cohort study designed to compare the long-term outcomes of chronic hepatitis B patients with a family history of HBV-related hepatocellular carcinoma (HCC) who receive PEG IFNα-2b combined with nucleos(t)ide analogues or nucleos(t)ide monotherapy. The primary endpoint is the incidence rate of HCC, and secondary endpoints include the rate of HBsAg seroclearance, changes in liver fibrosis, and survival rates. The study will last for 5 years and enroll approximately 15,000 patients, aiming to provide evidence-based optimization for CHB treatment regimens.

Вмешательства

  • Препарат ETV,TDF,TAF,TMF combination with PEG IFNα-2b
    The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.
  • Препарат ETV,TDF,TAF or TMF
    The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.

Первичные конечные точки

  • 5-year incidence of hepatocellular carcinoma (HCC) [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
Вторичные конечные точки (10)
  • HBsAg seroclearance rate [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
  • HBeAg seroclearance rate [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
  • HBV DNA level [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
  • HBsAg level [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
  • HBeAg level [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
  • Proportion of patients with improved or progressed liver fibrosis [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
  • Median time to cirrhosis [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
  • Median time to decompensated cirrhosis [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
  • Median time to HCC [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]
  • Overall survival (OS) [Срок оценки: From the start of antiviral treatment to 5 years of follow-up.]

Критерии участия

Критерии включения

  • (1) Chronic hepatitis B (CHB) patients with HBsAg positivity for over 6 months; (2) Family history of HBV-related hepatocellular carcinoma (HCC) (first- or second-degree relatives with HBV-related HCC); (3) Age ≥ 30 years, regardless of gender; (4) Based on real-world clinical practice, patients receiving nucleos(t)ide analogue (NA) therapy, such as Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide Fumarate (TAF), or Tenofovir Amibufenamide (TMF), or those receiving combination therapy with nucleos(t)ide analogues and PEG IFNα-2b; (5) Negative pregnancy test within 24 hours before the first dose (for women of childbearing potential); (6) Voluntary participation, with the ability to understand and sign the informed consent form.

Критерии исключения

  • (1) Patients diagnosed with hepatocellular carcinoma (HCC) or malignancies in other organ systems prior to treatment; (2) Patients with contraindications to Peg IFN α-2b (refer to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) for details); (3) Patients in the immune-tolerant phase of HBV infection; (4) Patients scheduled for or with a history of organ transplantation; (5) Patients with hypersensitivity to interferon or any contraindication listed in the drug's prescribing information; (6) Other conditions deemed unsuitable for enrollment by the investigator.

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 · 555 центров
  • Qitaihe Infectious Disease Hospital — Heilongjiang
  • Yizheng People's Hospital — Yizheng
  • Changle County People's Hospital — Changle
  • Juxian People's Hospital — Junxian
  • Pingdu People's Hospital, Shandong — Pingdu
  • Zouping People's Hospital — Zouping
  • Huozhou Coal & Electricity Group General Hospital Co., Ltd. — Huozhou
  • Huozhou People's Hospital, Huozhou Medical Group — Huozhou
  • … и ещё 547 центров

Идентификаторы

NCT: NCT07007286 · 2025086

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗