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Набор скоро начнётся NCT06579313

Current Situation of Health Care in Women With HBV or HCV Infection

— Наблюдательное HBV HCV

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: HBV, HCV. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

A multicenter, retrospective study conducted in male and female population infected with HBV or HCV in east China. HCV part, study will enroll 500 HCV antibody positive and HCV RNA positive patients during 2020.7-2023.12 and then observe the characteristics, duration from diagnosis to treatment, treatment rate and sustained virologic response (SVR12) among eligible female and male patients. HBV part, study will enroll 2000 HBsAg positive patients during 2016.7-2019.12 and then observe the clinical characteristics, natural history, duration from diagnosis to treatment, treatment rate and adherence among eligible female and male patients.

Подробное описание

Some of the sociocultural factors may prevent women infected with HBV or HCV benefiting from quality health care. Limited articles have ever reported the situation of health care in women with viral hepatitis. A previous study found that low HCV knowledge was observed in females, which was related to a lower willingness to be treated for HCV. Besides that, in other disease areas like hypertension, studies found that females have less awareness of their disease but have higher control over it compared with males. These findings might reflect the differences in health literacy levels which might influence disease outcomes, healthcare-seeking and adherence to treatment. This research aims to fill the data gaps of the gender differences in cascade of care in HBV and HCV, to facilitate patient activation, especially for women.

So far, data on the current health care status in HBV-infected women is scarce. With the expansion of treatment indications recommended by China CHB guidelines, more female patients will have the opportunity to gain timely and necessary treatment. This study will analyze the cascade of care by observing the duration from diagnosis to treatment and treatment adherence for women. And this knowledge will serve as a guide for interventions for the management of viral hepatitis, as well as effectively finding and activating patients who meet treatment criteria but are not being treated.

Первичные конечные точки

  • Treatment Rate in male in HBV cohort [Срок оценки: from July 2020 to December 2023]
  • Treatment Rate in female in HBV cohort [Срок оценки: from July 2020 to December 2023]
  • Treatment Rate in male in HCV cohort [Срок оценки: from July 2016 to December 2019]
  • Treatment Rate in female in HCV cohort [Срок оценки: from July 2016 to December 2019]
Вторичные конечные точки (4)
  • Distribution of Income levels among male in HBV cohort [Срок оценки: from July 2020 to December 2023]
  • Distribution of Income levels among female in HBV cohort [Срок оценки: from July 2020 to December 2023]
  • Distribution of medical insurance type in male in HCV cohort [Срок оценки: from July 2016 to December 2019]
  • Distribution of medical insurance type in female in HCV cohort [Срок оценки: from July 2016 to December 2019]

Критерии участия

Критерии включения

HBV Cohort -

  • ≥18 years old
  • serum HBsAg positive for >6 months
  • Treatment naïve or,
  • Patients who had been previously treated for HBV but discontinued for at least 1 year before enrollment

HCV Cohort -

  • ≥18 years old
  • HCV-Ab positive
  • HCV RNA positive
  • Treatment naïve or,
  • Patients who had been previously treated for HCV with a regimen containing interferon and not had a sustained virologic response.

Критерии исключения

  • HBV/HCV Co-infection
  • HIV
  • History of hepatic decompensation or hepatocellular carcinoma
  • Other carcinoma
  • Other severe liver disease
  • Severe Comorbidity like cardiovascular disease, diabetes etc.
  • Patients who had discontinued previous HCV treatment because of an adverse event.
  • Patients who had previously received any nucleotide analogue HCV NS5B inhibitor or any NS5A inhibitor
  • Patients who had discontinued previous HBV treatment because of an adverse event.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06579313 · IN-US-987-7219

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗