Идёт набор NCT03792919

Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)

Фаза IV С лечением Chronic Hepatitis B

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: Stop current treatment (anti-HBV neucleos(t)ides), Keep current treatment (anti-HBV neucleos(t)ides).
Кому может быть актуально: Состояния в реестре: Chronic Hepatitis B. Базовые параметры: Без ограничений · 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: Гонконг
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

Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients

Обзор

To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB) patients.

Подробное описание

Nucleos(t)ides analogues(NAs) is a safe and effective treatment among chronic hepatitis B(CHB) patients with excellent tolerance. Entecavir or tenofovir mono therapy has been shown to achieve inhibition of HBV replication in almost all adherent patients. However, HBsAg loss rate is low even after long-term NAs treatment. Recent studies indicated that cessation of NAs treatment could increase HBsAg clearance rate. Identifying the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance is very important.

Вмешательства

Препарат Stop current treatment (anti-HBV neucleos(t)ides)
Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
Препарат Keep current treatment (anti-HBV neucleos(t)ides)
Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.

Первичные конечные точки

Incidence of HBsAg clearance [Срок оценки: From baseline to the end of the fifth year after cessation of anti-HBV treatment.]

Вторичные конечные точки (5)

Incidence of HBsAg seroconversion [Срок оценки: From baseline to the end of the fifth year after cessation of anti-HBV treatment.]
Incidence of sustain HBV viral submission [Срок оценки: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.]
Incidence of sustain biological response [Срок оценки: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.]
Incidence of hepatocellular carcinoma [Срок оценки: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.]
Incidence of Liver failure [Срок оценки: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.]

Критерии участия

Критерии включения

HBsAg positive, HBeAg negative, antibody to HBeAg-positive;
Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year;
Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule;
Patients read, understand the consent form, and signed the study consent.