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Набор по приглашению NCT07668934

TAF in Early/Middle Pregnancy With CHB

Фаза IV С лечением Hepatitis B Infection Pregnant Women Early Pregnancy

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: TAF, TDF.
Кому может быть актуально
Состояния в реестре: Hepatitis B Infection, Pregnant Women, Early Pregnancy. Базовые параметры: 20 лет — 40 лет · Женщины.
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

Efficacy and Safety of TAF Used in Early and Middle Pregnancy With Chronic Hepatitis B: a Multicenter Prospective Cohort Study

Обзор

The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B.

Подробное описание

The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B. Previous studies have found that TAF has good clinical efficacy in the treatment of antiviral therapy in patients with chronic hepatitis B. In order to evaluate the clinical efficacy of TAF after antiviral therapy in pregnant women with chronic hepatitis B in the first and second trimesters, the clinical efficacy of TAF after antiviral therapy was evaluated by comparing the safety (including changes in maternal ALT, bilirubin, creatinine, blood phosphorus, blood lipids, fetal malformation rate, neonatal birth defects, head circumference, height, weight, intelligence and other indicators) and effectiveness (viral load decrease, serological conversion, mother-to-fetal blockade, etc.) with the TDF group.

Вмешательства

  • Препарат TAF
    Taking TAF from early or middle pregnancy
  • Препарат TDF
    Taking TDF from early or middle pregnancy

Первичные конечные точки

  • To assess the incidence of ALT above normal (>=1 time) of mother [Срок оценки: not more than 48 weeks]
Вторичные конечные точки (12)
  • To assess the level of HBV-DNA of baby [Срок оценки: not more than 7 months]
  • To assess the level of HBV-DNA of mother [Срок оценки: not more than 48 weeks]
  • To assess the results of liver Ultrasound of mother [Срок оценки: not more than 48 weeks]
  • To assess the weight in kilograms of baby [Срок оценки: not more than 7 months]
  • To assess the height in meters of baby [Срок оценки: not more than 7 months]
  • The number of HBsAg positive of baby [Срок оценки: not more than 7 months]
  • The number of HBeAg positive of baby [Срок оценки: not more than 7 months]
  • The number of HBsAg positive of mother [Срок оценки: not more than 48 weeks]
  • The number of HBeAg positive of mother [Срок оценки: not more than 48 weeks]
  • The rate of deformity [Срок оценки: not more than 48 weeks]
  • The rate of Birth defect [Срок оценки: 1 day]
  • The levels of creatinine of mother [Срок оценки: not more than 48 weeks]

Критерии участия

Критерии включения

  • Between the ages of 20 and 40
  • HBsAg positive for >= 6 months
  • 0-24 week of pregnancy
  • Meets the indications for antiviral therapy in the 2022 version of the guidelines for the prevention and treatment of chronic hepatitis B
  • It is planned to use TAF or TDF antiviral therapy until the end of delivery or long-term administration, and follow-up will be carried out in this research institution
  • Signed informed consent for medication

Критерии исключения

  • Previous use of anti-hepatitis B virus drugs (e.g., entecavir, tenofovir, tenofovir alafenol, emintenofovir, adefovir dipoproxil, telbivudine, etc.)
  • Concomitant viral hepatitis A, C, E or other hepatotropic virus infection or AIDS
  • Concomitant cirrhosis, liver cancer or other chronic liver diseases (e.g., alcoholic liver, autoimmune liver disease, G6PD deficiency, etc.)
  • Patients with heart (such as coronary heart disease, myocardial infarction, heart failure, etc.), lung (such as: lung cancer, chronic obstructive pulmonary disease, tuberculosis, etc.), kidney (such as: renal failure, elevated creatinine, nephritis, nephrotic syndrome, etc.) and other important organ diseases
  • Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, etc
  • Patients with previous pregnancy complications (such as: gestational hypertension, gestational diabetes, gestational eclampsia, etc.)
  • Those who have had fetal or neonatal growth and development defects in previous pregnancies
  • Previous or ongoing use of nephrotoxic medications, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators
  • Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, threatened abortion, etc

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Third Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07668934 · [2025]004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗