Prospective RCT Study on the Efficacy and Safety of TAF vs TDF in Early and Middle Pregnancy Antiviral Therapy for Chronic Hepatitis B Pregnant Women
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hepatitis B virus Mother-to-infant blocking rate
研究概览
简要总结
The goal of this clinical trial is to learn the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy antiviral therapy for chronic hepatitis B pregnant women.
The main questions it aims to answer are:
The rate of HBV mother-to-child transmission between the TAF and TDF groups. The incidence of birth defects in newborns between the TAF and TDF groups. What medical problems do participants have when taking drug TAF or TDF? The growth and development indices of newborns between the TAF and TDF groups.
Participants will:
Take drug TAF or TDF every day during the pregnacy. Visit the clinic once every 4 weeks for checkups and tests during the pregnancy and every 12 weeks postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender. Age between 20-40 years old. Positive for HBsAg for ≥6 months. Pregnant at 0-24 weeks meeting the 2022 China Chronic Hepatitis B guidelines for antiviral therapy (including but not elevated transaminases, liver cirrhosis, hepatic fibrosis, or extrahepatic manifestations of hepatitis B).
- •Willingness to take TAF/TDF orally once daily from enrollment until delivery or long-term use.
- •Good medication compliance.
排除标准
- •Co-infection with hepatitis A, C, E viruses, other hepatotropic viruses, or HIV.
- •Liver cirrhosis, liver cancer, or other chronic liver diseases. Significant organ diseases (e.g., heart, lung, or kidney diseases). Autoimmune hepatitis, autoimmune diseases, hypertension, diabetes, or thyroid disorders.
- •History of pregnancy complications. History of fetal/neonatal growth defects in previous pregnancies. Use of nephrotoxic drugs, corticosteroids, NSAIDs, cytotoxic drugs, or immunomodulators prior to enrollment.
- •Abnormal ultrasound findings indicating fetal malformations, placental abnormalities, or threatened miscarriage before treatment initiation.
- •Failure to attend follow-up visits as scheduled.
研究组 & 干预措施
TDF
干预措施: TAF (Drug)
TAF
干预措施: TAF (Drug)
结局指标
主要结局
Hepatitis B virus Mother-to-infant blocking rate
时间窗: participant' infants 7 months old
test HBsAg and HBV-DNA of the infants
次要结局
- Rate of birth defects(When participants gave birth)
- Incidence of complications and adverse drug reactions during pregnancy(From date of randomization until the date of first documented progression, assessed up to 14 months)