The Incidence of Postpartum Hepatitis in Pregnant Women With High HBVDNA Loads
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- The incidence rate of hepatitis flare after drug withdrawal in maternal postpartum
研究概览
简要总结
The majority of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level. However, there is no withdrawal time recommendations after childbirth at present.Through the study of hepatitis occurrence after delivery and drug withdrawal, the investigators explore the withdrawal time of antiviral treatment during pregnancy.
详细描述
Most of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level, and 11.5% of patients with HBV DNA positive would lead to deterioration of liver function. Meanwhile, the highest peak of ALT level could occur in 2 weeks after delivery, then it would dropped to a low point in 4-5 weeks. However, there is no withdrawal time recommendations after childbirth at present.The aim of our study is to investigate the changes of serological indexes, the changing rule of the liver function, hepatitis status, and its correlation with antiviral therapy in pregnant women with HBV infection after delivery, and then explore the withdrawal time of antiviral treatment during pregnancy.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA > 106 copies/ml
- •healthy Pregnant women with HBsAg(-), HBeAg(-)
排除标准
- •Active consumption of alcohol and/or drugs
- •Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc.
- •History of autoimmune hepatitis
- •Psychiatric disease
- •Evidence of neoplastic diseases of the liver
- •without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.
研究组 & 干预措施
experimental group
pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml start to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation and drug withdrawal after delivery immediately, and drug withdrawal in the 6 weeks after delivery.
干预措施: Tenofovir Disoproxil Fumarate (Drug)
结局指标
主要结局
The incidence rate of hepatitis flare after drug withdrawal in maternal postpartum
时间窗: after delivery 24weeks
ALT \> 3 times the upper limit of normal
次要结局
未报告次要终点
研究者
Yao Xie
Head of liver diseases center
Beijing Ditan Hospital