跳至主要内容
临床试验/NCT04805034
NCT04805034Unknown不适用

Predictive Model for Prognosis of E Antigen-positive Mothers With Chronic HBV Infection: A Multicenter Cohort Study

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2021年4月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,600
试验地点
1
主要终点
the rate of HBeAg seroconversion

研究概览

简要总结

Pregnancy is a complex and coordinated physiological process. Pregnancy and the postpartum period are associated with unique changes in the immune system that may impact the natural history of autoimmune diseases and immune-mediated infections. In the postpartum period. ALT flares have been reported in 20%-60% of untreated women and were more likely to occur in hepatitis B e antigen (HBeAg)-positive patients. It has been postulated that postpartum ALT flares may arise to rapid immune restitution against hepatitis B virus (HBV) antigens in the liver, when may be a timing of antiviral treatment. A large number of previous studies have focused on studies on the interruption of mother-to-child transmission in women with chronic hepatitis B(CHB), but studies on the prognosis of mothers undergoing pregnancy and delivery are very limited. What are the factors that affect the clearance of HBeAg or HBsAg? What kind of antiviral treatment protocol should be adopted for mothers with CHB? It is not only a problem that needs to be solved urgently in clinical practice, but also can provide some clues for understanding the occurrence and development of HBV infection in women of childbearing age.

Overall, this study intends to carry out a multi-center two-way cohort study on E antigen-positive CHB women in 9 hospitals in Shaanxi Province. To observe the dynamic changes of virological parameters in these patients, figure out the factors of the serum HBsAg loss and HBeAg seroconversion, and establish relevant predictive models.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 20-45 years old
  • Serum HBsAg positive> 6 months
  • HBeAg positive at delivery
  • Good compliance

排除标准

  • Women who give birth to stillbirth due to various reasons
  • Coinfection with HIV,HCV, syphilis or other sexually transmitted diseases
  • Severe kidney, cardiovascular, lung, nervous system or immune system diseases
  • Who are taking immunotherapy drugs or anti-tumor drugs

结局指标

主要结局

the rate of HBeAg seroconversion

时间窗: Postpartum 96weeks

the rate of HBeAg loss

时间窗: Postpartum 96weeks

the rate of HBsAg loss

时间窗: Postpartum 96weeks

次要结局

  • the rate ALT normalization(Postpartum 96weeks)
  • the rate of undetectable HBV DNA(Postpartum 96weeks)
  • Dynamic changes of serum HBsAg, HBeAg, HBV DNA and HBV RNA titer(at delivery, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks after delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Predictive Model for Prognosis of Chronic HBV... | 临床试验