Predictive Model for Prognosis of Chronic HBV Infection Mothers

• Conditions: Hepatitis B, Chronic
• Interventions: Other: Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level

• Registration Number: NCT04805034
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-18
• Study Start: 2021-04-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1600

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HBeAg positive/HBsAg positive	Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level	-
HBeAg seroconversion /HBsAg loss	Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level	-

Primary Outcome Measures

Name	Time	Method
the rate of HBeAg seroconversion	Postpartum 96weeks
the rate of HBeAg loss	Postpartum 96weeks
the rate of HBsAg loss	Postpartum 96weeks

Secondary Outcome Measures

Name	Time	Method
the rate of undetectable HBV DNA	Postpartum 96weeks
the rate ALT normalization	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

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China