Predictive Model for Prognosis of Chronic HBV Infection Mothers

Hepatitis B, Chronic Clinical Trial

— PMFPOEPMWCHI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805034
• Other study ID #: XJTU1AF-CRF-2020-001
• Status: Recruiting
• Start date: April 16, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Tianyan Chen, phD
• Phone: 0086-18991232530
• Email: chentianyan[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic

Intervention

Other:
• Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level
Exposure factors: Age, BMI, Family history, Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (9)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Ankang Central Hospital, Baoji Maternal and Child Health Hospital, Hanzhong Central Hospital, Northwest Women and Children's Hospital, Shaanxi Provincial People's Hospital, the Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine, Weinan Central Hospital, Yan'an University Affiliated Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of HBeAg loss		Postpartum 96weeks
Primary	the rate of HBeAg seroconversion		Postpartum 96weeks
Primary	the rate of HBsAg loss		Postpartum 96weeks
Secondary	the rate of undetectable HBV DNA		Postpartum 96weeks
Secondary	the rate ALT normalization		Postpartum 96weeks
Secondary	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