Predictive Model for Prognosis of Chronic HBV Infection Mothers (PMFPOEPMWCHI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Other: Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level

• Study Type: Observational
• Enrollment (Anticipated): 1600

Contacts and Locations

• Study Contact: Name: Tianyan Chen, phD; Phone Number: 0086-18991232530; Email: chentianyan@126.com
• Study Contact Backup: Name: Naijuan Yao, phD; Phone Number: 0086-13186036653; Email: 897402048@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Tianyan Chen; Phone Number: 0086-18991232530; Email: chentianyan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Mothers with chronic hepatitis B infection

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HBeAg positive/HBsAg positive	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
HBeAg seroconversion /HBsAg loss	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the rate of HBeAg loss	Postpartum 96weeks
the rate of HBeAg seroconversion	Postpartum 96weeks
the rate of HBsAg loss	Postpartum 96weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Shaanxi Provincial People's Hospital; Ankang Central Hospital; Weinan Central Hospital; Yan'an University Affiliated Hospital; Hanzhong Central Hospital; Northwest Women's and Children's Hospital, Xi'an, Shaanxi; the Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine; Baoji Maternal and Child Health Hospital
• Investigators: Study Chair: Tianyan Chen, phD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 16, 2021
• Primary Completion (ANTICIPATED): January 31, 2024
• Study Completion (ANTICIPATED): January 31, 2024

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (ACTUAL): March 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Anti-Infective Agents; Antiviral Agents
• Other Study ID Numbers: XJTU1AF-CRF-2020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No