Predictive Model for Prognosis of Chronic HBV Infection Mothers

NCT04805034 | Unknown

• 1 other identifier: XJTU1AF-CRF-2020-001
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (3)

• the rate of HBeAg loss

  Postpartum 96weeks

• the rate of HBeAg seroconversion

  Postpartum 96weeks

• the rate of HBsAg loss

  Postpartum 96weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

HBeAg positive/HBsAg positive

Other: Age, BMI,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

Interventions

Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level OTHER

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

HBeAg positive/HBsAg positive; HBeAg seroconversion /HBsAg loss

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Mothers with chronic hepatitis B infection

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Aging

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Tianyan Chen, phD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Tianyan Chen, phD

CONTACT

0086-18991232530; chentianyan@126.com

Naijuan Yao, phD

CONTACT

0086-13186036653; 897402048@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 18, 2021
• Study Start: April 16, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

CN (1)