Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-08 @ 6:00 AM
Study NCT ID:
NCT04805034
Status:
UNKNOWN
Last Update Posted:
2021-08-23
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Model for Prognosis of Chronic HBV Infection Mothers
Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
Predictive Model for Prognosis of E Antigen-positive Mothers With Chronic HBV Infection: A Multicenter Cohort Study
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMFPOEPMWCHI
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: