Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04030039
Status:
UNKNOWN
Last Update Posted:
2019-07-23
First Post:
2019-06-22
Brief Title:
Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention
Sponsor:
Beijing Ditan Hospital
Organization:
Beijing Ditan Hospital
Study Overview
Official Title:
Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention
Status:
UNKNOWN
Status Verified Date:
2019-07
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:
None
Brief Summary:
All chronic hepatitis B CHB patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy interferon and nucleoside analogues reached HBsAg100 IUml The enrolled subjects were divided into the following six observation cohorts 1 CHB patients in the immunological control period without any clinical treatment intervention 2 After interferon therapy HBsAg100 IUml continued interferon therapy 3 After interferon therapy HBsAg100 IUml stopped interferon treatment 4 After interferon therapy HBsAg100 IUml sequential nucleoside analog treatment 5 After nucleoside analogue treatment HBsAg100 IUml sequential interferon treatment 6 After treated with nucleoside analogues HBsAg100 IUml continuing the nucleoside analog treatment The follow-up observation period was 96 weeks under non-planned intervention During the observation period HBV indicators and biochemical indicators serum AFP and liver imaging liver ultrasound were examined regularly The main evaluation index was the incidence of HBsAg disappearance during the observation period Secondary evaluation indicators the rate of HBV DNA turning positive the rate of HBeAg turning positive and hepatitis incidence To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance clinical outcomes and influencing factors in patients with CHB under different antiviral interventions
Detailed Description:
This study is a clinical observational cohort study All chronic hepatitis B patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy interferon and nucleoside analogues reached HBsAg100 IUml The enrolled subjects were divided into the following six observation cohorts 1 chronic Hepatitis B patients in the immunological control period without any clinical treatment intervention in this cohort 2 After interferon therapy HBsAg100 IUml continued interferon therapy in this cohort 3 After interferon therapy HBsAg100 IUml stopped interferon treatment in this cohort 4 After interferon therapy HBsAg100 IUml sequential nucleoside analog treatment in this cohort 5 After nucleoside analogue treatment HBsAg100 IUml sequential interferon treatment in this cohort 6 After treated with nucleoside analogues HBsAg100 IUml continuing the nucleoside analog treatment in this cohort The follow-up observation period was 96 weeks under non-planned intervention During the observation period HBV DNA loads HBsAganti-HBs HBeAganti-HBe and biochemical indicators serum AFP and liver imaging liver ultrasound were examined regularly The main evaluation index was the incidence of HBsAg disappearance during the observation period Secondary evaluation indicators the rate of HBV DNA turning positive the rate of HBeAg turning positive and hepatitis incidence To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance clinical outcomes and influencing factors in patients with CHB under different antiviral interventions
Study Oversight
Has Oversight DMC:
None
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?:
None