Status:
RECRUITING
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Lead Sponsor:
Tongji Hospital
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-50 years
Brief Summary
This is a prospective, multicentre observational study of Chronic Hepatitis B （CHB）in different clinical stages. We intend to compare the immune status of various types of CHB patients, and we propose...
Detailed Description
Two groups were included in this study: untreated patients who met the staging subgroups according to Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022 edition or HBsAg ne...
Eligibility Criteria
Inclusion
- Patients with CHB who were older than 18 years old and younger than 50 years old with HBsAg positivity more than 6 months;
- Group 1 untreated group fulfils any one of the four natural history types of the Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022.
- Group 2 nucleos(t)ide-treated CHB patients are required to have sustained control of their HBV DNA (\<100 IU/ml).
Exclusion
- Pregnancy status;
- Has been diagnosed with compensated/lost compensated cirrhosis, hepatocellular carcinoma by imaging or other indicators;
- Combined HAV, HCV, HEV infection, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, HIV infection;
- Being on immunosuppressants or immunomodulators or hormonal drugs or biological agents, etc;
- previous history of oncology, organ transplantation, etc., history of alcoholism (\>30 g/d for men, \>20 g/d for women);
- Inadequate follow-up time and inadequate clinical/laboratory information;
- Combined heart, brain, kidney, lung and other organ insufficiency or combined endocrine and haematological system and other major diseases;
- Comorbid serious psychiatric diseases including severe anxiety or depression;
- Unwilling to participate in this study.
Key Trial Info
Start Date :
January 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 10 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06525909
Start Date
January 20 2024
End Date
December 10 2028
Last Update
July 29 2024
Active Locations (5)
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1
Tongji Hospital
Wuhan, Hubei, China
2
Beijing YouAn Hospital
Beijing, China
3
The First Hospital of Jilin University
Changchun, China
4
Southwest Hospital
Chongqing, China