A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B

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 to establish a staging and grading criteria for the immune exhaustion status of patients with CHB.

Eligibility

Inclusion Criteria:

1. Patients with CHB who were older than 18 years old and younger than 50 years old with HBsAg positivity more than 6 months;
2. 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.
3. Group 2 nucleos(t)ide-treated CHB patients are required to have sustained control of their HBV DNA (\<100 IU/ml).

Exclusion Criteria:

1. Pregnancy status;
2. Has been diagnosed with compensated/lost compensated cirrhosis, hepatocellular carcinoma by imaging or other indicators;
3. Combined HAV, HCV, HEV infection, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, HIV infection;
4. Being on immunosuppressants or immunomodulators or hormonal drugs or biological agents, etc;
5. previous history of oncology, organ transplantation, etc., history of alcoholism (\>30 g/d for men, \>20 g/d for women);
6. Inadequate follow-up time and inadequate clinical/laboratory information;
7. Combined heart, brain, kidney, lung and other organ insufficiency or combined endocrine and haematological system and other major diseases;
8. Comorbid serious psychiatric diseases including severe anxiety or depression;
9. Unwilling to participate in this study.

Conditions2

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