RecruitingNCT06525909
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Sponsor
Tongji Hospital
Enrollment
250 participants
Start Date
Jan 20, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 YearsMax Age: 50 Years
Inclusion Criteria3
- 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 Criteria9
- 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.
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Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06525909
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