A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Recruiting
Observational Study
Hepatitis B, Chronic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Any
Study type
Observational
Participants needed
250 (estimated)
Sponsor
Tongji Hospital · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 Hepatiti…
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.
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