A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Recruiting now
Conditions studied: Hepatitis B, Chronic
In brief
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.
Key facts
- Study ID
- NCT06525909
- Run by
- Tongji Hospital
- People needed
- 250
- Starts
- 2024-01-20
- Expected to finish
- 2028-12-10
- Last updated by the study team
- 2024-07-29
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Tongji Hospital — Wuhan, Hubei, China (enrolling)
- Beijing YouAn Hospital — Beijing, China (enrolling)
- The First Hospital of Jilin University — Changchun, China
- Southwest Hospital — Chongqing, China
- Jiangsu Province Hospital — Nanjing, China
Full record on ClinicalTrials.gov
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