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Clinical Trials in China / NCT06525909
Recruiting Observational

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

NCT06525909 · tracked via the Priya Life Science China tracker
Sponsor
Tongji Hospital
Phase
Observational
Started
2024-01-20
Last updated
2024-07-29

Condition(s) studied

Hepatitis B, Chronic

Study 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

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Tongji Hospital Wuhan Hubei Recruiting
Beijing YouAn Hospital Beijing China Recruiting
The First Hospital of Jilin University Changchun China Not Yet Recruiting
Southwest Hospital Chongqing China Not Yet Recruiting
Jiangsu Province Hospital Nanjing China Not Yet Recruiting

More Tongji Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06525909 on ClinicalTrials.gov ↗ ← All trials in China