Observational study of immune status in chronic hepatitis B patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the immune status of patients with chronic hepatitis B (CHB) across different clinical stages. It includes two groups: untreated patients who meet specific criteria and those who have achieved HBV DNA suppression through nucleos(t)ide therapy. Patients will be followed up at regular intervals, with clinical indicators recorded and biological specimens collected for further immune analysis. The study does not involve any treatment interventions but focuses on understanding the immune exhaustion status in CHB patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China 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

Study contacts

• Principal investigator: Qin Ning, Doctor — Department of infectious Diseases, Tongji Hospital
• Study coordinator: Qin Ning, Doctor
• Email: qning@vip.sina.com
• Phone: 862783662391

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.