Observational study of immune status in chronic hepatitis B patients

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

This study looks at the immune health of people with chronic hepatitis B to see how it varies in those who are untreated and those who have successfully lowered the virus with medication.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 5 sites (Wuhan, Hubei and 4 other locations)
• Trial ID: NCT06525909 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 50 with chronic hepatitis B who meet specific clinical criteria.

Not a fit: Patients with advanced liver disease, other viral infections, or those on immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved staging and grading criteria for immune status in chronic hepatitis B, enhancing patient management.

How similar studies have performed: While similar studies have explored immune status in hepatitis B, this specific approach to staging and grading immune exhaustion is relatively novel.

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 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 this trial is running

Wuhan, Hubei and 4 other locations

• 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

Conditions Hepatitis B, Chronic