NCT06525909

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Two groups were included in this study: untreated patients who met the staging subgroups according to Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022 edition or HBsAg negativity（Group 1). The another is those who achieved HBV DNA suppression by NA（Group 2）. Patients in Group 1 will be followed up once every six months, and in group 2 will be followed up once every three months. And patients treated or not treated will be followed up in the study. The treatment with NA or combined with interferon will be decided by the consensus of doctors and patients. This study does not intervene the treatment, but will register the clinical indicators. We follow up the patients at each follow-up time point, record the subjects' clinical indicators at each visit and obtained serum and PBMC specimens for further immune study after the consents of the patients.

Conditions

• Hepatitis B, Chronic

Timeline

• Start date: 2024-01-20
• Primary completion: 2026-12-01
• Completion: 2028-12-10
• First posted: 2024-07-29
• Last updated: 2024-07-29

Locations

5 sites across 1 country: China