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

Tongji Hospital

Status: Enrolling

Conditions: Hepatitis B, Chronic

Study type: Observational

Funder types: Other

Identifiers

NCT06525909

OCEAN cure 06 study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

250 participants in 2 patient groups

Untreated group

Description:

The untreated patients who met the staging subgroups of the Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B, 2022 edition or lost HBsAg spontaneously.

NA treatment group

Description:

The patients who achieved HBV DNA suppression by NA.