Clinical trial NCT06525909: A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Official title: A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B, Chronic
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients with Chronic Hepatitis B

Brief 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.

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.

Primary outcomes:
measure: A preliminary exploration of staging and grading criteria for the state of immune
timeFrame: week 200
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Beijing
country: China
facility: Beijing YouAn Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Chongqing
country: China
facility: Southwest Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
Study officials:
affiliation: Department of infectious Diseases, Tongji Hospital
name: Qin Ning, Doctor
role: PRINCIPAL_INVESTIGATOR
References: