A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Recruiting · NCT06525909 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tongji Hospital
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
Age range
18 Years to 50 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patients with CHB who were older than 18 years old and younger than 50 years old with HBsAg positivity more than 6 months;
- 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.
- Group 2 nucleos(t)ide-treated CHB patients are required to have sustained control of their HBV DNA (\<100 IU/ml).
Exclusion criteria
- Pregnancy status;
- Has been diagnosed with compensated/lost compensated cirrhosis, hepatocellular carcinoma by imaging or other indicators;
- Combined HAV, HCV, HEV infection, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, HIV infection;
- Being on immunosuppressants or immunomodulators or hormonal drugs or biological agents, etc;
- previous history of oncology, organ transplantation, etc., history of alcoholism (\>30 g/d for men, \>20 g/d for women);
- Inadequate follow-up time and inadequate clinical/laboratory information;
- Combined heart, brain, kidney, lung and other organ insufficiency or combined endocrine and haematological system and other major diseases;
- Comorbid serious psychiatric diseases including severe anxiety or depression;
- Unwilling to participate in this study.
Where it is running
5 locations listed.
- Beijing YouAn Hospital - Beijing, China
- The First Hospital of Jilin University - Changchun, China
- Southwest Hospital - Chongqing, China
- Jiangsu Province Hospital - Nanjing, China
- Tongji Hospital - Wuhan, Hubei, China