A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:
• 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).
Locations
Other Locations
China
Beijing YouAn Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Southwest Hospital
NOT_YET_RECRUITING
Chongqing
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Qin Ning, Doctor
qning@vip.sina.com
862783662391
Backup
Meifang Han, Doctor
mfan@foxmail.com
862783662391
Time Frame
Start Date: 2024-01-20
Estimated Completion Date: 2028-12-10
Participants
Target number of participants: 250
Treatments
Untreated group
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
The patients who achieved HBV DNA suppression by NA.
Related Therapeutic Areas
Sponsors
Leads: Tongji Hospital