Actively Recruiting
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Led by Tongji Hospital · Updated on 2024-07-29
250
Participants Needed
5
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to younger than 50 years with Chronic Hepatitis B and HBsAg positivity for more than 6 months
- Untreated patients meeting one of the four natural history types per Chinese Guidelines for Chronic Hepatitis B, 2022 (Group 1)
- Nucleos(t)ide-treated patients with sustained HBV DNA control below 100 IU/ml (Group 2)
You will not qualify if you...
- Pregnancy
- Diagnosed compensated or decompensated cirrhosis, hepatocellular carcinoma
- Co-infection with HAV, HCV, HEV, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, or HIV infection
- Use of immunosuppressants, immunomodulators, hormonal drugs, or biological agents
- History of cancer, organ transplantation, or alcoholism (over 30 g/day for men, over 20 g/day for women)
- Insufficient follow-up time or clinical/laboratory information
- Serious organ insufficiency or major endocrine or blood system diseases
- Serious psychiatric disorders including severe anxiety or depression
- Unwillingness to participate in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
2
Beijing YouAn Hospital
Beijing, China
Actively Recruiting
3
The First Hospital of Jilin University
Changchun, China
Not Yet Recruiting
4
Southwest Hospital
Chongqing, China
Not Yet Recruiting
5
Jiangsu Province Hospital
Nanjing, China
Not Yet Recruiting
Research Team
Q
Qin Ning, Doctor
CONTACT
M
Meifang Han, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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