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
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multicenter observational study to understand the immune status in people with Chronic Hepatitis B (CHB) at different clinical stages. The study aims to compare the immune system status among various types of CHB patients and develop criteria to stage and grade immune exhaustion in these patients. This research follows current guidelines and includes patients with different treatment backgrounds to better characterize immune responses in CHB. The study includes two groups: untreated patients who fall into specific staging categories based on Chinese guidelines or have lost HBsAg spontaneously, and patients who have achieved suppression of HBV DNA through nucleos(t)ide analogues (NA) treatment. Group 1 patients are followed every six months, while Group 2 patients have follow-ups every three months. Treatment decisions, including use of NA or combined interferon, are made by doctors and patients outside of the study, which does not interfere with treatment but collects clinical data and biological samples for immune study. Participants will be monitored regularly with clinical evaluations, and blood samples will be collected to study immune markers. The main outcome is to explore preliminary staging and grading criteria for immune status by week 200 of follow-up. The study collects detailed clinical indicators at each visit to better understand immune exhaustion in CHB. The total participation duration varies depending on individual follow-up schedules.
CONDITIONS
Brief 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 50 years with Chronic Hepatitis B and HBsAg positivity for more than 6 months
- Untreated patients meeting any one of the four natural history types in the Chinese Guidelines for Prevention and Control of Chronic Hepatitis B, 2022
- Patients treated with nucleos(t)ide analogues who have sustained HBV DNA control (<100 IU/ml)
You will not qualify if you...
- Pregnancy
- Diagnosis of compensated or lost compensated cirrhosis, or 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
- Use of immunosuppressants, immunomodulators, hormonal drugs, or biological agents
- History of cancer, organ transplantation, or alcoholism (>30 g/day for men, >20 g/day for women)
- Inadequate follow-up time or incomplete clinical/laboratory data
- Severe heart, brain, kidney, lung, endocrine, hematological, or other major diseases
- Serious psychiatric illnesses including severe anxiety or depression
- Unwillingness to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 4 years
Participants are followed up regularly to record clinical indicators and collect serum and PBMC specimens for immune study. Follow-up frequency depends on group assignment.
Visits every 6 months for untreated group; visits every 3 months for NA treatment group
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
M
Meifang Han, Doctor
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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