A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
ConditionHepatitis B, Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorTongji Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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;
Trial population
the patients with Chronic Hepatitis B
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 2 trial groupsGroup A: Untreated group
Group B: NA treatment group
Trial outcomes
Primary outcomes
1
A preliminary exploration of staging and grading criteria for the state of immune
The clinical characteristics, viral load and immune cells frequency (CD4+ or CD8+ T cells, etc) of CHB in different clinical stages will be studied.
Time frame
week 200Sponsors and contacts
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Source ClinicalTrials.gov