A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
NCT ID: NCT06525909
Last Updated: 2024-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2024-01-20
2028-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
NA treatment group
The patients who achieved HBV DNA suppression by NA.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Group 2 nucleos(t)ide-treated CHB patients are required to have sustained control of their HBV DNA (\<100 IU/ml).
Exclusion Criteria
2. Has been diagnosed with compensated/lost compensated cirrhosis, hepatocellular carcinoma by imaging or other indicators;
3. Combined HAV, HCV, HEV infection, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, HIV infection;
4. Being on immunosuppressants or immunomodulators or hormonal drugs or biological agents, etc;
5. previous history of oncology, organ transplantation, etc., history of alcoholism (\>30 g/d for men, \>20 g/d for women);
6. Inadequate follow-up time and inadequate clinical/laboratory information;
7. Combined heart, brain, kidney, lung and other organ insufficiency or combined endocrine and haematological system and other major diseases;
8. Comorbid serious psychiatric diseases including severe anxiety or depression;
9. Unwilling to participate in this study.
18 Years
50 Years
ALL
Yes
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Qin Ning
Director and Chair of Department of Infectious Diseases
Principal Investigators
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Qin Ning, Doctor
Role: PRINCIPAL_INVESTIGATOR
Department of infectious Diseases, Tongji Hospital
Locations
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Tongji Hospital
Wuhan, Hubei, China
Beijing YouAn Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Southwest Hospital
Chongqing, , China
Jiangsu Province Hospital
Nanjing, , China
Countries
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Central Contacts
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Facility Contacts
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Wei Hou
Role: primary
Junqi Niu
Role: primary
Qing Mao
Role: primary
Chuanlong Zhu
Role: primary
Other Identifiers
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OCEAN cure 06 study
Identifier Type: -
Identifier Source: org_study_id
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