NCT06525909 A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
| NCT ID | NCT06525909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Hepatitis B, Chronic |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-01-20 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2024-01-20 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patients with CHB who were older than 18 years old and younger than 50 years old with HBsAg positivity more than 6 months; 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: 1. Pregnancy status; 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.
Contact & Investigator
Qin Ning, Doctor
PRINCIPAL INVESTIGATOR
Department of infectious Diseases, Tongji Hospital
Frequently Asked Questions
Who can join the NCT06525909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Hepatitis B, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06525909 currently recruiting?
Yes, NCT06525909 is actively recruiting participants. Contact the research team at qning@vip.sina.com for enrollment information.
Where is the NCT06525909 trial being conducted?
This trial is being conducted at Wuhan, China, Beijing, China, Changchun, China, Chongqing, China and 1 additional location.
Who is sponsoring the NCT06525909 clinical trial?
NCT06525909 is sponsored by Tongji Hospital. The principal investigator is Qin Ning, Doctor at Department of infectious Diseases, Tongji Hospital. The trial plans to enroll 250 participants.