NCT07137247 Immune Dynamics in the Natural History of Chronic HBV Infection
| NCT ID | NCT07137247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | HBV (Hepatitis B Virus) |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2040-12-01 |
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 5,000 participants in total. It began in 2024-02-01 with a primary completion date of 2040-12-01.
⚠ 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
The purpose of this observational study is to follow up on chronic HBV-infected patients over a long period of time to understand the changes in the immune status as age increases and the natural history of chronic HBV infection progresses. The main questions it aims to answer are: * Does the natural history of chronic HBV infection progress with changes in HBV-specific immunity? * What is the role of age in the natural history of chronic HBV infection? Patients with chronic HBV infection who are untreated and aged 1-80 years will be followed up every six months. During each follow-up, HBV-related serological and virological indicators will be tested. Peripheral blood samples will also be collected to test HBV-specific immunity and the immune environment.
Eligibility Criteria
Inclusion Criteria: * Aged 1-80 years, either male or female. * Patients diagnosed with chronic hepatitis B virus infection in accordance with the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2019 edition). * No antiviral treatment (including nucleoside analogs and interferons, etc.) within the past six months. Exclusion Criteria: • Concurrent Infections and Liver Diseases: Exclusion of patients with concurrent HCV or HIV infection, alcoholic fatty liver disease, non-alcoholic fatty liver disease, autoimmune liver diseases. • Immune and Coagulation System Disorders: Exclusion of patients with immune system diseases such as hyperthyroidism, coagulation system disorders such as diabetes mellitus or idiopathic thrombocytopenic purpura. * Severe Underlying Diseases. Exclusion of patients with severe underlying diseases that affect the body's immune status. * Other Unsuitable Conditions: Exclusion of patients whom the investigator deems to have other conditions that make them unsuitable for enrollment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07137247 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 80 Years, studying HBV (Hepatitis B Virus). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07137247 currently recruiting?
Yes, NCT07137247 is actively recruiting participants. Contact the research team at yongyinli@foxmail.com for enrollment information.
Where is the NCT07137247 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07137247 clinical trial?
NCT07137247 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 5,000 participants.