Immune Dynamics in the Natural History of Chronic HBV Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-80
SponsorNanfang Hospital, Southern Medical University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Severe Underlying Diseases. Exclusion of patients with severe underlying diseases that affect the body's immune status.
Trial population
The study population consists of chronic hepatitis B patients who have not received antiviral therapy within the past six months.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Venipuncture
Procedure/SurgeryFor adults (including those who are 18 years old): During the routine follow-up visits, an extra 30 milliliters of peripheral blood will be drawn. For minors (under 18 years old): During the routine follow-up visits, an extra 6 milliliters of peripheral blood will be drawn. Follow-ups will be conducted every six months, with a minimum of six visit points.
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Chronic hepatitis B virus (HBV) infection1 intervention
Trial outcomes
Primary outcomes
1
In accordance with the 2018 AASLD Hepatitis B guidelines, the natural history of HBV is staged based on the laboratory test results (HBV serological markers, viral load, and liver function) and imaging findings of the enrolled patients.
Enrolled patients will undergo examinations of HBV serological markers, viral load, liver function, liver ultrasound, and liver fibrosis every six months. Subsequently, based on the 2018 AASLD Hepatitis B guidelines , patients will be staged to observe whether there are changes in the natural history of hepatitis B.
Time frame
over a follow-up period of 5 yearsSecondary outcomes
1
The HBV-specific immune response levels will be measured using the immune cells of the enrolled patients
During the biannual follow-up visits, blood samples from the enrolled patients will be used to detect the levels of HBV-specific immunity and other laboratory indicators after restimulation with HBV peptide pools
Time frame
over a follow-up period of five yearsSponsors and contacts
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Source ClinicalTrials.gov