Immune Dynamics in the Natural History of Chronic HBV Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Research Objectives This study aims to investigate the mechanisms underlying the changes and potential deficiencies in humoral and cellular immunity caused by chronic HBV infection through the analysis of clinical samples from patients with hepatitis B. Clinical Investigator will compare the differences in the generation, proliferation, and survival of immune cells among patients with chronic hepatitis B at different immune status stages and explore the role and mechanisms of these differences in anti-HBV immunity. Additionally, clinical Investigator will evaluate their potential impact on the functional cure of hepatitis B.
Study Design As this is an observational study, patients will not be required to undergo additional visits or laboratory tests beyond routine clinical practice. The treatment plan will be determined by the physician according to the instructions and local guidelines. Researchers will review the patient's medical history and laboratory reports to determine eligibility based on inclusion and exclusion criteria. Patients must sign the latest informed consent form approved by the ethics committee before data collection. The frequency and timing of visits will be decided by the physician according to local routine practices. In line with routine clinical practice, follow-ups will be conducted every six months. In this study, laboratory and clinical assessment data will be collected at baseline and every six months. Each participant will be assigned a unique identification number (e.g., HBV1, HBV2), which will be used for all study documents (such as case report forms and clinical records). Participants who meet all inclusion and exclusion criteria and sign the informed consent form will be enrolled in the study. In accordance with data privacy regulations, the use of unique identification numbers is permitted as long as they do not contain combinations of information that can identify participants (for example, the use of participants' initials and date of birth together is not allowed). Participants who withdraw from the study midway will be considered dropouts. When a participant drops out, researchers should try to contact the participant to complete the relevant assessments and fill out the study summary page. Data for this study will be obtained by extracting the participants' routine clinical medical records. Researchers are required to fill out the electronic case report form (eCRF) based on the information in the patient's medical records.
Data Collection Procedures
Baseline Period :
Demographic Data: Record date of birth, gender, and initials. Medical History: Record etiology, current illness history, past medical history, and medication history.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: over a follow-up period of 5 years
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.
次要结局
- The HBV-specific immune response levels will be measured using the immune cells of the enrolled patients(over a follow-up period of five years)