HBV Reactivation in Anti CD20 Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- HBV DNA in the blood.
研究概览
简要总结
The goal of this observational study is to test and describe the frequency of hepatitis B virus reactivation in patients who received anti-CD20 drugs for a wide variety of autoimmune and hemato-oncological diseases in order to find out whether a group of patients from a certain field was more sensitive to treatment in this respect than patients from other fields.
详细描述
Hepatitis B virus(HBV) is the most common chronic virus worldwide. it causes an infection of the liver (hepatitis B) and it is transmitted from person to person through contact with virus-contaminated blood, through sexual intercourse, and vertically from mother to fetus.
Anti CD20 drug or Rituximab is an anti-CD20 monoclonal antibody on the surface of B lymphocytes, which induces cell death (apoptosis) and thus causes depletion. The main side effects of rituximab are infectious and hypersensitivity reactions. It can also increase the chance of hepatitis B reactivation to the point of acute hepatitis.
The information for this retrospective study will be collected from clalit health care's databases.
The patients will be sorted according to the indications for which the treatment with anti-CD20 drugs was given in order to see the differences in the response to the drug in different groups of patient
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects (men and women) of age 18 and above, who received anti-CD20 (Rituximab) drugs as a treatment for a variety of diseases .
排除标准
- •healthy subjects.
- •subjects under the age
- •subjects who did not receive anti CD20
结局指标
主要结局
HBV DNA in the blood.
时间窗: about 10 minutes per blood test.
Reactivation of HBV is defined when one of these three conditions exist: 1. when Participant has An increase of more than log1 in the concentration of HBV DNA in the blood. 2. when Participant has A positive HBV DNA result compared to a negative result before starting treatment with Rituximab (anti CD20). 3. when Participant has HDV (hepatitis D virus) DNA result greater than 20000 IU/mL in the absence of a test before starting treatment * The HBV DNA concentration at the beginning of the treatment was defined in the time period between six months before the start of the treatment and 30 days after the start of the treatment.
次要结局
未报告次要终点
研究者
Rawi Hazzan
Head of liver unit
HaEmek Medical Center, Israel