Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- protective level of anti HBs antibodies
研究概览
简要总结
The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Male/female ≥ 18 years of age
- •Evidence of IBD as diagnosed by clinical, laboratory imaging and endoscopic criteria.
- •Treated with at least one immunosuppressive medication at the time of study initiation
- •Provided written informed consent.
排除标准
- •Pregnant women
- •Diagnosis of chronic viral hepatitis B
- •Any major acute medical event in the 30 days prior to recruitment that necessitated hospitalization ( acute myocardial infarction, CVA, pulmonary emboli, sepsis, major trauma)
- •Any other chronic inflammatory condition not related to IBD ( connective tissue disease, Chronic liver disease, COPD, poorly controlled diabetes mellitus)
- •Active hematologic or oncologic diseases
结局指标
主要结局
protective level of anti HBs antibodies
时间窗: 1 month after the last does of vaccine
Antibody titer \>10 IU/ml 30 days following last vaccine dose will be considered protective. In the work done by Altunoz et al., titer rate below 10 IU was observed in 40% of the patients, while 40% of the patients achieved a rate of above 100 IU. Therefore, we can estimate that the geometric mean of distribution is approx. 50 IU. A sample size of 37 patients in each group achieves a power of 80% to detect a ratio above 1.37 between the two vaccinated groups.
次要结局
未报告次要终点
研究者
Ohad Etzion
Senior physician, Department of Gastroenterology and Liver Disease
Soroka University Medical Center