临床试验/NCT01341808

NCT01341808已完成4 期

Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease

Asan Medical Center2 个研究点分布在 1 个国家目标入组 493 人开始时间: 2011年4月最近更新: 2013年3月19日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Asan Medical Center
入组人数: 493
试验地点: 2
主要终点: antibody titer to hepatitis A vaccine

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to measure the immune response in 18-40 year old IBD patients after receiving the hepatitis A vaccine.

详细描述

The spread of hepatitis A has prompted the need for vaccination against this virus. It is uncertain that IBD patients can achieve a truly protective response after vaccination. The efficacy and safety of hepatitis A vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against hepatitis A in patients with IBD.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients suffering from inflammatory bowel disease: Crohn's disease/Ulcerative colitis
•Willing to provide informed consent

排除标准

•Have history of vaccination to hepatitis A
•Have other autoimmune disease
•Have any malignancy
•Have acute infectious disease
•Unwilling to provide consent

结局指标

主要结局

antibody titer to hepatitis A vaccine

时间窗: Month 7

次要结局

vaccine-associated adverse events and side effects(within the first 30 days after second vaccination)

研究者

发起方

Asan Medical Center

申办方类型

Other

责任方

Principal Investigator

主要研究者

Suk-Kyun Yang

Professor

Asan Medical Center

研究点 (2)

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