EUCTR2010-023947-14-ES进行中（未招募）1 期
Prospective, Randomized and Comparative Study to evaluate the efficacy of two vaccines against Hepatitis B virus in inflammatory bowel disease patients - COMVI-B Proyect
Hospital Universitario La Princesa0 个研究点开始时间: 2011年9月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients diagnosed of IBD with negative HBV serology.
- •2) Men & women commited to abstinence of sexual relations or to use, al least, an effective birth control method (condom, diaphragm, IUD)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 118
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 118
排除标准
- •1- Age below 18 years old.
- •2- Advanced Chronic Disease or any other disease that prevent from attending controls and follow-up.
- •3- Allergy to any of the vaccine components.
- •4- Previous vaccination to the HBV.
- •5- Women willing to get pregnant.
- •6- Pregnancy or breastfeeding.
- •7- alcohol abuse.
- •8- Positive serology to HBV.
- •9- People with immune disorders caused by other causes than treatments administered to control IBD.
- •10- People with chronic antibiotic treatment.
- •11- Lack of consent for participating in the study.
研究者
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