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临床试验/JPRN-UMIN000002568
JPRN-UMIN000002568已完成2 期

The vaccine therapy for chronic hepatitis B - The vaccine therapy for chronic hepatitis B

Department of Gastroenterology and Metabolism, Hiroshima university0 个研究点目标入组 10 人开始时间: 2009年9月30日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
10

研究概览

简要总结

Eight chronic hepatitis B patients, who had received long-term nucleotide analogue treatment, were treated with monthly HBIG injections as an additional treatment. After 1 year of treatment, an HBsAg level reduction of more than 1 log IU/mL was observed in four patients, and three patients became anti-HBs positive. No adverse events occurred during HBIG therapy.

研究设计

研究类型
Interventional

入排标准

年龄范围
ot applicable 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1. Hypersensitivity to nucleotide analogues, HBIG, HB vaccine or any other vaccines 2. Pregnant or nursing 3. Heart disease with uncontrolled status 4. Severe acute disease 5. Fever more than 37.5C 6. Renal dysfunction 7. IgA deficiency 8. Anemia caused by hemolysis or the loss of blood 9. Immunocompromised of immunosuppressive status 10. Chronic liver dysfunction except for HBV infection 11. The others who were disqualified to entry this trial by attending physicians

研究者

发起方
Department of Gastroenterology and Metabolism, Hiroshima university

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