JPRN-jRCTs061180029已完成1 期
Evaluation of safety and protective efficacy of fulminant hepatitis to abatacept treatment of patients with HBV-related severe hepatitis.-Pilot Study
Imamura Michio0 个研究点目标入组 6 人开始时间: 2019年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
We conducted a pilot study for evaluating the efficacy and safety of abatacept, a cytotoxic T lymphocyte antigen-4 immunoglobulin (CTLA4), for acute hepatitis B. Five patients with severe acute hepatitis B (prothrombin activity < 60%) were treated for immunosuppression by abatacept. Five patients received abatacept concurrently with methylprednisolone, and another patient was treated with abatacept alone. Rapid decrease in serum alanine aminotransferase levels, increase in prothrombin activity and improveme
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •Hospitalized patients who satisfied all of the following selection criteria for patients with hepatitis B (acute infection, acute exacerbation, reactivation), understand the purpose of this study, and consent by written document.
- •1) HBs antigen positive
- •2) ALT 100 IU / ml or more
- •3) Male and female with ages 18 to 85 at the time of acquiring consent
排除标准
- •1) PT less than 10%
- •2) PT 61% or more, and either AST or ALT is on a downward trend
- •3) Hepatic encephalopathy 2 degrees or more (Table 2. Classification of coma of hepatic encephalopathy)
- •4) Patients with autoimmune hepatitis
- •5) Patients with a history of hypersensitivity to Orencia
- •6) Patients with severe infection
- •7) In addition, patients judged unsuitable for participation in this study by research doctor.
研究者
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