NCT02874586Unknown不适用
Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis
Xiaoli Fan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent of patients that achieve biochemical remission of AIH
研究概览
简要总结
An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with auto-immune hepatitis based on liver biopsy results, with the indications of immunosuppressive therapy;
- •High levels of total bilirubin (TB) (≥10 X ULN);
- •High levels of immunoglobulin G(IgG) (≥1.5 X ULN);
- •Agreed to participate in the trial, and assigned informed consent;
排除标准
- •The presence of hepatitis A, B, C, D, or E virus infection;
- •Patients with presence of liver cirrhosis or portal hypertension;
- •Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
- •Pregnant and breeding women;
- •Patients with severe anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 2500/mm3), or thrombocytopenia (platelet count < 50,000/mm3);
- •Severe disorders of other vital organs, such as severe heart failure, cancer;
- •Parenteral administration of blood or blood products within 6 months before screening;
- •Recent treatment with drugs having known liver toxicity;
- •Taken part in other clinic trials within 6 months before screening.
结局指标
主要结局
Percent of patients that achieve biochemical remission of AIH
时间窗: Month 6 after the treatment initiated
次要结局
- Alanine transaminase (ALT)(Day 1, and Week 1, 2, 4, 12, 24)
- Globin(GLB)(Day 1, and Week 1, 2, 4, 12, 24)
- Total bilirubin(TB)(Day 1, and Week 1, 2, 4, 12, 24)
- Immunoglobulin G(IgG)(Day 1, and Week 1, 2, 4, 12, 24)
- Direct bilirubin(DB)(Day 1, and Week 1, 2, 4, 12, 24)
- Aspartate transaminase(AST)(Day 1, and Week 1, 2, 4, 12, 24)
研究者
Xiaoli Fan
Principal Investigator
West China Hospital
研究点 (1)
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