Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients in each group in complete or partial remission
研究概览
简要总结
The purpose of this study is to determine whether Levamisole plus prednisone can further improve the efficacy,extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.
详细描述
The first line treatment in warm antibody autoimmune hemolytic anemia (WAIHA) is the glucocorticoid, but most of the patients, hemolytic events will frequently recurred after end of treatment or during the gradual reduction in dosage of prednisolone. As a result, many patients will finally accepted long-term glucocorticoids or other immunosuppressive drugs. How to reduce the relapse rate of AIHA is still difficult. Levamisole(LMS)is a immunoregulator.Recent studies have shown LMS has been widely used to treat autoimmune diseases ,such as rheumatoid arthritis, systemic lupus erythematosus and idiopathic thrombocytopenic purpura. The purpose of this study is to determine whether LMS combined with prednisolone can further improve the efficacy,extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune hemolytic anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and biochemical signs of hemolytic anaemia
- •Positive Coombs test with anti-IgG or and with anti-CD3d
- •Newly diagnosed Warm Autoimmune Hemolytic Anemia
- •Adequate contraceptive measures for women of childbearing potential
- •informed consent signed
排除标准
- •Active infection which requires antibiotic treatment
- •Pregnant or lactating women
- •Epilepsy and mental illness
- •Kidney and liver function abnormal
研究组 & 干预措施
prednisolone + levamisole
干预措施: levamisole (Drug)
Prednisone
干预措施: Prednisone (Drug)
结局指标
主要结局
Number of patients in each group in complete or partial remission
时间窗: one year
次要结局
- Side effects(1year)
研究者
Yizhou Zheng
Vice director of the therapeutic centre of anemic diseases
Institute of Hematology & Blood Diseases Hospital, China
