跳至主要内容
临床试验/NCT01579110
NCT01579110Unknown2 期

Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.

Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: levamisole (Drug)

Prednisone

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yizhou Zheng

Vice director of the therapeutic centre of anemic diseases

Institute of Hematology & Blood Diseases Hospital, China

研究点 (1)

Loading locations...

相似试验