Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
This trial is active, not recruiting.
|Conditions||anemia, anemia, hemolytic, anemia, hemolytic, autoimmune, hemolysis, hematologic diseases, autoimmune diseases, immune system diseases, pathologic processes|
|Sponsor||Institute of Hematology & Blood Diseases Hospital|
|Start date||April 2012|
|End date||April 2015|
|Trial size||100 participants|
|Trial identifier||NCT01579110, ZXMZ2012|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Number of patients in each group in complete or partial remission
time frame: one year
time frame: 1year
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - Active infection which requires antibiotic treatment - Pregnant or lactating women - Epilepsy and mental illness - Kidney and liver function abnormal
|Official title||Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.|
|Principal investigator||Yizhou Zheng, doctor|
|Description||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.|
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