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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anemia, Anemia, Hemolytic, Anemia, Hemolytic, Autoimmune, Hemolysis, Hematologic Diseases, Autoimmune Diseases, Immune System Diseases, Pathologic Processes

Intervention / Treatment
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* Drug: levamisole
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prednisolone + levamisole<br> | Drug: levamisole<br>* Levamisole 2.5mg/kg(every other day) over six months. Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.<br>|
| Active Comparator: Prednisone<br> | Drug: Prednisone<br>* Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in each group in complete or partial remission |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | 1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autoimmune hemolytic anemia, hemolytic anemia, Levamisole, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia