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

Phase 2

• Conditions: Anemia; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Hemolysis; Hematologic Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes
• Interventions: Drug: levamisole; Drug: Prednisone

• Registration Number: NCT01579110
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

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

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.

Study Timeline

• Status Verified: 2012-04
• Study Start: 2012-04
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-14
• Study First Posted: 2012-04-17
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-19
• Primary Completion: 2015-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prednisolone + levamisole	levamisole	-
Prednisone	Prednisone	-

Primary Outcome Measures

Name	Time	Method
Number of patients in each group in complete or partial remission	one year

Secondary Outcome Measures

Name	Time	Method
Side effects	1year

Trial Locations

Locations (1)

Blood Diseases Hospital Chinese Academy of Medical Sciences; 🇨🇳 TianJin, Tianjin, China