Overview

This trial is active, not recruiting.

Conditions anemia, anemia, hemolytic, anemia, hemolytic, autoimmune, hemolysis, hematologic diseases, autoimmune diseases, immune system diseases, pathologic processes
Treatments levamisole, prednisone
Phase phase 2
Sponsor Institute of Hematology & Blood Diseases Hospital
Start date April 2012
End date April 2015
Trial size 100 participants
Trial identifier NCT01579110, ZXMZ2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
levamisole
Levamisole 2.5mg/kg(every other day) over six months. Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.
(Active Comparator)
prednisone
Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.

Primary Outcomes

Measure
Number of patients in each group in complete or partial remission
time frame: one year

Secondary Outcomes

Measure
Side effects
time frame: 1year

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Institute of Hematology & Blood Diseases Hospital.