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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01579110
• Other study ID #: ZXMZ2012
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 13, 2012
• Last updated: April 18, 2012
• Start date: April 2012
• Est. completion date: April 2016

Study information

• Verified date: April 2012
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.
• Prednisone
Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.

Locations

Country	Name	City	State
China	Blood Diseases Hospital Chinese Academy of Medical Sciences	TianJin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients in each group in complete or partial remission		one year	No
Secondary	Side effects		1year	Yes