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

NCT ID: NCT01579110

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prednisolone + levamisole

Group Type: EXPERIMENTAL

levamisole

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Prednisone

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Prednisone

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Yizhou Zheng

Vice director of the therapeutic centre of anemic diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yizhou Zheng, doctor

Role: PRINCIPAL_INVESTIGATOR

Blood Diseases Hospital Chinese Academy of Medical Sciences

Locations

Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

ZXMZ2012

Identifier Type: -

Identifier Source: org_study_id