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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Unknown; Phase 2

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

Treatments: Drug: levamisole; Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01579110

ZXMZ2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

prednisolone + levamisole

Experimental group

Treatment:

Drug: levamisole

Prednisone

Active Comparator group

Treatment:

Drug: Prednisone