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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01579110

Enrollment

100

Registered

2012-04-17

Start date

2012-04-30

Completion date

2016-04-30

Last updated

2012-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

autoimmune hemolytic anemia, hemolytic anemia, Levamisole, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia

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.

Interventions

DRUGlevamisole

Levamisole 2.5mg/kg(every other day) over six months. Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.

DRUGPrednisone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Side effects	1year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026