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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

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

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

Arms, Groups and Cohorts

  • Experimental: prednisolone + levamisole
  • Active Comparator: Prednisone

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients in each group in complete or partial remission
    • Time Frame: one year

Secondary Measures

  • Side effects
    • Time Frame: 1year

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Institute of Hematology & Blood Diseases Hospital
    • Provider of Information About this Clinical Study
      • Principal Investigator: Yizhou Zheng, Vice director of the therapeutic centre of anemic diseases – Institute of Hematology & Blood Diseases Hospital
    • Overall Official(s)
      • Yizhou Zheng, doctor, Principal Investigator, Blood Diseases Hospital Chinese Academy of Medical Sciences

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