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

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ClinicalTrials.gov Identifier: NCT01579110
Recruitment Status : Unknown
Verified April 2012 by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2012
Last Update Posted : April 19, 2012
Sponsor:
Information provided by (Responsible Party):
Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Hemolysis Hematologic Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Drug: levamisole Drug: Prednisone Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
Study Start Date : April 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Steroids

Arms and Interventions
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Arm Intervention/treatment
Experimental: prednisolone + levamisole 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.
Active Comparator: Prednisone Drug: Prednisone
Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients in each group in complete or partial remission [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: 1year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579110


Locations
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China, Tianjin
Blood Diseases Hospital Chinese Academy of Medical Sciences
TianJin, Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Principal Investigator: Yizhou Zheng, doctor Blood Diseases Hospital Chinese Academy of Medical Sciences
More Information
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Responsible Party: Yizhou Zheng, Vice director of the therapeutic centre of anemic diseases, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT01579110    
Other Study ID Numbers: ZXMZ2012
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012
Keywords provided by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital:
autoimmune hemolytic anemia
hemolytic anemia
Levamisole
Treatment of autoimmune hemolytic anemia
warm antibody dependant autoimmune hemolytic anemia
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Autoimmune Diseases
Immune System Diseases
Hemolysis
Pathologic Processes
Levamisole
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Adjuvants, Immunologic
Immunologic Factors
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents