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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579110
First Posted: April 17, 2012
Last Update Posted: April 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital
  Purpose
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 Intervention Phase
Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Hemolysis Hematologic Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Drug: levamisole Drug: Prednisone Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital:

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

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

Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
China, Tianjin
Blood Diseases Hospital Chinese Academy of Medical Sciences
TianJin, Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
Principal Investigator: Yizhou Zheng, doctor Blood Diseases Hospital Chinese Academy of Medical Sciences
  More Information

Responsible Party: Yizhou Zheng, Vice director of the therapeutic centre of anemic diseases, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT01579110     History of Changes
Other Study ID Numbers: ZXMZ2012
First Submitted: April 13, 2012
First Posted: April 17, 2012
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:
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Autoimmune Diseases
Hematologic Diseases
Hemolysis
Immune System Diseases
Pathologic Processes
Antibodies
Immunoglobulins
Levamisole
Autoantibodies
Prednisolone acetate
Methylprednisolone acetate
Prednisone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents