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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier:
NCT01579110
First received: April 13, 2012
Last updated: April 18, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Institute of Hematology & Blood Diseases Hospital:

Primary Outcome Measures:
  • Number of patients in each group in complete or partial remission [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 1year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 13, 2012
Last Updated: April 18, 2012
Health Authority: China: Ethics Committee

Keywords provided by 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, Hemolytic, Autoimmune
Autoimmune Diseases
Anemia
Anemia, Hemolytic
Hematologic Diseases
Hemolysis
Immune System Diseases
Pathologic Processes
Antibodies
Autoantibodies
Levamisole
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Adjuvants, Immunologic
Anthelmintics
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antinematodal Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiparasitic Agents
Antirheumatic Agents
Autonomic Agents

ClinicalTrials.gov processed this record on November 25, 2014