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

History of Changes

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:

MedlinePlus related topics: Anemia Autoimmune Diseases Blood Disorders Steroids

Drug Information available for: Prednisolone Prednisolone acetate Prednisone Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

U.S. FDA Resources

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

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
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Autoimmune Diseases
Hematologic Diseases
Hemolysis
Immune System Diseases
Pathologic Processes
Antibodies
Autoantibodies
Levamisole
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone

Methylprednisolone Hemisuccinate
Prednisone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Adjuvants, Immunologic
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2013

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