Back to resultsEfficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
Primary Purpose
Anemia, Anemia, Hemolytic, Anemia, Hemolytic, Autoimmune
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
levamisole
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring autoimmune hemolytic anemia, hemolytic anemia, Levamisole, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia
Eligibility 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
Sites / Locations
- Blood Diseases Hospital Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
prednisolone + levamisole
Prednisone
Arm Description
Outcomes
Primary Outcome Measures
Number of patients in each group in complete or partial remission
Secondary Outcome Measures
Side effects
Full Information
NCT ID
NCT01579110
First Posted
April 13, 2012
Last Updated
April 18, 2012
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT01579110
Brief Title
Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
Official Title
Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Anemia, Hemolytic, Anemia, Hemolytic, Autoimmune, Hemolysis, Hematologic Diseases, Autoimmune Diseases, Immune System Diseases, Pathologic Processes
Keywords
autoimmune hemolytic anemia, hemolytic anemia, Levamisole, Treatment of autoimmune hemolytic anemia, warm antibody dependant autoimmune hemolytic anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prednisolone + levamisole
Arm Type
Experimental
Arm Title
Prednisone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
levamisole
Intervention Description
Levamisole 2.5mg/kg(every other day) over six months.
Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.
Primary Outcome Measure Information:
Title
Number of patients in each group in complete or partial remission
Time Frame
one year
Secondary Outcome Measure Information:
Title
Side effects
Time Frame
1year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhou Zheng, doctor
Organizational Affiliation
Blood Diseases Hospital Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blood Diseases Hospital Chinese Academy of Medical Sciences
City
TianJin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
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