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
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Sponsor:
Institute of Hematology & Blood Diseases Hospital
Information provided by (Responsible Party):
Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | April 13, 2012 | |||
First Posted Date ICMJE | April 17, 2012 | |||
Last Update Posted Date | April 19, 2012 | |||
Study Start Date ICMJE | April 2012 | |||
Estimated Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of patients in each group in complete or partial remission [ Time Frame: one year ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Side effects [ Time Frame: 1year ] | |||
Original Secondary Outcome Measures ICMJE |
sustained response, cumulative doses of prednisone and side effects [ Time Frame: 1year ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia. | |||
Official Title ICMJE | Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
100 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | April 2016 | |||
Estimated Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01579110 | |||
Other Study ID Numbers ICMJE | ZXMZ2012 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Institute of Hematology & Blood Diseases Hospital | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Institute of Hematology & Blood Diseases Hospital | |||
Verification Date | April 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |