Trials / Unknown
UnknownNCT01579110
Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Anemia
- Anemia, Hemolytic
- Anemia, Hemolytic, Autoimmune
- Hemolysis
- Hematologic Diseases
- Autoimmune Diseases
- Immune System Diseases
- Pathologic Processes
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | Prednisone | Prednisone 1mg/kg for two weeks and then tapered off dosage over two months. |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2015-04-01
- Completion
- 2016-04-01
- First posted
- 2012-04-17
- Last updated
- 2012-04-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01579110. Inclusion in this directory is not an endorsement.