Anemia, Hemolytic, Aplastic Anemia,, Bone Marrow Failure, Hemoglobinuria, Hemoglobinuria, Paroxysmal, Paroxysmal Nocturnal Hemoglobinuria, Proteinuria, Thrombosis, Urination Disorders
Conditions
Keywords
Paroxysmal Nocturnal Hemoglobinuria, Anemia, Hematologic Diseases, bone marrow failure, Immunologic Factors, Physiological Effects of Drugs, Levamisole, cyclosporine A
Brief summary
Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria.
Detailed description
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, Patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria
Interventions
Levamisole 2.5mg/kg every other day cyclosporin A 1.5-2.5mg/kg every other day Glucocorticoids0.5-1mg/kg every day(prednisone)
cyclosporin A 1.5-2.5mg/kg every day Glucocorticoids0.5-1mg/kg every day(prednisone)
DRUGGlucocorticoids
Glucocorticoids 0.5-1mg/kg every day(prednisone)
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical and biochemical signs of classic Paroxysmal Nocturnal Hemoglobinuria 2. Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data 3. patient should complete levamisole study for at least half a year
Exclusion criteria
1. Active infection which requires antibiotic treatment 2. Pregnant or lactating women 3. Epilepsy and mental illness 4. Kidney and liver function abnormal 5. patient who terminate ealy from levamisole study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients in each group in complete or partial remission | 6 months | she got blood transfusion-independent,the hemoglobin became higher |
Secondary
| Measure | Time frame |
|---|---|
| Side effects | 6 months |
Countries
China
Outcome results
None listed