Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria
This trial is active, not recruiting.
|Conditions||paroxysmal nocturnal hemoglobinuria, hemoglobinuria, hemoglobinuria, paroxysmal, proteinuria, urination disorders, thrombosis, bone marrow failure, aplastic anemia,, anemia, hemolytic|
|Treatments||levamisole+cyclosporin a+glucocorticoids, cyclosporin a+glucocorticoids, glucocorticoids|
|Sponsor||Institute of Hematology & Blood Diseases Hospital|
|Start date||July 2012|
|End date||July 2016|
|Trial size||120 participants|
|Trial identifier||NCT01642979, PNH-2012|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Number of patients in each group in complete or partial remission
time frame: 6 months
time frame: 6 months
Male or female participants at least 18 years old.
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
|Official title||Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria|
|Principal investigator||yizhou zheng, doctor|
|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|
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