Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic Anemia
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|ClinicalTrials.gov Identifier: NCT01997372|
Recruitment Status : Unknown
Verified December 2013 by Xiaofan Zhu, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : November 28, 2013
Last Update Posted : December 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Severe Aplastic Anemia||Drug: ATG||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Different Doses of Anti-thymocyte Globin With 2.5 or 3.75mg/kg to Treat Child Severe Aplastic Anemia|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||November 2015|
|Experimental: high dose ATG,low dose ATG||
Drug ATG:2.5mg/kg/d or 3.75mg/kg/d for 5 days; Drug Cyclosporine A (CSA):3-10mg/kg/d ,Adjust the dose to maintain drug levels between 150 and 300ng/ml; Drug prednisone:1mg/kg/d,d1-21 from the first dosage of ATG; Drug Granulocyte Colony-Stimulating Factor(G-CSF):5ug/kg/d until absolute neutrophil count (ANC) ＞1×109/L.
- the response and complete remission rate with different doses of ATG to treat child severe aplastic anemia [ Time Frame: 1 years ]Complete response (CR) was defined as achieving normal levels of hemoglobin adjusted for age, platelet count >100×109/L, and ANC>1.5×109/L. Partial response (PR) was defined as transfusion independence, reticulocyte count >30×109/L, platelet count >20×109/L, and ANC >0.5×109/L above the baseline. Persistence of transfusion requirement or death was evidence of no response (NR).
- the relapse rate with different doses of ATG to treat child severe aplastic anemia [ Time Frame: 4-10 years ]relapse was defined as transfusion dependence again; or progressed to paroxysmal nocturnal hemoglobinuria (PNH) /acute myeloid leukemia/myelodysplasia syndrome (MDS); or CSA dependence
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997372
|Contact: Xiaofan Zhu, MD||+86 22 email@example.com|
|Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences||Recruiting|
|Tianjin, Tianjin, China, 300020|
|Contact: Xiaofan Zhu, MD +86 22 23909001 firstname.lastname@example.org|