Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic Anemia
1 other identifier
interventional
100
1 country
1
Brief Summary
Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or more and excellent overall survival. However ,there are no clinical trials to illustrate the response and complete remission rate with different doses of ATG.And there are no data reported on children with SAA so far.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2010
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 3, 2013
December 1, 2013
3 years
March 1, 2012
December 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the response and complete remission rate with different doses of ATG to treat child severe aplastic anemia
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).
1 years
Secondary Outcomes (1)
the relapse rate with different doses of ATG to treat child severe aplastic anemia
4-10 years
Study Arms (1)
high dose ATG,low dose ATG
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- clinical diagnosis of childhood acquired severe aplastic anemia(SAA)
You may not qualify if:
- clinical diagnosis of no childhood acquired severe aplastic anemia(SAA)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
Related Publications (1)
Camitta BM, Rappeport JM, Parkman R, Nathan DG. Selection of patients for bone marrow transplantation in severe aplastic anemia. Blood. 1975 Mar;45(3):355-63.
PMID: 1090310RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital
Study Record Dates
First Submitted
March 1, 2012
First Posted
November 28, 2013
Study Start
December 1, 2010
Primary Completion
December 1, 2013
Study Completion
November 1, 2015
Last Updated
December 3, 2013
Record last verified: 2013-12