drugset / Trial / NCT01997372

Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic Anemia

NCT01997372

Phase 4 Unknown 100 enrolled Chinese Academy of Medical Sciences
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-12
Primary completion
2013-12
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 2.5 mg/kg
Subject ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 3.75 mg/kg