drugset / Trial / NCT01445197

Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development

NCT01445197 ↗

Phase 3 Terminated 1 enrolled CSL Behring
NaSingle-groupOpen-labelTreatment

Summary

This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. The antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. The treatment used in this study is called immune tolerance therapy.

Timeline

Start
2012-12
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Biostate Protein / enzyme biologic 200 iu/kg —

Indications