drugset / Trial / NCT03598725

Low-dose ITI Strategy for Children in Hemophilia A With High-titer Inhibitor and Poor ITI Risk in China

NCT03598725

Phase 4 Unknown 55 enrolled Beijing Children's Hospital
NaSingle-groupOpen-labelTreatment

Summary

The study start on January 18, 2017. The Severe(FⅧ\<1%) and moderate hemophilia A (FⅧ1%~5%)children with high titer inhibitor(historical peak inhibitor titer≥5BU ) combining with poor ITI risk(s) were enrolled. The low-dose ITI was alone or combined with immunosuppression.

Timeline

Start
2016-01-01
Primary completion
2019-12-01
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Coagulation Factor VIII Protein / enzyme biologic 50 iu/kg
Subject Prednisone Other / unclassified 2 mg/kg
Subject Rituximab Monoclonal antibody 375 mg/m2

Indications