drugset / Trial / NCT00916032

Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A

NCT00916032

Phase 4 Completed 29 enrolled Baxalta now part of Shire
RandomizedCrossoverOpen-labelTreatment

Summary

The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate using two vials of 1500 IU potency dissolved in 5 mL diluent each (administered in 10 mL diluent in total) in previously treated patients with severe hemophilia A (factor VIII level \< 1%).

Timeline

Start
2009-06-29
Primary completion
2010-04-01
Completion
2010-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator ADVATE Protein / enzyme biologic 3000 iu

Indications