drugset / Trial / NCT00916032
Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ADVATE | Protein / enzyme biologic | 3000 iu | — |