Hemophilia A
Conditions
Keywords
Hemophilia A
Brief summary
The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.
Interventions
DRUGReFacto
DRUGAdvante
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Severe hemophilia A * Previously treated patients with at least 150 exposure days to any Factor VIII product
Exclusion criteria
* Hypersensitivity to any recombinant Factor VIII product * History of or current Factor VIII inhibitor * Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, New Zealand, United Kingdom, United States
Outcome results
None listed