NCT00168051WithdrawnPhase 4
A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)
Wyeth is now a wholly owned subsidiary of Pfizer13 sites in 8 countriesStarted: April 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Locations
- 13
- Primary Endpoint
- Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Male
- Accepts 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
Outcomes
Primary Outcomes
Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
Secondary Outcomes
- 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.
Investigators
Study Sites (13)
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