Trials / Completed
CompletedNCT00038935
Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ReFacto AF |
Timeline
- Primary completion
- 2003-02-01
- Completion
- 2003-02-01
- First posted
- 2002-06-07
- Last updated
- 2008-04-22
Source: ClinicalTrials.gov record NCT00038935. Inclusion in this directory is not an endorsement.