Trials / Completed
CompletedNCT00141843
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (planned)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | ReFacto AF | |
| GENETIC | B-Domain deleted Recombinant Factor VIII | |
| GENETIC | BDDrFVIII |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2006-11-01
- Completion
- 2006-11-01
- First posted
- 2005-09-01
- Last updated
- 2008-04-22
Locations
41 sites across 13 countries: United States, Australia, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Spain, Sweden
Source: ClinicalTrials.gov record NCT00141843. Inclusion in this directory is not an endorsement.