Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
Public ClinicalTrials.gov record NCT00141843. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00141843
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- ReFacto AF Genetic
- B-Domain deleted Recombinant Factor VIII Genetic
- BDDrFVIII Genetic
Genetic
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2005 (Type not available)
- Primary completion
- Nov 2006 (Actual)
- Completion
- Nov 2006 (Actual)
- Last update posted
- Apr 22, 2008
2005 – 2006
United States locations
- U.S. sites
- 21
- U.S. states
- 18
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | 85016 | — |
| Not listed | Sacramento | California | 95817 | — |
| Not listed | San Diego | California | 92123 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Iowa City | Iowa | 52242 | — |
| Not listed | New Orleans | Louisiana | 70112 | — |
| Not listed | Worcester | Massachusetts | 01605 | — |
| Not listed | East Lansing | Michigan | 48823 | — |
| Not listed | St Louis | Missouri | 63014 | — |
| Not listed | New Brunswick | New Jersey | 08903-0019 | — |
| Not listed | Buffalo | New York | 14215 | — |
| Not listed | New Hyde Park | New York | 11040 | — |
| Not listed | Chapel Hill | North Carolina | 27599 | — |
| Not listed | Dayton | Ohio | 45404 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | Salt Lake City | Utah | 84113 | — |
| Not listed | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00141843, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2008 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00141843 live on ClinicalTrials.gov.