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NCT00243659 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
A Phase 3 study of Hemophilia A, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 17
- Study locations
NCT00243659: Completed Phase 3 study of Hemophilia A, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00243659 is a Phase 3 study of Hemophilia A that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 30 participants, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (67% lower). The trial reports 17 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00243659, a Phase 3 study of Hemophilia A, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 17
- Study locations
Study Summary
This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).
Primary Outcome
Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.
Conditions Studied
Interventions
- BIOLOGICAL ReFacto AF
Study Locations (17)
Other
- - Perth
- - Vienna
- - Budapest
- - Auckland
- - Chirstchurch
- - Warsaw
- - Bucurest
- - Malmo
- - Stockholm
Michigan
- - Detroit
- - Detroit
Pennsylvania
- - Hershey
- - Pittsburgh
California
- - La Jolla
North Carolina
- - Chapel Hill
Texas
- - Houston
Virginia
- - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-04 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
What the finished NCT00243659 record still lists
NCT00243659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which ReFacto AF is the first listed.
NCT00243659 lists 17 locations in 7 states (Other, Michigan, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT00243659 about?
NCT00243659 is a clinical study titled "Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery". This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).
What is the current status of trial NCT00243659?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2006-04. Estimated completion is 2008-06.
What conditions does trial NCT00243659 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT00243659?
The interventions under investigation include: ReFacto AF (BIOLOGICAL).
Who is sponsoring clinical trial NCT00243659?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00243659 being conducted?
This trial has 17 study locations across California, Michigan, North Carolina, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia A
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00243659's enrollment target sits among peer trials
30 25th of 42 higher than 18 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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