Clinical trial
Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison…
NCT00357656 · Baxalta now part of Shire, Industry · Completed
Key facts
| NCT number | NCT00357656 |
|---|---|
| Title | Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison of Continuous Infusion Versus Intermittent Bolus Infusion in Hemophilia A Subjects Undergoing Major Orthopedic Surgery |
| Official title | Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF PFM): A Phase 3/4, Prospective, Controlled, Randomized, Multi-Center Study to Compare the Efficacy and Safety of Continuous Infusion (CI) Versus Intermittent Bolus Infusion (BI) in Subjects With Severe or Moderately Severe… |
| Lead sponsor | Baxalta now part of Shire, Industry |
| Collaborators | Baxalta Innovations GmbH, now part of Shire Industry |
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Hemophilia A |
| Intervention type | Drug |
| Interventions | Recombinant Protein-Free Factor VIII (rAHF-PFM) |
| Enrollment | 85 |
| Start date | May 29, 2006 |
| Primary completion | Oct 1, 2015 |
| Completion | Dec 9, 2015 |
| First posted | Jul 27, 2006 |
| Last update posted | May 19, 2021 |
| Countries | Austria, Belgium, France, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Russia, Spain and 2 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: