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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
NCT00357656 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to compare the hemostatic efficacy and safety of continuous infusion versus intermittent bolus infusion in the peri- and post-operative setting, employing rAHF-PFM, a recombinant antihemophilic factor manufactured without added human or animal proteins, in previously treated patients with severe or moderately severe hemophilia A (baseline factor VIII level \<= 2% of normal) who are undergoing unilateral major orthopedic surgery that requires drain placement. The total study period per subject (from consent to study completion) will vary from approximately 9 to 26 weeks and will involve clinical and laboratory assessments.
Conditions Studied
Interventions
- DRUG Recombinant Protein-Free Factor VIII (rAHF-PFM)
Study Locations (20)
Other
- University Hospital for Internal Medicine I (Hematology/Hemostaseology) — Vienna
- Cliniques Universitaires St. Luc, Haematology Department — Brussels
- University Hospital Gasthuisberg — Leuven
- Hôpital Edouard Herriot — Lyon
- State Health Centre, National Hemophilia Centre — Budapest
- University of Debrecen, 2nd Dept of Internal Medicine — Debrecen
- PTE ÁOK I. Internal Medical Clinic, Dept of Hematology — Pécs
- Centro Emofilia e Trombosi "Angelo Bianchi Bonomi" — Milan
- Department of Clinical & Experimental Medecine, AOU Federico II — Naples
- AMC Medical Research BV, Department of Vascular Medicine — Amsterdam
California
- Los Angeles Orthopaedic Hospital — Los Angeles
District of Columbia
- Georgetown University — Washington D.C.
Illinois
- Rush Presbyterian St. Lukes — Chicago
Kentucky
- James Graham Brown Cancer Center — Louisville
Louisiana
- Tulane University — New Orleans
Maryland
- Johns Hopkins Medical Institutions — Baltimore
Massachusetts
- Brigham and Women´s Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2006-05-29 |
| Est. Completion | 2015-12-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00357656
The ClinicalTrials.gov registry entry for NCT00357656 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention — of which Recombinant Protein-Free Factor VIII (rAHF-PFM) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00357656 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00357656 about?
NCT00357656 is a clinical study titled "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". The purpose of this study is to compare the hemostatic efficacy and safety of continuous infusion versus intermittent bolus infusion in the peri- and post-operative setting, employing rAHF-PFM, a recombinant antihemophilic factor manufactured without added human or animal proteins, in previously tre...
What is the current status of trial NCT00357656?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 85 participants. The study started on 2006-05-29. Estimated completion is 2015-12-09.
What conditions does trial NCT00357656 study?
This clinical trial studies the following conditions: Hemophilia A. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00357656?
The interventions under investigation include: Recombinant Protein-Free Factor VIII (rAHF-PFM) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00357656?
This trial is sponsored by Baxalta now part of Shire, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00357656 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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