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COMPLETED Phase 3

Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

NCT00243659 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 30 participants
Start Date 2006-04
Est. Completion 2008-06
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00243659

The ClinicalTrials.gov registry entry for NCT00243659 describes a study currently listed as completed. It is categorized as Phase 3, 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 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 31 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 ReFacto AF 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: NCT00243659 reports 17 study locations spanning 7 distinct geographic areas — top geographies include Other, Michigan, Pennsylvania. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00243659?

The interventions under investigation include: ReFacto AF (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00243659?

This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial