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NCT00357656 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Hemophilia A, sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 4
Development phase
85
Enrollment target
20
Study locations

NCT00357656 is a Phase 4 study of Hemophilia A that has completed, run by Baxalta now part of Shire. The registered enrollment target is 85 participants, roughly in line with the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target. The trial reports 20 study locations across 11 states.

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The verdict

NCT00357656, a Phase 4 study of Hemophilia A, has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 4
Development phase
85 participants
Enrollment target
20
Study locations

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

Hemophilia A

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

FieldValue
Enrollment Target 85 participants
Start Date 2006-05-29
Est. Completion 2015-12-09
Phase Phase 4

Sponsor

Baxalta now part of Shire

74 total trials

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What the Registry Record Tells You About NCT00357656

The ClinicalTrials.gov registry entry for NCT00357656 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.

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.

NCT00357656 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, District of Columbia.

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.

What interventions are being tested in trial NCT00357656?

The interventions under investigation include: Recombinant Protein-Free Factor VIII (rAHF-PFM) (DRUG).

Who is sponsoring clinical trial NCT00357656?

This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.