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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Drainage fluid volume was to be measured cumulatively and recorded every 8 hours ± 30 minutes during the first 24 hours following surgery. Unit of measure: Tera per Liter is the PRBC concentration in 10\^12 units per 1 liter of drainage fluid.

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
Baxalta now part of Shire

74 total trials

What the finished NCT00357656 record still lists

NCT00357656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, roughly in line with the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target.

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 names 20 study sites across 11 states, led by 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.

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 NCT00357656's enrollment target sits among peer trials

85 15th of 42 higher than 28 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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Related registry views

Source: ClinicalTrials.gov NCT00357656, the US trial registry maintained by the National Library of Medicine. NCT00357656 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.