NCT00243386

Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A

Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (ADVATE rAHF-PFM): A Phase 4 Study Comparing Two Prophylactic Regimens in Subjects With Severe or Moderately Severe Hemophilia A

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 7 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this randomized, two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6 hours; actual dose determined by Baxter utilizing an algorithm and the patient's pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled patients will be treated originally on demand for a period of 6 months and then they will be randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of 12 months +/- 2 weeks.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	Antihemophilic factor, recombinant, manufactured protein-free	Standard prophylaxis: 20-40 IU/kg every 48+/-6 hours, actual dose determined by investigator
DRUG	Antihemophilic factor, recombinant, manufactured protein-free	PK-driven prophylaxis: 20-80 IU/kg every 72+/-6 hours, actual dose determined by Baxter using an algorithm and the patient´s pharmacokinetic data

Timeline

• Start date: 2006-01-04
• Primary completion: 2010-06-16
• Completion: 2010-06-16
• First posted: 2005-10-24
• Last updated: 2021-05-19
• Results posted: 2012-11-20

Locations

29 sites across 10 countries: United States, Austria, Czechia, Greece, Hungary, Italy, Poland, Russia, Slovenia, United Kingdom