NCT00289536

Dose-Response 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 to Determine the Pharmacokinetic Response of Patients Diagnosed With Severe Hemophilia A to Different Doses of ADVATE rAHF-PFM

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase \[IU/dL\] per IU/kg infused) and major single-infusion pharmacokinetic parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not have received treatment with a factor VIII concentrate for at least 3 days. Blood samples will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion. A washout period of at least 3 days, but no more than 30 days between the last blood draw and the next infusion will be observed. During participation, subjects will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII concentrate. A secondary objective is to investigate the relationship between pharmacokinetic parameters at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and von Willebrand factor antigen at baseline.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Antihemophilic factor, recombinant, manufactured protein-free	15 IU/kg rAHF-PFM
BIOLOGICAL	Antihemophilic factor, recombinant, manufactured protein-free	30 IU/kg rAHF-PFM
BIOLOGICAL	Antihemophilic factor, recombinant, manufactured protein-free	50 IU/kg rAHF-PFM

Timeline

• Start date: 2006-02-02
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2006-02-10
• Last updated: 2021-06-10
• Results posted: 2011-01-13

Locations

8 sites across 1 country: United States