NCT01599819

BAX 855 Dose-Escalation Safety Study

BAX 855 (PEGylated Recombinant Factor VIII): A Phase 1, Prospective, Open Label, Cross-Over, Dose-Escalation Study in Previously Treated Patients (PTPs) With Severe (FVIII < 1%) Hemophilia A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method	1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)
BIOLOGICAL	PEGylated Recombinant Factor VIII	1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)

Timeline

• Start date: 2011-09-30
• Primary completion: 2012-07-27
• Completion: 2012-07-27
• First posted: 2012-05-16
• Last updated: 2021-05-05

Locations

8 sites across 4 countries: Bulgaria, Germany, Japan, United Kingdom