Hemophilia A
Conditions
Brief 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.
Interventions
1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)
BIOLOGICALPEGylated Recombinant Factor VIII
1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)
Sponsors
Baxter Innovations GmbH
Baxalta now part of Shire
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The subject is male and is 18 to 65 years of age at the time of screening * The subject has severe hemophilia A (factor VIII level \< 1%) * The subject was previously treated with plasma-derived factor VIII (FVIII) concentrates or recombinant FVIII for at least 150 exposure days (EDs)
Exclusion criteria
* The subject has a detectable FVIII inhibitor at screening, with a titer \>= 0.6 BU * The subject has a documented history of FVIII inhibitors with a titer \>= 0.4 BU at any time prior to screening * The subject has a known hypersensitivity towards mouse or hamster proteins or to polyethylene glycol (PEG)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious and non-serious AEs | 4 weeks after infusion with BAX 855 and ADVATE |
Countries
Bulgaria, Germany, Japan, United Kingdom
Outcome results
None listed