Hemophilia A
Conditions
Brief summary
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
Interventions
DRUGDamoctocog (Jivi, BAY94-9027)
60 international units (IU)/kg, given as a 10 minute injection, 1 dose
DRUGElocta
60 IU/kg, given as a 10 minute injection, 1 dose
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males, age 18 to 65 years. * Subjects with Severe Hemophilia A with a documented plasma FVIII level of \< 1% * ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records
Exclusion criteria
* Evidence of current or past inhibitor antibody: * History of any congenital or acquired coagulation disorders other than hemophilia A. * Platelet count \<75,000/mm\*3. * Abnormal renal function (serum creatinine \>2 x the upper limit of the normal range). * Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase \>5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC from time 0 to the last data point | Pre-Dose and up to 120 hours post dose | Area under the concentration time profile curve. |
Countries
Bulgaria
Outcome results
None listed