Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
- Registration Number
- NCT02483208
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
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/mm3
- Abnormal renal function (serum creatinine >2 times the upper limit of the normal [ULN] range)
- Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BAY81-8973 BAY81-8973 BAY81-8973 infusion to analyze pharmacokinetics Advate Advate Advate infusion to analyze pharmacokinetics.
- Primary Outcome Measures
Name Time Method AUC(0-tlast) Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment Area under the blood concentration vs time curve from zero to the last data point \> lower limit of quantification
- Secondary Outcome Measures
Name Time Method