Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Factor VIII

Criteria

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.