BAY94-9027 PK Study Comparing to Another Long Acting Product

• Status: Completed
• Trial end date: 2018-09-28
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta 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/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.