Brief Title
Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
Official Title
Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
Brief Summary
The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
AUC(0-tlast)
Condition
Hemophilia A
Intervention
BAY81-8973
Study Arms / Comparison Groups
BAY81-8973
Description: BAY81-8973 infusion to analyze pharmacokinetics
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
June 2015
Completion Date
December 2015
Primary Completion Date
July 2015
Eligibility 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.
Gender
Male
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT02483208
Organization ID
17608
Secondary IDs
2014-005173-36
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
February 2016