Brief Title
Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
Official Title
Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A to Compare the Bioavailability of 2 Different Strengths of Kogenate FS (BAY14-2222)
Brief Summary
This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Maximum plasma concentration (Cmax) of BAY14-2222
Condition
Hemophilia A
Intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Study Arms / Comparison Groups
Arm 1
Description:
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
Biological
Estimated Enrollment
18
Start Date
July 2012
Completion Date
December 2012
Primary Completion Date
December 2012
Eligibility Criteria
Inclusion Criteria: - Males, age 18 to 65 years - Subjects with Severe hemophilia A with a documented plasma FVIII level of <1% - >/= 150 ED (exposure days) with FVIII concentrates(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 range) - Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x the upper limit of normal 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
NCT01653639
Organization ID
15495
Secondary IDs
2012-001045-40
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
January 2014