Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

Bayer

Status and phase

Completed

Phase 1

Conditions

Hemophilia A

Treatments

Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01653639

2012-001045-40 (EudraCT Number)

15495

Details and patient eligibility

About

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).

Enrollment

18 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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