Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
Phase 1
Completed
- Conditions
- Hemophilia A
- Interventions
- Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Registration Number
- NCT01653639
- Lead Sponsor
- Bayer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 2 Recombinant Factor VIII (Kogenate FS, BAY14-2222) - Arm 1 Recombinant Factor VIII (Kogenate FS, BAY14-2222) -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222 Up to 48 hours Maximum plasma concentration (Cmax) of BAY14-2222 Up to 48 hours
- Secondary Outcome Measures
Name Time Method