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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
GroupInterventionDescription
Arm 2Recombinant Factor VIII (Kogenate FS, BAY14-2222)-
Arm 1Recombinant Factor VIII (Kogenate FS, BAY14-2222)-
Primary Outcome Measures
NameTimeMethod
Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222Up to 48 hours
Maximum plasma concentration (Cmax) of BAY14-2222Up to 48 hours
Secondary Outcome Measures
NameTimeMethod
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