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Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: July 27, 2012
Last updated: January 8, 2014
Last verified: January 2014
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).

Condition Intervention Phase
Hemophilia A Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Maximum plasma concentration (Cmax) of BAY14-2222 [ Time Frame: Up to 48 hours ]
  • Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222 [ Time Frame: Up to 48 hours ]

Enrollment: 18
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)
Experimental: Arm 2 Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01653639

Sofia, Bulgaria, 1756
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01653639     History of Changes
Other Study ID Numbers: 15495
2012-001045-40 ( EudraCT Number )
Study First Received: July 27, 2012
Last Updated: January 8, 2014

Keywords provided by Bayer:

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants processed this record on August 23, 2017