Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01653639
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : January 10, 2014
Information provided by (Responsible Party):

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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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)
Study Start Date : July 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of BAY14-2222 [ Time Frame: Up to 48 hours ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01653639

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

Additional Information:
Responsible Party: Bayer Identifier: NCT01653639     History of Changes
Other Study ID Numbers: 15495
2012-001045-40 ( EudraCT Number )
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 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