Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01653639
First received: July 27, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653639

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01653639     History of Changes
Other Study ID Numbers: 15495, 2012-001045-40
Study First Received: July 27, 2012
Last Updated: January 8, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency

Keywords provided by Bayer:
BAY14-2222
Pharmacokinetics

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014