Back to resultsComparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
Primary Purpose
Hemophilia A
Status
Completed
Phase
Phase 1
Locations
Bulgaria
Study Type
Interventional
Intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia A focused on measuring BAY14-2222, Pharmacokinetics
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Maximum plasma concentration (Cmax) of BAY14-2222
Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01653639
Brief Title
Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
Keywords
BAY14-2222, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Intervention Description
50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)
Intervention Type
Biological
Intervention Name(s)
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Intervention Description
50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax) of BAY14-2222
Time Frame
Up to 48 hours
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
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