Trial Condition(s):
Hemophilia A
Comparative pharmacokinetic study of two different strengths of BAY14-2222
Bayer Identifier:
15495
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial 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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD Sofia, Bulgaria, 1756 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Biological/Vaccine
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Maximum plasma concentration (Cmax) of BAY14-2222Timeframe: 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 BAY14-2222Timeframe: Up to 48 hours
Additional Information
Copyright © Bayer
Powered by
