Trial Condition(s):

Hemophilia A

Comparative pharmacokinetic study of two different strengths of BAY14-2222

Bayer Identifier:

15495

ClinicalTrials.gov Identifier:

NCT01653639

EudraCT Number:

2012-001045-40

Study Completed

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
18
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

Sofia, Bulgaria, 1756

Status
Completed
 

Trial Design