check_circleStudy Completed

Hemophilia A

Bayer Identifier:

15495

ClinicalTrials.gov Identifier:

NCT01653639

EudraCT Number:

2012-001045-40

EU CT Number:

Not Available
Comparative pharmacokinetic study of two different strengths of BAY14-2222

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).

Key Participants Requirements

Sex

Male

Age

18 - 65 Years
  • - 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
  • - 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
July 2012 - December 2012
Phase
Phase 1
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EADSofia, 1756, Bulgaria

Primary Outcome

  • Maximum plasma concentration (Cmax) of BAY14-2222
    date_rangeTime Frame:
    Up to 48 hours
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    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
    date_rangeTime Frame:
    Up to 48 hours
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    Safety Issue:
    No

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

Additional Information

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