Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
NCT ID: NCT01653639
Last Updated: 2014-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2012-07-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm 1
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)
Arm 2
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)
Interventions
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Recombinant Factor VIII (Kogenate FS, BAY14-2222)
50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Sofia, , Bulgaria
Countries
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Other Identifiers
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2012-001045-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15495
Identifier Type: -
Identifier Source: org_study_id
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