Trial Condition(s):
Hemophilia A
Single dose study in subjects with severe Hemophilia A comparing pharmacokinetic parameters for BAY81-8973 and Advate
Bayer Identifier:
17608
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
The purpose of this study is to compare the
pharmacokinetics of BAY81-8973 and Advate after
intravenous administration.
Inclusion Criteria
-- Males, age 18 to 65 years - Subjects with Severe hemophilia A with a documented plasma FVIII level of <1% - ≥ 150 exposure days with FVIII concentrate(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 [ULN] range) - Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULN 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
Phase
1
Could I receive a placebo?
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Sofia, Bulgaria, 1756 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A comparing pharmacokinetic parameters for BAY81-8973 and Advate
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- AUC(0-tlast)Area under the blood concentration vs time curve from zero to the last data point > lower limit of quantificationTimeframe: Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment
Additional Information
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