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:

NCT02483208

EudraCT Number:

2014-005173-36

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
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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
LocationsStatus
Locations

Investigative Site

Sofia, Bulgaria, 1756

Status
Completed
 

Trial Design