Study Completed

Hemophilia A

Bayer Identifier:

17608

ClinicalTrials.gov Identifier:

NCT02483208

EudraCT Number:

2014-005173-36

EU CT Number:

Not Available

Single dose study in subjects with severe Hemophilia A comparing pharmacokinetic parameters for BAY81-8973 and Advate

Trial purpose

The purpose of this study is to compare the
pharmacokinetics of BAY81-8973 and Advate after
intravenous administration.

Key Participants Requirements

Sex

Male

Age

18 - 65 Years

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

Trial Dates

June 2015 - December 2015

Phase

Phase 1

Could I Receive a placebo

Products

Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Sofia, 1756, Bulgaria

Primary Outcome

AUC(0-tlast)
Area under the blood concentration vs time curve from zero to the last data point > lower limit of quantification
Time Frame:
Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment
Safety Issue:
No

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

Additional Information

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