check_circleStudy 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
  •  -- 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

  •  -- 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
June 2015 - December 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment
    enhanced_encryption
    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
2

Additional Information

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