Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Conditions

Hemophilia A

Brief summary

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

Reding MT, Lalezari S, Kenet G, Di Minno G, Ducore J, Solms A, Shah A, Holme PA, Poulsen LH, Meijer K, Simpson M, Mancuso ME.

2024-08-202 citations

10.1007/s40268-024-00481-7

Correlations between von Willebrand Factor Antigen Levels and Factor VIII Pharmacokinetics Are Similar across Different FVIII Products in Patients with Severe Hemophilia A

Alfonso Iorio, Monika Maas Enriquez, Heinz Delesen, Alexander Solms, Stacy E. Croteau et al. (6 authors)

Blood2019-11-131 citations

10.1182/blood-2019-127046

Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A.

Shah A, Solms A, Garmann D, Katterle Y, Avramova V, Simeonov S, Lissitchkov T.

2017-09-0129 citations

10.1007/s40262-016-0492-2

Interventions

DRUGBAY81-8973

BAY81-8973 infusion to analyze pharmacokinetics

DRUGAdvate

Advate infusion to analyze pharmacokinetics.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
AUC(0-tlast)	Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment	Area under the blood concentration vs time curve from zero to the last data point \> lower limit of quantification

Countries

Bulgaria

Outcome results

None listed