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

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

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sofia, 1756, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAY81-8973

Drug

BAY81-8973 infusion to analyze pharmacokinetics

ADVATE

Drug

Advate infusion to analyze pharmacokinetics.

Primary outcomes

AUC(0-tlast)

Time frame: 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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jun 26, 2015
Registry last updated: Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed