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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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BAY81-8973

BAY81-8973 infusion to analyze pharmacokinetics

Group Type EXPERIMENTAL

BAY81-8973

Intervention Type DRUG

BAY81-8973 infusion to analyze pharmacokinetics

Advate

Advate infusion to analyze pharmacokinetics.

Group Type OTHER

Advate

Intervention Type DRUG

Advate infusion to analyze pharmacokinetics.

Interventions

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BAY81-8973

BAY81-8973 infusion to analyze pharmacokinetics

Intervention Type DRUG

Advate

Advate infusion to analyze pharmacokinetics.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No