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

Bayer

Status and phase: Completed; Phase 1

Conditions: Hemophilia A

Treatments: Drug: BAY81-8973; Drug: Advate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02483208

2014-005173-36 (EudraCT Number)

17608

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

BAY81-8973

Experimental group

Description:

BAY81-8973 infusion to analyze pharmacokinetics

Treatment:

Drug: BAY81-8973

Advate

Other group

Description:

Advate infusion to analyze pharmacokinetics.

Treatment:

Drug: Advate