BAY94-9027 PK Study Comparing to Another Long Acting Product

Bayer

Status and phase: Completed; Phase 1

Conditions: Hemophilia A

Treatments: Drug: Damoctocog (Jivi, BAY94-9027); Drug: Elocta

Study type: Interventional

Funder types: Industry

Identifiers

NCT03364998

19096

2017-003201-18 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta 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/mm*3.
• Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
• Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >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

BAY94-9027 and Elocta

Experimental group

Description:

Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment

Treatment:

Drug: Damoctocog (Jivi, BAY94-9027)

Drug: Elocta

Elocta and BAY94-9027

Experimental group

Description:

Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment

Treatment:

Drug: Damoctocog (Jivi, BAY94-9027)

Drug: Elocta