BAY94-9027 PK Study Comparing to Another Long Acting Product

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

2017-11-30

Study Completion Date

2018-09-28

Brief Summary

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The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta 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

Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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BAY94-9027 and Elocta

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

Group Type EXPERIMENTAL

Damoctocog (Jivi, BAY94-9027)

Intervention Type DRUG

60 international units (IU)/kg, given as a 10 minute injection, 1 dose

Elocta

Intervention Type DRUG

60 IU/kg, given as a 10 minute injection, 1 dose

Elocta and BAY94-9027

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

Group Type EXPERIMENTAL

Damoctocog (Jivi, BAY94-9027)

Intervention Type DRUG

60 international units (IU)/kg, given as a 10 minute injection, 1 dose

Elocta

Intervention Type DRUG

60 IU/kg, given as a 10 minute injection, 1 dose

Interventions

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Damoctocog (Jivi, BAY94-9027)

60 international units (IU)/kg, given as a 10 minute injection, 1 dose

Intervention Type DRUG

Elocta

60 IU/kg, given as a 10 minute injection, 1 dose

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/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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No