BAY94-9027 PK Study Comparing to Another Long Acting Product

Phase 1

Completed

• Conditions: Hemophilia A
• Interventions: Drug: Damoctocog (Jivi, BAY94-9027); Drug: Elocta

• Registration Number: NCT03364998
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-30
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-07
• Primary Completion: 2018-01-25
• Study Completion: 2018-09-28
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BAY94-9027 and Elocta	Damoctocog (Jivi, BAY94-9027)	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
BAY94-9027 and Elocta	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
Elocta and BAY94-9027	Damoctocog (Jivi, 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
Elocta and BAY94-9027	Elocta	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

Primary Outcome Measures

Name	Time	Method
AUC from time 0 to the last data point	Pre-Dose and up to 120 hours post dose	Area under the concentration time profile curve.

Trial Locations

Locations (1)

SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD; 🇧🇬 Sofia, Bulgaria