Brief Title
BAY94-9027 PK Study Comparing to Another Long Acting Product
Official Title
Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta
Brief Summary
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
AUC from time 0 to the last data point
Condition
Hemophilia A
Intervention
Damoctocog (Jivi, BAY94-9027)
Study Arms / Comparison Groups
BAY94-9027 and Elocta
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
November 30, 2017
Completion Date
September 28, 2018
Primary Completion Date
January 25, 2018
Eligibility Criteria
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.
Gender
Male
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT03364998
Organization ID
19096
Secondary IDs
2017-003201-18
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
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Verification Date
September 2019