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BAY94-9027 PK Study Comparing to Another Long Acting Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03364998
Recruitment Status : Completed
First Posted : December 7, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Hemophilia A Drug: Damoctocog (Jivi, BAY94-9027) Drug: Elocta Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : September 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: 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
Drug: Damoctocog (Jivi, BAY94-9027)
60 international units (IU)/kg, given as a 10 minute injection, 1 dose

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

Experimental: 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
Drug: Damoctocog (Jivi, BAY94-9027)
60 international units (IU)/kg, given as a 10 minute injection, 1 dose

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




Primary Outcome Measures :
  1. AUC from time 0 to the last data point [ Time Frame: Pre-Dose and up to 120 hours post dose ]
    Area under the concentration time profile curve.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364998


Locations
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Bulgaria
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia, Bulgaria, 1756
Sponsors and Collaborators
Bayer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03364998    
Other Study ID Numbers: 19096
2017-003201-18 ( EudraCT Number )
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants