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NCT03364998 Clinical Trial

BAY94-9027 PK Study Comparing to Another Long Acting Product

Hemophilia A Clinical Trial

Official title:
Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03364998
Other study ID # 19096
Secondary ID 2017-003201-18
Status Completed
Phase Phase 1
First received
Last updated
Start date November 30, 2017
Est. completion date September 28, 2018

Study information
Verified date September 2019
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date September 28, 2018
Est. primary completion date January 25, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Bulgaria SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD Sofia

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Bulgaria, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC from time 0 to the last data point Area under the concentration time profile curve. Pre-Dose and up to 120 hours post dose
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