check_circleStudy Completed

Hemophilia A

Bayer Identifier:

19096

ClinicalTrials.gov Identifier:

NCT03364998

EudraCT Number:

2017-003201-18

EU CT Number:

Not Available
BAY94-9027 PK study comparing to another long acting product

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 65 Years
  • - 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

  • - 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.

Trial summary

Enrollment Goal
18
Trial Dates
November 2017 - September 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EADSofia, 1756, Bulgaria

Primary Outcome

  • AUC from time 0 to the last data point
    Area under the concentration time profile curve.
    date_rangeTime Frame:
    Pre-Dose and up to 120 hours post dose

Trial design

Single dose, open label, randomized, crossover study in subjects with severe hemophilia A comparing pharmacokinetic parameters of BAY 94 9027 and Elocta
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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