Trial Condition(s):

Hemophilia A

BAY94-9027 PK study comparing to another long acting product

Bayer Identifier:

19096

ClinicalTrials.gov Identifier:

NCT03364998

EudraCT Number:

2017-003201-18

Study Completed

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
18
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

Sofia, Bulgaria, 1756

Status
Completed
 

Trial Design