Status:
COMPLETED
BAY94-9027 PK Study Comparing to Another Long Acting Product
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03364998
Start Date
November 30 2017
End Date
September 28 2018
Last Update
September 9 2019
Active Locations (1)
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1
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia, Bulgaria, 1756