Status:
COMPLETED
Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to describe the pharmacokinetics (PK) of BAY94-9027(the test drug). Pharmacokinetics means that we will measure how well the study drug corrects the factor VIII levels in ...
Eligibility Criteria
Inclusion
- Male subjects with severe hemophilia A (documented plasma baseline Factor VIII level \<1 %)
- \>/= 18 but \</= 65 years of age
- Previously treated with Factor VIII concentrate(s) for a minimum of 150 exposure days (as supported by the subject's medical history)
- Immunocompetent with a CD4+ lymphocyte count \> 400/mm³
- Signed informed consent from subject
Exclusion
- Documented history of inhibitor to Factor VIII with a titer \>/= 0.6 BU (Biological Unit), by the Nijmegen modified assay. However, subjects with a maximum historical titer of \</= 1.0 BU with the classical Bethesda assay on a single measurement but with at least 3 subsequent successive negative results (\< 0.6 BU) thereafter are eligible.
- Unable to stop Factor VIII treatment to complete a minimum 72 hour washout
- Current evidence of inhibitor to Factor VIII with a titer \>/= 0.6 BU, measured at the time of screening
- Abnormal renal function (serum creatinine \> 1.5 times the upper limit of the normal range)
- Total bilirubin \> 1.5 times the upper limit of the normal range
- Active hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \> 2 times the upper limit of the normal range)
- Any concomitant coagulation disorder other than hemophilia A (including lupus anticoagulant)
- Platelet count \< 100,000/mm³
- Within the last 3 months prior to study entry or during the study will be treated with an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a interferon, steroids, rituximab, etc)
- Any subject who requires major surgery during study period. Minor procedures may be approved if discussed in advance with the medical expert.
Key Trial Info
Start Date :
October 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01184820
Start Date
October 13 2010
End Date
October 10 2011
Last Update
September 7 2018
Active Locations (4)
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1
Davis, California, United States, 95616
2
Boston, Massachusetts, United States, 02115-6195
3
Minneapolis, Minnesota, United States, 55455
4
Syracuse, New York, United States, 13210