Status:
TERMINATED
Study Evaluating The Safety Of Xyntha In Usual Care Settings
Lead Sponsor:
Pfizer
Conditions:
Hemophilia A
Eligibility:
MALE
12+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately...
Detailed Description
The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF. The termination of this study has no impact on subject s...
Eligibility Criteria
Inclusion
- Male patients 12 years of age and older.
- Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII replacement products.
- Treatment history of 150 or greater exposure days to any FVIII products prior to Enrollment visit.
- Negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy.
Exclusion
- Bleeding disorder other than hemophilia A.
- Inhibitor titer greater than or equal to 0.6 BU during screening except for patients on immune tolerance induction therapy.
- Immunomodulatory therapy during screening period.
- Known hypersensitivity to hamster protein.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00765726
Start Date
February 1 2009
End Date
August 1 2011
Last Update
January 20 2012
Active Locations (6)
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1
Pfizer Investigational Site
Los Angeles, California, United States, 90007
2
Pfizer Investigational Site
Washington D.C., District of Columbia, United States, 20010
3
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
4
Pfizer Investigational Site
East Lansing, Michigan, United States, 48823