Study Evaluating The Safety Of Xyntha In Usual Care Settings
Stopped early · Phase 4
Conditions studied: Hemophilia A
In brief
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 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.
Key facts
- Study ID
- NCT00765726
- Run by
- Pfizer
- People needed
- 12
- Starts
- 2009-02-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2012-01-20
Who can join
Age: 12 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Los Angeles, California, United States
- Pfizer Investigational Site — Washington D.C., District of Columbia, United States
- Pfizer Investigational Site — Detroit, Michigan, United States
- Pfizer Investigational Site — East Lansing, Michigan, United States
- Pfizer Investigational Site — Dayton, Ohio, United States
- Pfizer Investigational Site — Christchurch, New Zealand, New Zealand
Full record on ClinicalTrials.gov
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