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Study Evaluating The Safety Of Xyntha In Usual Care Settings

Last updated on February 23, 2019

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Study Location
Pfizer Investigational Site
Los Angeles, California, 90007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00765726
Pfizer
Terminated
Study Evaluating The Safety Of Xyntha In Usual Care Settings

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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