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Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
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
0-5
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male patients less than 6 years of age with moderately severe to severe hemophilia A
(FVIII less than or equal to 2%).

- Treatment history of less than 50 exposure days to prior recombinant or plasma-derived
FVIII replacement products.

- Not receiving treatment for HIV or hepatitis infection, or the patient is on a stable
antiviral regimen at the time of enrollment in the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Presence of any bleeding disorder in addition to hemophilia A.

- Inhibitor titer of greater than or equal to 5 Bethesda Units (BU) at screening.

- Treated with immunomodulatory therapy during the screening period

- Treatment history of more than 5 exposure days (ED) to Xyntha.

- Known hypersensitivity to hamster protein.

NCT00759655
Pfizer
Terminated
Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age

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

Pfizer Clinical Trials Contact Center

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[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

BY EMAIL

Contact

[email protected]

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