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

TerminatedPhase 3

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Conditions: Hemophilia A

Interventions: Moroctocog alfa

This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC)) in male patients less than 6 years old. Annualized bleeding rates and physician / caregiver assessments of responses to treatment will be characterized. FVIII inhibitor levels will be assessed throughout the study.

Eligibility overview

Sex: MALE

Age: 0 Years to 5 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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:

* 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.