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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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The study was terminated on 22 Sept 2009 due to competition with another Wyeth study for a similar patient population. The decision to terminate the trial was not based on any safety issues.

Conditions

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Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open label

Group Type OTHER

Moroctocog alfa

Intervention Type BIOLOGICAL

Patients will receive Moroctocog alfa according to their investigator's prescription.

Interventions

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Moroctocog alfa

Patients will receive Moroctocog alfa according to their investigator's prescription.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

5 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No