Study Evaluating The Safety Of Xyntha In Usual Care Settings

Study Overview
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Brief Summary
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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.

Detailed Description
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The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF. The termination of this study has no impact on subject safety or well being. The decision to terminate the trial was not based on any safety concerns.

Official Title
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A Postauthorization Safety Surveillance Study Of Xyntha In Usual Care Settings

Conditions
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Hemophilia A

Intervention / Treatment
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* Biological: Moroctocog alfa(AF-CC)
* Procedure: Blood draw for laboratory testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Moroctocog alfa(AF-CC)<br> | Biological: Moroctocog alfa(AF-CC)<br>* Dosing is at the discretion of the investigator during the study<br>* Other names: Xyntha;Procedure: Blood draw for laboratory testing<br>* Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Factor VIII (FVIII) Inhibitor Development | FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory. | Month 24 or early withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemophilia, hemophilia A, ReFacto, Xyntha, moroctocog alfa, bleeding disorder