Study Evaluating The Safety Of Xyntha In Usual Care Settings

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-08-31

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.

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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.

Conditions

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Hemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moroctocog alfa(AF-CC)

Group Type OTHER

Moroctocog alfa(AF-CC)

Intervention Type BIOLOGICAL

Dosing is at the discretion of the investigator during the study

Blood draw for laboratory testing

Intervention Type PROCEDURE

Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies

Interventions

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Moroctocog alfa(AF-CC)

Dosing is at the discretion of the investigator during the study

Intervention Type BIOLOGICAL

Blood draw for laboratory testing

Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies

Intervention Type PROCEDURE

Other Intervention Names

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Xyntha

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.

Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No