Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A

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

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-08-31

Brief Summary

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This study is to describe the safety and efficacy of Xyntha® during the usual care setting.

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Detailed Description

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non probability sample

Conditions

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Hemophilia A

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Xyntha group

Xyntha will be administered according to physician's discretion.

Xyntha : coagulation factor IIIV (recombinant)

Intervention Type DRUG

Xyntha will be administered according to physician's discretion.

Interventions

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Xyntha : coagulation factor IIIV (recombinant)

Xyntha will be administered according to physician's discretion.

Intervention Type DRUG

Other Intervention Names

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Xyntha, MOROCTOCOG ALFA

Eligibility Criteria

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Inclusion Criteria

* Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement).
* Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from first approved date by KFDA, or who are planned to be newly prescribed Xyntha.

Exclusion Criteria

* Patients with a known history of hypersensitivity to original or reformulated Xyntha or any component of the product.
* Patients with a known history of hypersensitivity to hamster protein.
* Patients participating in an interventional trial of any investigational drug or device.

Eligible Sex

ALL

Accepts Healthy Volunteers

No