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Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe

Last updated on April 9, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Congenital Factor VIII Deficiency, Congenital Factor 8 Deficiency, Autosomal Hemophilia A, Classic Hemophilia, Congenital Hemophilia A
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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To be eligible to enroll in this study, the study subjects will have to meet all the
following inclusion criteria:

1. Hemophilia A (congenital factor VIII deficiency) patients who have been administered
according to the indication of the product 1) Control and prevention of bleeding
episodes and for routine and surgical prophylaxis in patients with hemophilia A
(congenital factor VIII deficiency) 2) This drug does not contain von Willebrand
factor and, therefore, is not indicated in von Willebrand's disease

2. Those who have been administered the Xyntha Solofuse prefilled syringe at least once -

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Patients who satisfy the following criteria are not included in the study according to the
local labeling:

1. Patients who have a history of hypersensitivity to the Xyntha Solofuse prefilled
syringe or the ingredients of this drug.

2. Patients who have a history of hypersensitivity to hamster proteins.

3. Patients who have bleeding disorders other than hemophilia A.

4. Patients who have a history of FVIII inhibitors, or currently have or are suspected of
having FVIII inhibitors. In case inhibitor titers quantified in Bethesda Units in the
laboratory test results are within the normal laboratory range or at least 0.6 BU/mL.
If laboratory tests cannot be performed, the investigator will determine whether or
not inhibitors exist based on the clinical assessment results that show a decrease in
efficacy of the replacement of FVIII (e.g. bleeding at least once, if the replacement
of anti-bleeding agents is needed to be administered, and if frequency or dosage of
replacement FVIII therapy needs to be increased).

5. Use of immunomodulatory therapy. (e.g. intravenous injection of immunoglobulin, use of
regular systemic corticosteroids, cyclosporine, and mediators of anti-TNF-?)

NCT03034044
Pfizer
Completed
Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe

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[email protected]

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