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

Pfizer

Status: Completed

Conditions: Hemophilia A

Treatments: Drug: Xyntha : coagulation factor IIIV (recombinant)

Study type: Observational

Funder types: Industry

Identifiers

NCT01790828

B1831078

Details and patient eligibility

About

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

Full description

non probability sample

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 1 patient group

Xyntha group

Description:

Xyntha will be administered according to physician's discretion.

Treatment:

Drug: Xyntha : coagulation factor IIIV (recombinant)