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

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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)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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