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

Last updated on April 10, 2018

FOR MORE INFORMATION
Study Location
Yonsei Rehabilitation Clinic
Guro-gu, Seoul, 152-834 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01790828
Pfizer
Completed
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A

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Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha 'Registered' In Subjects With Hemophilia A
This study is to describe the safety and efficacy of Xyntha® during the usual care setting.
non probability sample
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Hemophilia A
Hemophilia A
Drug: Xyntha : coagulation factor IIIV (recombinant)
Xyntha will be administered according to physician's discretion.
Other Name: Xyntha, MOROCTOCOG ALFA
Xyntha group
Xyntha will be administered according to physician's discretion.
Intervention: Drug: Xyntha : coagulation factor IIIV (recombinant)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
August 2014
August 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01790828
B1831078
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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