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Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Seoul, , 137-882 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
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 original or reformulated
BeneFIX for hemophilia B (congenital factor IX deficiency or Christmas disease) from
first approved date by KFDA, or who are planned to be newly prescribed BeneFIX (for
example, patients switching from pdFIX to BeneFIX).

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 BeneFIX
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.

NCT00484185
Pfizer
Completed
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B

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Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
Post Marketing Surveillance To Observe Safety And Efficacy Of BeneFIX In Patients With Hemophilia B

To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including:

1) Unknown adverse reactions, especially serious adverse reactions; 2) Changes in the incidences of adverse reactions under the routine drug uses.

3) Factors that may affect the safety of the drug 4) Factors that may affect the effectiveness of the drug

The patients who meet the inclusion criteria will be enrolled consecutively.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Hemophilia B (congenital factor IX deficiency or Christmas disease).
Hemophilia B
Drug: BeneFIX (coagulation factor IX (recombinant))
BeneFIX will be administered according to physician's discretion.
1
Intervention: Drug: BeneFIX (coagulation factor IX (recombinant))
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
June 2012
June 2012   (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 original or reformulated BeneFIX for hemophilia B (congenital factor IX deficiency or Christmas disease) from first approved date by KFDA, or who are planned to be newly prescribed BeneFIX (for example, patients switching from pdFIX to BeneFIX).

Exclusion Criteria:

  • Patients with a known history of hypersensitivity to original or reformulated BeneFIX 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
 
 
NCT00484185
3090X1-4403
B1821005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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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