You are here

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

Last updated on October 12, 2019

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief TitlePost Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
Official TitlePost Marketing Surveillance To Observe Safety And Efficacy Of BeneFIX In Patients With Hemophilia B
Brief Summary

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

Detailed DescriptionThe patients who meet the inclusion criteria will be enrolled consecutively.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationHemophilia B (congenital factor IX deficiency or Christmas disease).
ConditionHemophilia B
InterventionDrug: BeneFIX (coagulation factor IX (recombinant))
BeneFIX will be administered according to physician's discretion.
Study Groups/Cohorts1
Intervention: Drug: BeneFIX (coagulation factor IX (recombinant))
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: April 11, 2013)
183
Original Enrollment
 (submitted: June 7, 2007)
600
Actual Study Completion DateJune 2012
Actual Primary Completion DateJune 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00484185
Other Study ID Numbers3090X1-4403
B1821005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now