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

NCT ID: NCT00484185

Last Updated: 2013-08-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-06-30

Brief Summary

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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 Description

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The patients who meet the inclusion criteria will be enrolled consecutively.

Conditions

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Hemophilia B

Keywords

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Hemophilia B BeneFIX Safety Efficacy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

BeneFIX (coagulation factor IX (recombinant))

Intervention Type DRUG

BeneFIX will be administered according to physician's discretion.

Interventions

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BeneFIX (coagulation factor IX (recombinant))

BeneFIX will be administered according to physician's discretion.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3090X1-4403&StudyName=Post%20Marketing%20Surveillance%20To%20Observe%20Safety%20and%20Efficacy%20Of%20BeneFIX%20In%20Patients%20With%20Hemophilia%20B

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1821005

Identifier Type: -

Identifier Source: secondary_id

3090X1-4403

Identifier Type: -

Identifier Source: org_study_id