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

NCT00484185 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 183

Last updated 2013-08-12

Study results available
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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

Conditions

  • Hemophilia B

Interventions

DRUG

BeneFIX (coagulation factor IX (recombinant))

BeneFIX will be administered according to physician's discretion.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00484185 on ClinicalTrials.gov