At a glance
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Post Marketing Surveillance To Observe Safety And Efficacy Of BeneFIX In Patients With Hemophilia B
In Brief
An observational study evaluating BeneFIX (coagulation factor IX (recombinant)) for Hemophilia B. Completed, enrolled 183 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
BeneFIX will be administered according to physician's discretion.