NCT00484185

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Hemophilia B

Interventions

Type	Name	Description
DRUG	BeneFIX (coagulation factor IX (recombinant))	BeneFIX will be administered according to physician's discretion.

Timeline

• Start date: 2007-08-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2007-06-08
• Last updated: 2013-08-12
• Results posted: 2013-08-12

Locations

1 site across 1 country: South Korea