Clinical trial NCT00484185: Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
Official title: Post Marketing Surveillance To Observe Safety And Efficacy Of BeneFIX In Patients With Hemophilia B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia B
Keywords: Hemophilia B
BeneFIX
Safety
Efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-08
Enrollment: 183
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemophilia B (congenital factor IX deficiency or Christmas disease).

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

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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) According to Baseline Characteristics
timeFrame: Baseline up to 6 months
measure: Number of Participants With Adverse Events (AEs) According to Severity
timeFrame: Baseline up to 6 months
measure: Number of Participants With Action Taken in Response to Adverse Events (AEs)
timeFrame: Baseline up to 6 months
measure: Number of Participants With Adverse Events (AEs) According to Seriousness
timeFrame: Baseline up to 6 months
measure: Number of Participants With Outcome in Response to Adverse Events (AEs)
timeFrame: Baseline up to 6 months
measure: Number of Participants With Adverse Events (AEs) by Relationship
timeFrame: Baseline up to 6 months
measure: Number of Participants With Unexpected Adverse Events (AEs)
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Mean Annualized Bleeding Rate (ABR)
timeFrame: Baseline up to 6 months
measure: Number of Responses to On-demand Treatment With Study Medication
timeFrame: Baseline up to 6 months
measure: Mean Number of Infusion of Study Medication
timeFrame: Baseline up to 6 months
measure: Mean Number of Breakthrough Bleeds Within 48 Hours of Study Medication
timeFrame: Baseline up to 6 months
measure: Average Infusion Dose of Study Medication
timeFrame: Baseline up to 6 months
measure: Total Infusion of Study Medication
timeFrame: Baseline up to 6 months
measure: Percentage of Participants With Efficacy Evaluation
timeFrame: Baseline up to 6 months
Other outcomes:
measure: Duration of Adverse Events (AEs)
timeFrame: Baseline up to 6 months
measure: Number of Participants Who Discontinued the Study Due to Adverse Events (AEs)
timeFrame: Baseline up to 6 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: