N/A
Completed N=183
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
Source: ClinicalTrials.gov NCT00484185 ↗Enrolled (actual)
183
Serious AEs
2.3%
Results posted
Aug 2013
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) According to Baseline Characteristics — 0; 1; 2; 3 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) According to Baseline Characteristics |
0; 1; 2; 3; 1; 2 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) According to Severity |
6; 2; 4 | — |
| PRIMARY Number of Participants With Action Taken in Response to Adverse Events (AEs) |
— | — |
| PRIMARY Number of Participants With Adverse Events (AEs) According to Seriousness |
4; 5 | — |
| PRIMARY Number of Participants With Outcome in Response to Adverse Events (AEs) |
— | — |
| PRIMARY Number of Participants With Adverse Events (AEs) by Relationship |
9; 1 | — |
| PRIMARY Number of Participants With Unexpected Adverse Events (AEs) |
— | — |
| SECONDARY Mean Annualized Bleeding Rate (ABR) |
84.25 | — |
| SECONDARY Number of Responses to On-demand Treatment With Study Medication |
1145; 788; 65; 0 | — |
| SECONDARY Mean Number of Infusion of Study Medication |
2.25 | — |
| SECONDARY Mean Number of Breakthrough Bleeds Within 48 Hours of Study Medication |
0.27 | — |
| SECONDARY Average Infusion Dose of Study Medication |
38.79; 32.92 | — |
| SECONDARY Total Infusion of Study Medication |
50356.11 | — |
| SECONDARY Percentage of Participants With Efficacy Evaluation |
81.82; 18.18; 0.00; 0.00 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00484185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.