N/A
Completed N=314
BeneFIX Drug Use Results Survey [All-Case Surveillance]
Source: ClinicalTrials.gov NCT01154231 ↗Enrolled (actual)
314
Serious AEs
1.6%
Results posted
Apr 2017
Primary outcomePrimary: Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy — 2.00 Bleeding events/year
Summary
The survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch.
1. Occurrence status of adverse events
2. Factors that may influence the safety
3. Efficacy In addition, the following occurrence statuses will be investigated as priority items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic reaction, and Thrombosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy |
2.00 | — |
| PRIMARY Number of Administrations Required for Hemostasis for Bleeding Events |
1.8 | — |
| SECONDARY Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes |
93.7 | — |
Eligibility Criteria
Inclusion Criteria
- All patients with hemophilia B scheduled to receive treatment with BeneFIX will be eligible for the surveillance.
- No patient will be excluded because of prior inhibitor history; however, complete patient history and demographics will be collected.
Exclusion Criteria
- Patients not administered BeneFIX.
Data sourced from ClinicalTrials.gov (NCT01154231). 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.