N/A
Completed N=58
Post Marketing Observational Study of Reformulated BeneFIX
Source: ClinicalTrials.gov NCT00835068 ↗Enrolled (actual)
58
Serious AEs
19.0%
Results posted
Sep 2014
Primary outcomePrimary: Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment — 1; 1; 0; 1 participants
Summary
The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment |
1; 1; 0; 1 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment |
26; 10; 1; 0 | — |
| PRIMARY Number of Participants With Events of Special Interest |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Bleeding Episodes |
261; 695 | — |
| SECONDARY Number of Bleeding Episodes Requiring Treatment by Injection |
144; 515; 63; 89; 21; 35 | — |
| SECONDARY Total Consumption of BeneFIX |
434751.0; 15000.0 | — |
| SECONDARY Subjective Assessment of Efficacy by Participant |
4; 19; 19; 0; 0; 4 | — |
| SECONDARY Dose Per Injection of BeneFIX |
45.3; 49.0 | — |
| SECONDARY Subjective Assessment of Efficacy by Physician |
17; 23; 2; 0; 10; 29 | — |
| SECONDARY Subjective Assessment of Ease of Use by Participant |
5; 17; 19; 1; 0; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX.
- Subjects who have dated and signed the informed consent form.
Exclusion Criteria
- Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX.
- Participation in the European prospective registry of patients with Hemophilia B treated with BeneFIX (Wyeth protocol 3090A-101039).
Data sourced from ClinicalTrials.gov (NCT00835068). 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.