N/A
N=80
Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
Hemophilia B
Bottom Line
View on ClinicalTrials.gov: NCT00714415 ↗Enrolled (actual)
80
Serious AEs
46.3%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 19; 49; 8; 29 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- BeneFIX (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
19; 49; 8; 29 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
2; 8; 1; 2 | — |
| PRIMARY Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay |
1; 3 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) of Special Interest |
0; 0 | — |
| PRIMARY Investigator Assessment of Treatment Tolerability of Participants |
16; 35; 7; 18; 0; 1 | — |
| PRIMARY Participant Assessment of Treatment Tolerability |
16; 37; 6; 14; 0; 1 | — |
| SECONDARY Mean Total Number of Bleeding Episodes in Participants |
16.7; 17.6 | — |
| SECONDARY Mean Total Number of Bleeding Episodes Per Year in Participants |
4.7; 4.2 | — |
| SECONDARY Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work |
4; 7; 9; 20; 2; 7 | — |
| SECONDARY Investigator Assessment of Treatment Efficacy of Participants |
10; 24; 11; 30; 1; 0 | — |
| SECONDARY Investigator Assessment of Treatment Handling of Participants |
13; 34; 10; 20; 0; 0 | — |
| SECONDARY Assessment of Treatment Efficacy by the Participants |
11; 27; 10; 25; 0; 0 | — |
| SECONDARY Assessment of Treatment Handling by the Participants |
13; 37; 8; 15; 1; 0 | — |
| SECONDARY Investigator Assessment of Treatment Satisfaction of Participants |
12; 27; 9; 27; 1; 0 | — |
Summary
The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.
Eligibility Criteria
Inclusion Criteria
- Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.
Exclusion Criteria
- Patients with hemophilia B treated with a product other than BeneFIX®.
- Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.
Data sourced from ClinicalTrials.gov (NCT00714415). 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.