N/A
Completed N=86
Treatment Patterns And Outcomes In Patients Treated With Benefix Or Refacto/Refacto AF - A Swedish Cohort Study
Source: ClinicalTrials.gov NCT02740413 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Age of Participants at Disease Diagnosis — 5; 7 years
Summary
The overall aim of the study is to describe demographic and clinical characteristics, treatment patterns and outcomes, in the populations of hemophilia patients treated with BeneFIX and ReFacto/ReFacto AF in Sweden
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Age of Participants at Disease Diagnosis |
5; 7 | — |
| PRIMARY Age of Participants at Start of Treatment With Benefix or Refacto |
18; 30 | — |
| PRIMARY Age of Participants at Start of Replacement Treatment |
16; 27 | — |
| PRIMARY Average Prescribed Dose Per Infusion for Factor VIII and Factor IX Concentrates |
1600; 2500 | — |
| PRIMARY Average Prescribed Dose Per Kilogram Bodyweight for Factor VIII and Factor IX Concentrates |
27; 37 | — |
| PRIMARY Percentage of Participants on Prophylactic Treatment |
78; 56 | — |
| PRIMARY Average Prescribed Frequency of Infusions Per Week Dispensed for Haemophilia A or B Participants With Prophylaxis |
3.9; 3.1 | — |
| PRIMARY Average Prescribed Annual Dose of Factor VIII and IX Concentrates for Participants on Prophylaxis |
286000; 367000 | — |
| PRIMARY Average Prescribed Annual Dose of Factor VIII and IX Concentrates Per Kilogram Bodyweight for Participants on Prophylaxis |
4500; 4700 | — |
| PRIMARY Average Annual Registered Consumption of Factor VIII and IX Concentrates |
80000; 73000 | — |
| PRIMARY Number of Participants With Consumption of Factor VIII, Factor IX, Factor rVIIa and/or aPCC Concentrate |
33; 53; 0; 0 | — |
| PRIMARY Percentage of Time on Refacto or Benefix |
0; 19 | — |
| PRIMARY Average Use of Factor Concentrate Per Surgery Event at Hospital for Invasive Procedures |
13447; 24171 | — |
| PRIMARY Average Factor Concentrate Use at Hospital for Invasive Procedures |
2 | — |
| PRIMARY Average Annual Number of Filled Prescriptions of Factor Concentrate |
5; 11; 11; 11 | — |
| PRIMARY Average Annual Number of Dispensed Units of Factor Concentrate |
109000; 219000; 220000; 235000; 68000; 163000 | — |
| PRIMARY Average Number of Units of Benefix or Refacto |
229000; 191000 | — |
| PRIMARY Total Number of Bleeds |
1.1 | — |
| PRIMARY Number of Joint Bleed, Muscle Bleeds and Other Bleed Events in Participants |
68; 179; 32 | — |
| PRIMARY Gilbert Joint Score |
6 | — |
| PRIMARY Haemophilia Joint Health Score |
15 | — |
| PRIMARY Percentage of Participants With Surgeries |
8; 8; 7; 11; 17; 15 | — |
| PRIMARY Average Relative Dose Intensity of Factor Concentrate Dispensed for Haemophilia A or B Participants on Prophylaxis Based on Dispensed Volume of Units |
103; 96; 88; 71 | — |
| PRIMARY Average Cost of Replacement Treatment (Benefix or Refacto/Refacto AF) Related to Bleed Event |
100000 | — |
| SECONDARY Average Annual Cost of Prescribed Factor Concentrate and Dispensed Replacement Treatment |
2085000; 1351000 | — |
| SECONDARY Average Cost of Replacement Treatment Related to Invasive Procedures |
71000 | — |
Eligibility Criteria
Inclusion Criteria
- The study population will consist of all patients diagnosed with hemophilia (D66.9 (hemophilia A) D67.9 (hemophilia B) in International Statistical Classification of Diseases and Related Health Problems (ICD-10) that have been registered in the Malmö Hemophilia Register since 1977 and that have had at least one registered prescription of BeneFIX or ReFacto/ReFacto AF in the MHR since market authorization of the respective product
Exclusion Criteria
- No exclusion criteria in this study
Data sourced from ClinicalTrials.gov (NCT02740413). 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.