Hemophilia
Conditions
Brief summary
Annualized treated bleeding rate (ABR) in the fitusiran primary efficacy period and in the SOC period.
Detailed description
Annualized spontaneous bleeding rate (AsBR) in the fitusiran primary efficacy period and in the SOC period., Annualized joint bleeding rate (AjBR) in the fitusiran primary efficacy period and in the SOC period, ABR in the fitusiran treatment period (160 weeks) for fitusiran-naïve participants., ABR in the fitusiran treatment period (60 weeks) for rolled-over participants, Change in physical activity, Change in pain intensity, Change in HRQoL, Incidence, severity, seriousness, and relatedness of adverse events (AEs), Change in total score and domain scores, Target joints resolution
Interventions
DRUGSAR439774
Sponsors
Sanofi-Aventis Recherche & Developpement
Eligibility
Sex/Gender
Male
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized treated bleeding rate (ABR) in the fitusiran primary efficacy period and in the SOC period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized spontaneous bleeding rate (AsBR) in the fitusiran primary efficacy period and in the SOC period., Annualized joint bleeding rate (AjBR) in the fitusiran primary efficacy period and in the SOC period, ABR in the fitusiran treatment period (160 weeks) for fitusiran-naïve participants., ABR in the fitusiran treatment period (60 weeks) for rolled-over participants, Change in physical activity, Change in pain intensity, Change in HRQoL, Incidence, severity, seriousness, and relatedness of adverse events (AEs), Change in total score and domain scores, Target joints resolution | — |
Countries
Belgium, Germany, Hungary, Italy, Poland, Romania, Spain
Outcome results
None listed