Autoimmune haemolytic anaemia
Conditions
Brief summary
Number of participants with treatment-emergent adverse events (TEAE)
Detailed description
Mean change from baseline in total bilirubin over time, Mean change from baseline in hemoglobin over time, Mean change from baseline in lactate dehydrogenase over time, Mean change from baseline in reticulocyte count over time, Complement System Classical Pathway Levels as Measured by WIESLAB Assay, Complement System Alternative Pathway Levels as Measured by WIESLAB Assay, Mean change in CH50 over time, Total Complement Factor C4 Levels, PK parameter: Cmax, PK Parameter: AUC, Number of participants with anti-SAR445088 antibodies
Interventions
DRUGriliprubart
Sponsors
Bioverativ USA Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in total bilirubin over time, Mean change from baseline in hemoglobin over time, Mean change from baseline in lactate dehydrogenase over time, Mean change from baseline in reticulocyte count over time, Complement System Classical Pathway Levels as Measured by WIESLAB Assay, Complement System Alternative Pathway Levels as Measured by WIESLAB Assay, Mean change in CH50 over time, Total Complement Factor C4 Levels, PK parameter: Cmax, PK Parameter: AUC, Number of participants with anti-SAR445088 antibodies | — |
Countries
Germany, Italy, Netherlands
Outcome results
None listed