A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children from 6 Years to < 18 Years of Age with Active ANCA-associated Vasculitis (AAV)

ANCA-associated Vasculitis (AAV)

Proportion of subjects achieving disease remission at week 26 based on PVAS., Proportion of subjects with sustained remission at week 52 based on PVAS. Remission: PVAS score of 0 with prednisone-equivalent dose ≤0.2 mg/kg/day (max dosage 10 mg/day) within past 4 weeks. Or PVAS score of 0 for at least 4 weeks, provided the last PVAS is within the prior 8 weeks, irrespective of glucocorticoid dose., Sustained remission: PVAS remission at week 26 & week 52, without relapses between the 2 time points.

Plasma concentrations of avacopan from day 1 through end of study., Treatment-emergent adverse events, Proportion of subjects achieving disease remission at week 26 based on BVAS., Proportion of subjects with sustained disease remission at week 52 based on BVAS., Mean score of taste and acceptability., Number of subjects across the taste score categories.

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