Pharmacokinetics Of Emulsified Avacopan In ANCA-associated Vasculitis With Severe Diffuse Alveolar Hemorrhage
Mayo Clinic
Summary
The purpose of this study is to determine the 72-hour pharmacokinetics of emulsified avacopan at a dose of 30 mg twice daily given to up to 6 patients with active severe GPA or MPA with diffuse alveolar hemorrhage (DAH) requiring mechanical ventilation for respiratory support.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis MPA). * Positivity for ANCA, directed against PR3 or MPO. * Diffuse alveolar hemorrhage. * Respiratory failure requiring mechanical ventilation. * Severe newly diagnosed disease or severe relapsing disease. Severe new or relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary. * Minimum BVAS-…
Interventions
- DrugAvacopan
Avacopan capsules will be solubilized in heated water and administered to patients with Diffuse Alveolar Hemorrhage (DAH) due to GPA or MPA via nasogatric tube.
Location
- Mayo Clinic in RochesterRochester, Minnesota