[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antineutrophil-cytoplasmic-antibody-positive-vasculitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antineutrophil-cytoplasmic-antibody-positive-vasculitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100635730","phase-1-pharmacokinetics-of-emulsified-avacopan-applied-by-ng-tube-100635730",false,"NCT07556484","Pharmacokinetics Of Emulsified Avacopan Applied By NG Tube","Pharmacokinetics Of Emulsified Avacopan In ANCA-associated Vasculitis With Severe Diffuse Alveolar Hemorrhage","Inclusion Criteria\n\n* Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis MPA).\n* Positivity for ANCA, directed against PR3 or MPO.\n* Diffuse alveolar hemorrhage.\n* Respiratory failure requiring mechanical ventilation.\n* Severe newly diagnosed disease or severe relapsing disease. Severe new or relapsing disease is defined as at least one major BVAS\u002FWG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary.\n* Minimum BVAS-WG of 3.\n* Requirement of standard-of-care remission induction therapy for active severe ANCA-associated vasculitis (GPA or MPA).\n\nExclusion Criteria\n\n* Diagnosis with eosinophilic granulomatosis with polyangiitis (EGPA, formally Churg-Strauss syndrome) as defined by the Chapel Hill consensus conference.\n* Allergies: History of severe allergic reaction to avacopan\n* History of documented anti-glomerular basement membrane disease (anti-GBM disease)\n* Previous administration of avacopan within the last 5 days.\n* Concomitant use of a strong CYP3A4 inhibitor.\n* Aspartate aminotransferase \\[AST\\], alanine amino transferase \\[ALT\\], alkaline phosphatase, or total bilirubin elevation \\>2.5 times the upper limit of normal (unless attributed to vasculitis) on routine liver function testing obtained within 3 days prior to anticipated treatment with avacopan.\n* Evidence of prior active or current Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency (HIV) infection.\n* Active serious infection, including localized infection.\n* Pregnancy and breastfeeding","ALL","18 Years",{"count":19,"type":20},6,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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.",[26,27],"Diffuse Alveolar Hemorrhage","Antineutrophil Cytoplasmic Antibody Positive Vasculitis","RECRUITING","2026-04-24",{"date":31,"type":32},"2026-04-29","ACTUAL",{"date":34,"type":20},"2026-05",{"date":36,"type":20},"2028-03",{"name":38,"class":39},"Mayo Clinic","OTHER"]