[{"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":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"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":18,"type":19},6,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26],"Diffuse Alveolar Hemorrhage","Antineutrophil Cytoplasmic Antibody Positive Vasculitis","RECRUITING","2026-04-24",{"date":30,"type":31},"2026-04-29","ACTUAL",{"date":33,"type":19},"2026-05",{"date":35,"type":19},"2028-03",{"name":37,"class":38},"Mayo Clinic","OTHER",""]