[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635730":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":53,"collaborators":30,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":30,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":30,"enrollmentInfo":64,"targetDuration":30,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":30,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Avacopan","EXPERIMENTAL","Subjects will receive solubilized avacopan at a dose of 30 mg twice daily for 3 consecutive days, applied via NG tube.",[13],"Drug: Avacopan",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","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.",[9],[20],"Tavneos",[22],{"name":23,"affiliation":5,"role":24},"Ulrich Specks, MD","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Josie Baum","CONTACT","507-422-9010",null,"baum.josephine@mayo.edu",{"name":33,"role":28,"phone":30,"phoneExt":30,"email":34},"Michael Stachowitz","stachowitz.michael@mayo.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-92.4699,44.02163,{"lat":48,"lon":47},[51,52],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":23,"role":24,"phone":30,"phoneExt":30,"email":30},{"type":24,"investigatorFullName":23,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Principal Investigator","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":65,"type":66},6,"ESTIMATED","INTERVENTIONAL",[69],"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.",[72,73],"Diffuse Alveolar Hemorrhage","Antineutrophil Cytoplasmic Antibody Positive Vasculitis","2026-04-24",{"date":76,"type":77},"2026-04-29","ACTUAL",{"date":79,"type":66},"2026-05",{"date":81,"type":66},"2028-03",{"name":5,"class":6},1]