[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-alveolar-hemorrhage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-alveolar-hemorrhage":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100370061","transpire-lung-injury-in-a-longitudinal-cohort-of-pediatric-hsct-patients-100370061",false,"NCT04098445","TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients","Inclusion Criteria:\n\n* Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.\n\nExclusion Criteria:\n\n* Subjects over 24 years of age.","ALL","24 Years",{"count":18,"type":19},2000,"ESTIMATED","OBSERVATIONAL","Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited.\n\nThis is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.",[23,24,25,26,27],"Hematopoietic Stem Cell Transplant (HSCT)","Diffuse Alveolar Hemorrhage","Thrombotic Microangiopathies","Interstitial Pneumonitis","Bronchiolitis Obliterans","RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":32},"2021-09-08",{"date":36,"type":19},"2033-09",{"name":38,"class":39},"Children's Hospital Medical Center, Cincinnati","OTHER",9,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100635730","phase-1-pharmacokinetics-of-emulsified-avacopan-applied-by-ng-tube-100635730","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","18 Years",{"count":50,"type":19},6,"INTERVENTIONAL",[53],"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.",[24,56],"Antineutrophil Cytoplasmic Antibody Positive Vasculitis","2026-04-24",{"date":59,"type":32},"2026-04-29",{"date":61,"type":19},"2026-05",{"date":63,"type":19},"2028-03",{"name":65,"class":39},"Mayo Clinic",1]