[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461978":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":18,"locations":32,"responsibleParty":64,"collaborators":18,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":18,"overallStatus":35,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hymecromone","EXPERIMENTAL","Participants will receive Hymecromone for six months + Standard Of Care (SOC), and will be followed for an additional nine months.",[13],"Drug: Hymecromone",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Of Care (SOC)","NO_INTERVENTION","Participants will receive Standard Of Care (SOC), and will be followed for 15 months.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Hymecromone 400 mg 3 times daily by mouth.",[9],[25],"Isochol",[27,30],{"name":28,"affiliation":5,"role":29},"Aparna Goel, MD","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":5,"role":29},"Leina Alrabadi, MD",[33,52],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Stanford Clinic","RECRUITING","Redwood City","California","94063","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-122.23635,37.48522,{"lat":45,"lon":44},[48],{"name":28,"role":49,"phone":50,"phoneExt":18,"email":51},"CONTACT","(650) 498-7878","goela21@stanford.edu",{"facility":34,"status":35,"city":53,"state":37,"zip":54,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Stanford","94305",{"type":42,"coordinates":56},[57,58],-122.16608,37.42411,{"lat":58,"lon":57},[61],{"name":31,"role":49,"phone":62,"phoneExt":18,"email":63},"(650) 721-2250","alrabadi@stanford.edu",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Aparna Goel","Associate Professor of Medicine","100461978","phase-2-oral-hymecromone-to-treat-adolescents-and-adults-with-primary-sclerosing-cholangitis-100461978",false,"NCT05295680","Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.","A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).","HAAPS","Inclusion Criteria:\n\n* Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and\u002For imaging study\n* If history of endoscopically confirmed inflammatory bowel disease, currently stable based on Mayo Score \u002F Disease Activity Index (DAI) for Ulcerative Colitis Score ≤ 1, normal inflammatory markers (ESR, CRP and fecal calprotectin) and stable non-excluded medical therapy for at least 6 months\n\nExclusion Criteria:\n\n* Currently receiving biologic therapies\n* Known allergy to hymecromone\n* Cholangiocarcinoma\n* Pregnancy\n* Serious liver disease","ALL","14 Years","75 Years",{"count":80,"type":81},24,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","Primary objective: To evaluate the efficacy of hymecromone plus standard of care compared with standard of care alone in the treatment of adolescents and adults with primary sclerosing cholangitis (PSC).\n\nSecondary objectives: To evaluate the change in Alkaline Phosphatase (ALP) from baseline to 6 months post-treatment following treatment with hymecromone plus standard of care compared with standard of care.\n\nTo evaluate changes in biomarkers of PSC disease during hymecromone treatment, namely: (a) fibrotic effect (FibroScan); (b) inflammatory biomarkers (serum Hyaluronan (HA)); and, (c) T-cell count.",[87],"Primary Sclerosing Cholangitis","2025-06-11",{"date":90,"type":91},"2025-06-13","ACTUAL",{"date":93,"type":91},"2023-05-10",{"date":95,"type":81},"2027-12",{"name":66,"class":6},2]