[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461978":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":18,"locations":32,"responsibleParty":63,"collaborators":18,"id":67,"slug":18,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":18,"overallStatus":35,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"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",[33,51],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Stanford Clinic","RECRUITING","Redwood City","California","94063","United States",{"type":41,"coordinates":42},"Point",[43,44],-122.23635,37.48522,{"lat":44,"lon":43},[47],{"name":28,"role":48,"phone":49,"phoneExt":18,"email":50},"CONTACT","(650) 498-7878","goela21@stanford.edu",{"facility":34,"status":35,"city":52,"state":37,"zip":53,"country":39,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Stanford","94305",{"type":41,"coordinates":55},[56,57],-122.16608,37.42411,{"lat":57,"lon":56},[60],{"name":31,"role":48,"phone":61,"phoneExt":18,"email":62},"(650) 721-2250","alrabadi@stanford.edu",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Aparna Goel","Associate Professor of Medicine","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":78,"type":79},24,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85],"Primary Sclerosing Cholangitis","2025-06-11",{"date":88,"type":89},"2025-06-13","ACTUAL",{"date":91,"type":89},"2023-05-10",{"date":93,"type":79},"2027-12",{"name":65,"class":6},2]