[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aparna Goel\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Primary Sclerosing Cholangitis","RECRUITING","2025-06-11",{"date":32,"type":33},"2025-06-13","ACTUAL",{"date":35,"type":33},"2023-05-10",{"date":37,"type":22},"2027-12",{"name":39,"class":40},"Aparna Goel","OTHER",2,""]