[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440682":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":32,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":32,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":32,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":32,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HA35 Placebo Group","PLACEBO_COMPARATOR","24 study participants will receive the standard of care treatment for AH and a 90-day supply of a placebo to take once a day with breakfast.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"HA35 Treatment Group","ACTIVE_COMPARATOR","24 study participants will receive the standard of care treatment for AH and a 90-day supply of a HA35 to take once a day with breakfast.",[19],"Drug: Sodium Hyaluronate",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sodium Hyaluronate","Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants",[15],[27],"HA35",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","A placebo will be given in capsule form to study participants",[9],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Srinivasan Dasarathy, MD","CONTACT","216-318-7010","dasaras@ccf.org",{"name":40,"role":36,"phone":32,"phoneExt":32,"email":41},"Annette Bellar","bellara@ccf.org",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-81.69541,41.4995,{"lat":55,"lon":54},[58],{"name":40,"role":36,"phone":32,"phoneExt":32,"email":32},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Srinivasan Dasarathy","Staff Physician","100440682","early-phase-1-ha35-moderate-alcoholic-hepatitis-ah-study-100440682",false,"NCT05018481","HA35 Moderate Alcoholic Hepatitis (AH) Study","Mechanism of HA35 in Patients With Alcoholic Liver Disease","Inclusion Criteria:\n\n• Clinical diagnosis of alcoholic hepatitis defined as:\n\n* Regular consumption of alcohol with an intake of \\>60 g daily or \\>420 g weekly on average for men and \\>40 g daily or \\>280 g weekly on average for women for 6 months or more\n\nAND\n\n* MELD \\\u003C21\n* Serum total bilirubin \\>3 mg\u002FdL\n* AST \\>50 IU\u002FI; AST:ALT ratio \\>1.5; Both AST and ALT \\\u003C400 IU\u002FI\n\nOR Histologic evidence of AH.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with gastrointestinal bleeding within 2 weeks\n* Active infection (positive blood or ascitic fluid culture)\n* Overt encephalopathy\n* Renal failure and\u002For on dialysis\n* Medications that alter muscle protein metabolism\n* Myopathies\n* Other end-stage organ diseases\n* Malignancy\n* Solid organ or hematopoietic transplantation\n* Active alcohol withdrawal or ongoing participation in a Clinical Institute Withdrawal Assessment (CIWA) protocol\n* History of recent upper gastrointestinal resection within past 6 months\n* Acute or chronic liver disease due to other active causes, in addition to alcoholic liver disease\n* Inability to provide consent\n* Creatinine \\>2mg\u002FdL\n* Platelets \\\u003C60,000k\u002Ful\n* PT\u002FINR \\>1.7\n* Presence of pedal edema\n* Use of anti-platelet\u002Fanticoagulation drugs or medications that interfere with blood clotting","ALL","21 Years","65 Years",{"count":74,"type":75},54,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","Eligible participants will be asked to take a placebo\u002Ftreatment capsule for 90 days and participate in two in-person study visits, one at the start of the 90 days and the second at the completion of study supplement administration. Both visits will include a physical exam, clinical labs, body composition measurements, muscle strength tests, questionnaires, and urine and stool collections. Additionally, a sugar cocktail will be consumed to measure gut permeability and a muscle biopsy will be collected. The day after the visits, you will need to return to drop off the 24-hour urine collection.\n\nTwo phone visits will be performed in between the in-person visits at day 30 and 60 where you will be asked a series of questionnaires as well as asked about study supplement compliance.",[81],"Alcoholic Hepatitis","2025-11-14",{"date":84,"type":85},"2025-11-17","ACTUAL",{"date":87,"type":85},"2022-09-01",{"date":89,"type":75},"2027-10-01",{"name":5,"class":6},1]