[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625892":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":479,"collaborators":481,"id":484,"slug":485,"hasResults":486,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":32,"eligibilityCriteria":490,"healthyVolunteers":486,"sex":491,"minAge":492,"maxAge":32,"enrollmentInfo":493,"targetDuration":32,"studyType":496,"phases":497,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":211,"whyStopped":32,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":516},{"fullName":5,"class":6},"Bausch Health Americas, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Larsucosterol 30 mg","EXPERIMENTAL","Participants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.",[13],"Drug: Larsucosterol",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.",[19],"Drug: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Larsucosterol","Larsucosterol intravenous infusion.",[9],[27,28],"DUR928","DV928",{"type":22,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"Matching-placebo (sterile water for injection) intravenous infusion.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Jimin Lee, Ph.D","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Varsha Bhatt","CONTACT","707-230-1712","varsha.bhatt@bauschhealth.com",{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},"Natalie Pastelak","445-242-7581","natalie.pastelak@bauschhealth.com",[48,62,72,78,88,97,103,112,121,130,140,150,159,169,179,189,199,209,220,226,236,242,248,257,267,276,286,296,306,316,324,334,344,353,363,372,378,384,390,400,410,416,425,435,444,454,463,469],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":32},"University of Alabama at Birmingham (UAB) Hospital","NOT_YET_RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-86.80249,33.52066,{"lat":60,"lon":59},{"facility":63,"status":50,"city":64,"state":65,"zip":66,"country":54,"countryCode":55,"cosmosGeoPoint":67,"geoPoint":71,"contacts":32},"Banner - University Medical Center, Phoenix, Arizona","Phoenix","Arizona","85006",{"type":57,"coordinates":68},[69,70],-112.07404,33.44838,{"lat":70,"lon":69},{"facility":73,"status":50,"city":64,"state":65,"zip":74,"country":54,"countryCode":55,"cosmosGeoPoint":75,"geoPoint":77,"contacts":32},"Mayo Clinic - Phoenix","85054",{"type":57,"coordinates":76},[69,70],{"lat":70,"lon":69},{"facility":79,"status":50,"city":80,"state":81,"zip":82,"country":54,"countryCode":55,"cosmosGeoPoint":83,"geoPoint":87,"contacts":32},"Southern California GI & Liver Centers - Coronado","Coronado","California","92118",{"type":57,"coordinates":84},[85,86],-117.18309,32.68589,{"lat":86,"lon":85},{"facility":89,"status":50,"city":90,"state":81,"zip":91,"country":54,"countryCode":55,"cosmosGeoPoint":92,"geoPoint":96,"contacts":32},"Cedars Sinai Medical Center","Los Angeles","90048",{"type":57,"coordinates":93},[94,95],-118.24368,34.05223,{"lat":95,"lon":94},{"facility":98,"status":50,"city":90,"state":81,"zip":99,"country":54,"countryCode":55,"cosmosGeoPoint":100,"geoPoint":102,"contacts":32},"UCLA Health - Ronald Reagan Medical Center","90095",{"type":57,"coordinates":101},[94,95],{"lat":95,"lon":94},{"facility":104,"status":50,"city":105,"state":81,"zip":106,"country":54,"countryCode":55,"cosmosGeoPoint":107,"geoPoint":111,"contacts":32},"Stanford Medicine - Clinical and Translational Research Unit - Redwood City","Redwood City","94063",{"type":57,"coordinates":108},[109,110],-122.23635,37.48522,{"lat":110,"lon":109},{"facility":113,"status":50,"city":114,"state":81,"zip":115,"country":54,"countryCode":55,"cosmosGeoPoint":116,"geoPoint":120,"contacts":32},"University of California at Davis Medical Center","Sacramento","95757",{"type":57,"coordinates":117},[118,119],-121.4944,38.58157,{"lat":119,"lon":118},{"facility":122,"status":50,"city":123,"state":81,"zip":124,"country":54,"countryCode":55,"cosmosGeoPoint":125,"geoPoint":129,"contacts":32},"Sutter Health","San Francisco","94109",{"type":57,"coordinates":126},[127,128],-122.41942,37.77493,{"lat":128,"lon":127},{"facility":131,"status":50,"city":132,"state":133,"zip":134,"country":54,"countryCode":55,"cosmosGeoPoint":135,"geoPoint":139,"contacts":32},"Georgetown University Medical Center","Washington D.C.","District of Columbia","20007",{"type":57,"coordinates":136},[137,138],-77.03637,38.89511,{"lat":138,"lon":137},{"facility":141,"status":50,"city":142,"state":143,"zip":144,"country":54,"countryCode":55,"cosmosGeoPoint":145,"geoPoint":149,"contacts":32},"AdventHealth Transplant Institute","Orlando","Florida","32804",{"type":57,"coordinates":146},[147,148],-81.37924,28.53834,{"lat":148,"lon":147},{"facility":151,"status":50,"city":152,"state":143,"zip":153,"country":54,"countryCode":55,"cosmosGeoPoint":154,"geoPoint":158,"contacts":32},"Tampa General Hospital","Tampa","33606",{"type":57,"coordinates":155},[156,157],-82.45843,27.94752,{"lat":157,"lon":156},{"facility":160,"status":50,"city":161,"state":162,"zip":163,"country":54,"countryCode":55,"cosmosGeoPoint":164,"geoPoint":168,"contacts":32},"Piedmont Atlanta Hospital - Piedmont Transplant Institute","Atlanta","Georgia","30309",{"type":57,"coordinates":165},[166,167],-84.38798,33.749,{"lat":167,"lon":166},{"facility":170,"status":50,"city":171,"state":172,"zip":173,"country":54,"countryCode":55,"cosmosGeoPoint":174,"geoPoint":178,"contacts":32},"Rush University Medical Center","Chicago","Illinois","60612",{"type":57,"coordinates":175},[176,177],-87.65005,41.85003,{"lat":177,"lon":176},{"facility":180,"status":50,"city":181,"state":182,"zip":183,"country":54,"countryCode":55,"cosmosGeoPoint":184,"geoPoint":188,"contacts":32},"University of Iowa Hospitals & Clinics","Iowa City","Iowa","52242",{"type":57,"coordinates":185},[186,187],-91.53017,41.66113,{"lat":187,"lon":186},{"facility":190,"status":50,"city":191,"state":192,"zip":193,"country":54,"countryCode":55,"cosmosGeoPoint":194,"geoPoint":198,"contacts":32},"Robley Rex VA Medical Center","Louisville","Kentucky","40206",{"type":57,"coordinates":195},[196,197],-85.75941,38.25424,{"lat":197,"lon":196},{"facility":200,"status":50,"city":201,"state":202,"zip":203,"country":54,"countryCode":55,"cosmosGeoPoint":204,"geoPoint":208,"contacts":32},"Tulane University Health Sciences Center - Tulane Avenue","New Orleans","Louisiana","70112",{"type":57,"coordinates":205},[206,207],-90.07507,29.95465,{"lat":207,"lon":206},{"facility":210,"status":211,"city":212,"state":213,"zip":214,"country":54,"countryCode":55,"cosmosGeoPoint":215,"geoPoint":219,"contacts":32},"Mercy Medical Center - The Institute for Digestive Health and Liver Disease","RECRUITING","Baltimore","Maryland","21202",{"type":57,"coordinates":216},[217,218],-76.61219,39.29038,{"lat":218,"lon":217},{"facility":221,"status":50,"city":212,"state":213,"zip":222,"country":54,"countryCode":55,"cosmosGeoPoint":223,"geoPoint":225,"contacts":32},"Johns Hopkins Hospital","21287",{"type":57,"coordinates":224},[217,218],{"lat":218,"lon":217},{"facility":227,"status":50,"city":228,"state":229,"zip":230,"country":54,"countryCode":55,"cosmosGeoPoint":231,"geoPoint":235,"contacts":32},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":57,"coordinates":232},[233,234],-71.05977,42.35843,{"lat":234,"lon":233},{"facility":237,"status":50,"city":228,"state":229,"zip":238,"country":54,"countryCode":55,"cosmosGeoPoint":239,"geoPoint":241,"contacts":32},"Boston University School of Medicine","02118",{"type":57,"coordinates":240},[233,234],{"lat":234,"lon":233},{"facility":243,"status":50,"city":228,"state":229,"zip":244,"country":54,"countryCode":55,"cosmosGeoPoint":245,"geoPoint":247,"contacts":32},"Beth Israel Deaconess Medical Center","02215",{"type":57,"coordinates":246},[233,234],{"lat":234,"lon":233},{"facility":249,"status":50,"city":250,"state":229,"zip":251,"country":54,"countryCode":55,"cosmosGeoPoint":252,"geoPoint":256,"contacts":32},"UMass Chan Medical School","Worcester","01655",{"type":57,"coordinates":253},[254,255],-71.80229,42.26259,{"lat":255,"lon":254},{"facility":258,"status":50,"city":259,"state":260,"zip":261,"country":54,"countryCode":55,"cosmosGeoPoint":262,"geoPoint":266,"contacts":32},"University of Michigan","Ann Arbor","Michigan","48109",{"type":57,"coordinates":263},[264,265],-83.74088,42.27756,{"lat":265,"lon":264},{"facility":268,"status":50,"city":269,"state":260,"zip":270,"country":54,"countryCode":55,"cosmosGeoPoint":271,"geoPoint":275,"contacts":32},"Henry Ford Hospital System","Detroit","48202",{"type":57,"coordinates":272},[273,274],-83.04575,42.33143,{"lat":274,"lon":273},{"facility":277,"status":50,"city":278,"state":279,"zip":280,"country":54,"countryCode":55,"cosmosGeoPoint":281,"geoPoint":285,"contacts":32},"University of Minnesota Medical Center","Minneapolis","Minnesota","55414-2924",{"type":57,"coordinates":282},[283,284],-93.26384,44.97997,{"lat":284,"lon":283},{"facility":287,"status":50,"city":288,"state":289,"zip":290,"country":54,"countryCode":55,"cosmosGeoPoint":291,"geoPoint":295,"contacts":32},"Rutgers University New Jersey Medical School","Newark","New Jersey","07103-2425",{"type":57,"coordinates":292},[293,294],-74.17237,40.73566,{"lat":294,"lon":293},{"facility":297,"status":50,"city":298,"state":299,"zip":300,"country":54,"countryCode":55,"cosmosGeoPoint":301,"geoPoint":305,"contacts":32},"University of New Mexico (UNM) Hospital","Albuquerque","New Mexico","87106-4713",{"type":57,"coordinates":302},[303,304],-106.65114,35.08449,{"lat":304,"lon":303},{"facility":307,"status":50,"city":308,"state":309,"zip":310,"country":54,"countryCode":55,"cosmosGeoPoint":311,"geoPoint":315,"contacts":32},"Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases","Manhasset","New York","11030",{"type":57,"coordinates":312},[313,314],-73.69957,40.79788,{"lat":314,"lon":313},{"facility":317,"status":50,"city":309,"state":309,"zip":318,"country":54,"countryCode":55,"cosmosGeoPoint":319,"geoPoint":323,"contacts":32},"NYU Langone Health","10016",{"type":57,"coordinates":320},[321,322],-74.00597,40.71427,{"lat":322,"lon":321},{"facility":325,"status":50,"city":326,"state":327,"zip":328,"country":54,"countryCode":55,"cosmosGeoPoint":329,"geoPoint":333,"contacts":32},"Levine Cancer Institute \u002F Atrium Health","Charlotte","North Carolina","28204",{"type":57,"coordinates":330},[331,332],-80.84313,35.22709,{"lat":332,"lon":331},{"facility":335,"status":50,"city":336,"state":337,"zip":338,"country":54,"countryCode":55,"cosmosGeoPoint":339,"geoPoint":343,"contacts":32},"University Hospitals Cleveland Medical Center","Cleveland","Ohio","44106",{"type":57,"coordinates":340},[341,342],-81.69541,41.4995,{"lat":342,"lon":341},{"facility":345,"status":50,"city":346,"state":337,"zip":347,"country":54,"countryCode":55,"cosmosGeoPoint":348,"geoPoint":352,"contacts":32},"The Ohio State University Wexner Medical Center (OSUWMC)","Columbus","43210",{"type":57,"coordinates":349},[350,351],-82.99879,39.96118,{"lat":351,"lon":350},{"facility":354,"status":50,"city":355,"state":356,"zip":357,"country":54,"countryCode":55,"cosmosGeoPoint":358,"geoPoint":362,"contacts":32},"Penn State Health, Milton S. Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":57,"coordinates":359},[360,361],-76.65025,40.28592,{"lat":361,"lon":360},{"facility":364,"status":50,"city":365,"state":356,"zip":366,"country":54,"countryCode":55,"cosmosGeoPoint":367,"geoPoint":371,"contacts":32},"VA Medical Center - Philadelphia","Philadelphia","19104-4551",{"type":57,"coordinates":368},[369,370],-75.16362,39.95238,{"lat":370,"lon":369},{"facility":373,"status":50,"city":365,"state":356,"zip":374,"country":54,"countryCode":55,"cosmosGeoPoint":375,"geoPoint":377,"contacts":32},"University of Pennsylvania Hospital","19104",{"type":57,"coordinates":376},[369,370],{"lat":370,"lon":369},{"facility":379,"status":50,"city":365,"state":356,"zip":380,"country":54,"countryCode":55,"cosmosGeoPoint":381,"geoPoint":383,"contacts":32},"Thomas Jefferson University Hospital","19107",{"type":57,"coordinates":382},[369,370],{"lat":370,"lon":369},{"facility":385,"status":50,"city":365,"state":356,"zip":386,"country":54,"countryCode":55,"cosmosGeoPoint":387,"geoPoint":389,"contacts":32},"Temple University Hospital","19140",{"type":57,"coordinates":388},[369,370],{"lat":370,"lon":369},{"facility":391,"status":211,"city":392,"state":393,"zip":394,"country":54,"countryCode":55,"cosmosGeoPoint":395,"geoPoint":399,"contacts":32},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":57,"coordinates":396},[397,398],-79.93275,32.77632,{"lat":398,"lon":397},{"facility":401,"status":211,"city":402,"state":403,"zip":404,"country":54,"countryCode":55,"cosmosGeoPoint":405,"geoPoint":409,"contacts":32},"The Liver Institute at Methodist Dallas Medical Center","Dallas","Texas","75203",{"type":57,"coordinates":406},[407,408],-96.80667,32.78306,{"lat":408,"lon":407},{"facility":411,"status":50,"city":402,"state":403,"zip":412,"country":54,"countryCode":55,"cosmosGeoPoint":413,"geoPoint":415,"contacts":32},"Baylor Scott White Research Institute - Dallas","75246",{"type":57,"coordinates":414},[407,408],{"lat":408,"lon":407},{"facility":417,"status":211,"city":418,"state":403,"zip":419,"country":54,"countryCode":55,"cosmosGeoPoint":420,"geoPoint":424,"contacts":32},"Baylor College of Medicine (BCM) - Baylor Clinic","Houston","77030",{"type":57,"coordinates":421},[422,423],-95.36327,29.76328,{"lat":423,"lon":422},{"facility":426,"status":50,"city":427,"state":428,"zip":429,"country":54,"countryCode":55,"cosmosGeoPoint":430,"geoPoint":434,"contacts":32},"Intermountain Transplant Clinic","Murray","Utah","84107",{"type":57,"coordinates":431},[432,433],-111.88799,40.66689,{"lat":433,"lon":432},{"facility":436,"status":50,"city":437,"state":428,"zip":438,"country":54,"countryCode":55,"cosmosGeoPoint":439,"geoPoint":443,"contacts":32},"University of Utah Health - University of Utah","Salt Lake City","84132",{"type":57,"coordinates":440},[441,442],-111.89105,40.76078,{"lat":442,"lon":441},{"facility":445,"status":50,"city":446,"state":447,"zip":448,"country":54,"countryCode":55,"cosmosGeoPoint":449,"geoPoint":453,"contacts":32},"University of Virginia Health","Charlottesville","Virginia","22908",{"type":57,"coordinates":450},[451,452],-78.47668,38.02931,{"lat":452,"lon":451},{"facility":455,"status":50,"city":456,"state":447,"zip":457,"country":54,"countryCode":55,"cosmosGeoPoint":458,"geoPoint":462,"contacts":32},"Bon Secours Liver Institute of Richmond","Richmond","23226",{"type":57,"coordinates":459},[460,461],-77.46026,37.55376,{"lat":461,"lon":460},{"facility":464,"status":211,"city":456,"state":447,"zip":465,"country":54,"countryCode":55,"cosmosGeoPoint":466,"geoPoint":468,"contacts":32},"Richmond VA Medical Center","23249",{"type":57,"coordinates":467},[460,461],{"lat":461,"lon":460},{"facility":470,"status":50,"city":471,"state":472,"zip":473,"country":54,"countryCode":55,"cosmosGeoPoint":474,"geoPoint":478,"contacts":32},"Marshall Health","Huntington","West Virginia","25701",{"type":57,"coordinates":475},[476,477],-82.44515,38.41925,{"lat":477,"lon":476},{"type":480,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[482],{"name":483,"class":6},"Durect","100625892","phase-3-study-to-evaluate-the-safety-and-efficacy-of-larsucosterol-in-participants-with-alcohol-associated-hepatitis-ah-100625892",false,"NCT07428538","Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)","RE-AHFIRM (RandomizEd Study of Larsucosterol in Alcohol-associated Hepatitis to Confirm saFety and effIcacy of tReatMent)","Inclusion Criteria-\n\nA participant will be eligible for inclusion in this study if he\u002Fshe meets all the following criteria:\n\n1. Able to provide written informed consent (either from participant or participant's legally acceptable representative).\n2. Onset of jaundice within 8 weeks before hospital admission.\n3. Average daily consumption of greater than (\\>) 40 (females) or \\>60 (males) grams alcohol for 6 months or longer, with less than (\\\u003C) 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made and documented by the site Investigator.\n4. The determination of AH will be based on typical serum chemistry (as determined by local laboratory):\n\n   1. Serum total bilirubin \\>3.0 milligrams per deciliter (mg\u002FdL) (required at randomization)\n   2. ALT \\\u003C400 international unit per Liter (IU\u002FL) (required at randomization)\n   3. 50 \\\u003CAST \\\u003C400 IU\u002FL\n   4. AST \\\u003C400 IU\u002FL (required at randomization)\n   5. AST \\>50 IU\u002FL (at any time since current hospital admission or leading to this current hospitalization)\n   6. AST\u002FALT \\>1.5 (at any time since current hospital admission or leading to this current hospitalization)\n5. Maddrey discriminant function (MDF) \\>=32, assuming a control prothrombin time of 12 seconds.\n\n   NOTE: If a local laboratory's control time differs from 12 seconds, then the local laboratory's control time should be used. If control time is not stated or is stated as a range, the control time should be calculated by the formula prothrombin time\u002FINR.\n6. Original Model for End-stage Liver Disease (MELD; not MELD-Na) score: 21-30 (inclusive).\n7. Male or female participants 18 years of age or older.\n8. Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the 90-day portion of the study. Acceptable methods that may be used are abstinence, birth control pills (\"The Pill\") or patch, diaphragm, IUD (coil), vaginal ring, condom, surgical sterilization or progestin implant or injection, or sexual activity limited to a sterile (e.g., vasectomized) male partner.\n9. Male participants must agree to use a medically acceptable method of contraception\u002Fbirth control and refrain from sperm donation throughout the 90-day portion of the study.\n10. Participants must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.\n11. Participants must be dosed within 9 calendar days (216 hours) of hospital admission inclusive of time spent in other hospital(s)\n\nExclusion Criteria-\n\nA participant will be excluded from the study if he or she meets any of the following criteria:\n\n1. Participants using systemic corticosteroids for current AH before enrollment or having a history of using systemic corticosteroids for more than 8 days in the last 30 days prior to screening.\n\n   NOTE: Inhaled, topical, or local corticosteroid injections are permitted NOTE: A participant who has a confirmed diagnosis of hypoadrenalism and is taking a physiological replacement dose of hydrocortisone (or equivalent) is permitted to take part in the trial\n2. Participants experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.\n3. Active infection (such as spontaneous bacterial peritonitis \\[SBP\\], urinary tract infection \\[UTI\\], cellulitis, pneumonia, bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).\n\n   1. Participants who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.\n   2. Participants with bacterial infections may be enrolled provided they remain in the enrollment window and the infection is adequately treated. For example, participants with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP.\n   3. Participants with systemic fungal infection of any kind cannot be considered for this trial.\n4. Serum creatinine \\>2.5 mg\u002FdL.\n5. Participants undergoing continuous veno-venous hemodialysis (CVVH).\n6. Gastrointestinal bleeding not controlled by local therapy (i.e., band ligation or injection sclerotherapy). Participant who are at high risk of rebleeding or likely in need of TIPS insertion should be excluded.\n7. TIPS insertion or variceal embolization within the last 4 weeks.\n8. Known portal vein occlusion.\n9. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.\n10. Liver biopsy (if carried out) with findings not compatible with AH. NOTE: A post-dose liver biopsy that is not compatible with AH will not be considered a protocol deviation.\n11. Stage \\>=3 hepatic encephalopathy by West Haven criteria.\n12. Participants with medical conditions that are expected to pose a high risk of short-term (less than or equal to \\[\\\u003C=\\] 90 days) mortality unrelated to alcohol-associated hepatitis, or that may confound assessment of 90-day survival in the Investigator's judgement. Examples include, but are not limited to:\n\n    1. Severe concomitant cardiopulmonary disease (e.g., New York Heart Association \\[NYHA\\] Class III or IV heart failure)\n    2. Clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia, unmanaged atrial fibrillation, QTc \\>=500 msec, or high-grade AV block)\n    3. Ventilator-dependent respiratory failure, or Global Initiative for Chronic Obstructive Lung Disease \\[GOLD\\] Stage III or IV chronic obstructive pulmonary disease \\[COPD\\])\n    4. End-stage renal disease requiring chronic, ongoing dialysis\n    5. Severe uncontrolled endocrine or metabolic disorders\n    6. Severe psychiatric illness likely to interfere with study participation\n    7. Hypotension\u002Fshock as defined by the North American Consortium for the study of End-stage Liver Disease (NACSELD) criteria (i.e., Mean Arterial Pressure \\[MAP\\] \\\u003C60 millimeter of mercury (mmHg), despite adequate fluid resuscitation and cardiac output)\n13. Other concomitant cause(s) of liver disease as a result of:\n\n    1. Autoimmune liver disease\n    2. Ischemic hepatitis\n    3. Wilson disease or alpha 1 antitrypsin deficiency\n    4. Vascular liver disease (e.g., Budd-Chiari)\n    5. Drug induced liver disease\n    6. Surface antigen positive hepatitis B (HBsAg+). NOTE: Participants with isolated core antibody (anti-HBc) or who are on stable antiviral medication with known viral suppression are not excluded, but appropriate HBV prophylaxis should be considered if steroid dosing \\>4 weeks is anticipated.\n    7. Acute hepatitis A (if test performed per SOC)\n    8. Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. NOTE: participants with stable chronic HCV or successfully treated HCV are not excluded\n    9. Acute hepatitis E (if test performed per SOC)\n    10. Acute cytomegalovirus (CMV) viral hepatitis (if test performed per SOC)\n14. Any known active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).\n15. Existing or intended pregnancy or breast feeding.\n16. Participation in another interventional clinical trial within 30 days of Screening.\n17. History of organ transplantation other than corneal transplant.\n18. Underlying disease that, in the opinion of the site Investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.\n19. Participant listed for liver transplant (LT) prior to study drug administration.\n20. Concern of participant's willingness and ability to be compliant with the schedule of protocol assessments, per the Investigator's judgement.","ALL","18 Years",{"count":494,"type":495},350,"ESTIMATED","INTERVENTIONAL",[498],"PHASE3","The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (\\>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.",[501],"Hepatitis",[503,504,505,506],"Alcoholic hepatitis","alcohol-associated liver disease (ALD)","Liver transplant (LT)","Alcohol-associated hepatitis (AH)","2026-05-05",{"date":509,"type":510},"2026-05-07","ACTUAL",{"date":512,"type":510},"2026-01-29",{"date":514,"type":495},"2028-02",{"name":5,"class":6},48]