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| Name | Class |
|---|---|
| CTI Clinical Trial and Consulting Services | OTHER |
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This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DUR-928 (larsucosterol, 30 mg) | Experimental |
| |
| DUR-928 (larsucosterol, 90 mg) | Experimental |
| |
| (Placebo) Sterile Water for Injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DUR-928 30 mg | Drug | IV infusion |
| |
| DUR-928 90 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo. | Day 90 | |
| Difference in 28-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo. | Day 28 |
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Inclusion Criteria:
Able to provide written informed consent (either from subject or subject's legally acceptable representative).
Onset of jaundice within prior 8 weeks.
Average daily consumption of >40 (females) or >60 (males) grams of alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice.
The determination of AH may be based on typical serum chemistry (as determined by local laboratory) or liver biopsy at any time during the current episode of AH:
Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.
Model for End-stage Liver Disease (MELD) score: 21-30.
Liver biopsy is not required, but may be used to confirm the diagnosis of AH at the Investigator's discretion. Biopsy, if used as a diagnostic criterion, must have occurred during the current episode.
Male or female subjects 18 years of age or older.
Subjects must agree to use effective methods to prevent pregnancy while participating in the study.
Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Gordon, MD, FACS | CTI Clinical Trial and Consulting Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hospital | Birmingham | Alabama | 35233 | United States | ||
| Mayo Clinic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39873544 | Derived | Shiffman M, Da B, Goel A, Kwong A, Stein L, Moreno C, Nicoll A, Mehta A, Louvet A, Flamm S, Pyrsopoulos N, Satapathy S, Kuo A, Ganger D, Aloman C, Strasser SI, Tse E, Russo MW, Rockey D, Gray M, Mitchell M, Thursz M, Krebs W, Scott D, Blevins C, Ellis D, Brown J, Sussman N, Lin W. Larsucosterol for the Treatment of Alcohol-Associated Hepatitis. NEJM Evid. 2025 Feb;4(2):EVIDoa2400243. doi: 10.1056/EVIDoa2400243. Epub 2025 Jan 28. |
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This is a Phase 2b randomized, double-blind, placebo-controlled, multi-arm, multi-center, parallel design trial.
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| Drug |
IV infusion |
|
| Placebo+ Standard of Care (SOC) | Drug | IV infusion |
|
| Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo. | Day 28 |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Southern California Research Center | Coronado | California | 92118 | United States |
| Keck Hospital of University of Southern California (USC) | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California Davis (UC Davis) Medical Center | Sacramento | California | 95817 | United States |
| University of California San Francisco (UCSF) Medical Center | San Francisco | California | 94143 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| MedStar Health - MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Richard Roudebush VA Hospital | Indianapolis | Indiana | 46202 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| University of Minnesota Medical School | Minneapolis | Minnesota | 55455 | United States |
| Saint Luke's Health System - Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center (UNMC) | Omaha | Nebraska | 68198 | United States |
| Rutgers-New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| University of New Mexico (UNM) Hospital | Albuquerque | New Mexico | 87106 | United States |
| Northwell Health - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| New York-Presbyterian - Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Medical University of South Carolina (MUSC) Health - University Medical Center | Charleston | South Carolina | 29425 | United States |
| Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| Baylor Scott and White Health | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern (Clements University Hospital) | Dallas | Texas | 75390 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Doctors Hospital at Renaissance (DHR) | Edinburg | Texas | 78539 | United States |
| Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Utah Health - The University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| University of Virginia (UVA) Health - University Hospital | Charlottesville | Virginia | 22908 | United States |
| Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| Harborview Medical Center - University of Washington | Seattle | Washington | 98104 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Nepean Hospital | Kingswood | New South Wales | 2217 | Australia |
| Mater Health - Mater Hospital Brisbane | South Brisbane | Queensland | 4101 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Eastern Health - Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Landeskrankenhaus (LKH) - Universitätsklinikum Graz | Graz | 8036 | Austria |
| Université libre de Bruxelles (ULB) - Hôpital Erasme | Brussels | 1070 | Belgium |
| Universitair Ziekenhuis Antwerpen (UZA) | Edegem | 2650 | Belgium |
| Centre Hospitalier Régional Universitaire (CHRU) Besançon - Hôpital Jean Minjoz | Besançon | 25000 | France |
| Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Jeanne de Flandre | Lille | 59037 | France |
| Hospices Civils de Lyon - Hôpital de la Croix-Rousse | Lyon | 69004 | France |
| Hôpital St Joseph | Marseille | 13008 | France |
| Barts Health NHS Trust - The Royal London Hospital | London | England | E1 1FR | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | England | SE5 9RS | United Kingdom |
| Imperial College Healthcare NHS Trust - St. Mary's Hospital | London | England | W2 1NY | United Kingdom |
| University Hospitals Plymouth NHS Trust - Derriford Hospital | Plymouth | England | PL6 8DH | United Kingdom |
| Royal Free London NHS Foundation Trust Hospital | London | NW3 2QG | United Kingdom |
| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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