A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment
NCT ID: NCT04563026
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
307 participants
INTERVENTIONAL
2021-01-22
2023-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DUR-928 (larsucosterol, 30 mg)
DUR-928 30 mg
IV infusion
DUR-928 (larsucosterol, 90 mg)
DUR-928 90 mg
IV infusion
(Placebo) Sterile Water for Injection
Placebo+ Standard of Care (SOC)
IV infusion
Interventions
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DUR-928 30 mg
IV infusion
DUR-928 90 mg
IV infusion
Placebo+ Standard of Care (SOC)
IV infusion
Eligibility Criteria
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Inclusion Criteria
2. Onset of jaundice within prior 8 weeks.
3. 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.
4. 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:
* Serum total bilirubin \> 3.0 mg/dL
* 50 \< AST \< 400 IU/L
* ALT \< 400 IU/L
* AST/ALT \> 1.5
5. Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.
6. Model for End-stage Liver Disease (MELD) score: 21-30.
7. 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.
8. Male or female subjects 18 years of age or older.
9. Subjects must agree to use effective methods to prevent pregnancy while participating in the study.
10. Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.
Exclusion Criteria
2. Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
3. Active infection (such as spontaneous bacterial peritonitis \[SBP\], urinary tract infection \[UTI\], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
4. Serum creatinine \>2.5 mg/dL.
5. Subjects undergoing continuous veno-venous hemodialysis (CVVH).
6. Uncontrolled gastrointestinal bleeding.
7. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
8. Liver biopsy (if carried out) with findings not compatible with AH.
9. Stage ≥3 hepatic encephalopathy by West Haven criteria.
10. Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure.
11. Other concomitant cause(s) of liver disease.
12. Any active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
13. Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications.
14. Existing or intended pregnancy or breast feeding.
15. Participation in another interventional clinical trial within 30 days of Screening.
16. History of organ transplantation, other than a corneal transplant.
17. Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.
18 Years
ALL
No
Sponsors
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CTI Clinical Trial and Consulting Services
OTHER
Durect
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Gordon, MD, FACS
Role: STUDY_DIRECTOR
CTI Clinical Trial and Consulting Services
Locations
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University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Southern California Research Center
Coronado, California, United States
Keck Hospital of University of Southern California (USC)
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Davis (UC Davis) Medical Center
Sacramento, California, United States
University of California San Francisco (UCSF) Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
MedStar Health - MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Richard Roudebush VA Hospital
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Tulane Medical Center
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Saint Luke's Health System - Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center (UNMC)
Omaha, Nebraska, United States
Rutgers-New Jersey Medical School
Newark, New Jersey, United States
University of New Mexico (UNM) Hospital
Albuquerque, New Mexico, United States
Northwell Health - North Shore University Hospital
Manhasset, New York, United States
Mount Sinai Hospital
New York, New York, United States
New York-Presbyterian - Weill Cornell Medical Center
New York, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Medical University of South Carolina (MUSC) Health - University Medical Center
Charleston, South Carolina, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
Parkland Memorial Hospital
Dallas, Texas, United States
Baylor Scott and White Health
Dallas, Texas, United States
University of Texas Southwestern (Clements University Hospital)
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Doctors Hospital at Renaissance (DHR)
Edinburg, Texas, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Utah Health - The University of Utah Hospital
Salt Lake City, Utah, United States
University of Virginia (UVA) Health - University Hospital
Charlottesville, Virginia, United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Harborview Medical Center - University of Washington
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Mater Health - Mater Hospital Brisbane
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Eastern Health - Box Hill Hospital
Box Hill, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Landeskrankenhaus (LKH) - Universitätsklinikum Graz
Graz, , Austria
Université libre de Bruxelles (ULB) - Hôpital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, , Belgium
Centre Hospitalier Régional Universitaire (CHRU) Besançon - Hôpital Jean Minjoz
Besançon, , France
Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Jeanne de Flandre
Lille, , France
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Lyon, , France
Hôpital St Joseph
Marseille, , France
Barts Health NHS Trust - The Royal London Hospital
London, England, United Kingdom
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
Imperial College Healthcare NHS Trust - St. Mary's Hospital
London, England, United Kingdom
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, England, United Kingdom
Royal Free London NHS Foundation Trust Hospital
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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C928-011
Identifier Type: -
Identifier Source: org_study_id
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