A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment
- Conditions
- Alcoholic Hepatitis
- Interventions
- Drug: DUR-928 30 mgDrug: Placebo+ Standard of Care (SOC)Drug: DUR-928 90 mg
- Registration Number
- NCT04563026
- Lead Sponsor
- Durect
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 307
-
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:
- Serum total bilirubin > 3.0 mg/dL
- 50 < AST < 400 IU/L
- ALT < 400 IU/L
- AST/ALT > 1.5
-
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.
- Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening.
- Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
- Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
- Serum creatinine >2.5 mg/dL.
- Subjects undergoing continuous veno-venous hemodialysis (CVVH).
- Uncontrolled gastrointestinal bleeding.
- A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
- Liver biopsy (if carried out) with findings not compatible with AH.
- Stage ≥3 hepatic encephalopathy by West Haven criteria.
- Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure.
- Other concomitant cause(s) of liver disease.
- Any active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
- Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications.
- Existing or intended pregnancy or breast feeding.
- Participation in another interventional clinical trial within 30 days of Screening.
- History of organ transplantation, other than a corneal transplant.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DUR-928 (larsucosterol, 30 mg) DUR-928 30 mg - (Placebo) Sterile Water for Injection Placebo+ Standard of Care (SOC) - DUR-928 (larsucosterol, 90 mg) DUR-928 90 mg -
- Primary Outcome Measures
Name Time Method Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo. Day 90
- Secondary Outcome Measures
Name Time Method 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 Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo. Day 28
Trial Locations
- Locations (68)
Stanford University Medical Center
🇺🇸Stanford, California, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
New York-Presbyterian - Weill Cornell Medical Center
🇺🇸New York, New York, United States
Universitair Ziekenhuis Antwerpen (UZA)
🇧🇪Edegem, Belgium
Hôpital St Joseph
🇫🇷Marseille, France
Université libre de Bruxelles (ULB) - Hôpital Erasme
🇧🇪Brussels, Belgium
Bon Secours Liver Institute of Richmond
🇺🇸Richmond, Virginia, United States
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Landeskrankenhaus (LKH) - Universitätsklinikum Graz
🇦🇹Graz, Austria
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Eastern Health - Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Keck Hospital of University of Southern California (USC)
🇺🇸Los Angeles, California, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Minnesota Medical School
🇺🇸Minneapolis, Minnesota, 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
Richard Roudebush VA Hospital
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Rutgers-New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Northwell Health - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Baylor Scott and White Health
🇺🇸Dallas, Texas, United States
Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
Baylor College of Medicine Medical Center
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Harborview Medical Center - University of Washington
🇺🇸Seattle, Washington, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
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
Utah Health - The University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
University of Alabama at Birmingham (UAB) Hospital
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
🇫🇷Lyon, France
Southern California Research Center
🇺🇸Coronado, California, United States
University of California San Francisco (UCSF) Medical Center
🇺🇸San Francisco, California, United States
Medical University of South Carolina (MUSC) Health - University Medical Center
🇺🇸Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Royal Free London NHS Foundation Trust Hospital
🇬🇧London, United Kingdom
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
MedStar Health - MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
University of New Mexico (UNM) Hospital
🇺🇸Albuquerque, New Mexico, United States
Doctors Hospital at Renaissance (DHR)
🇺🇸Edinburg, Texas, United States
Saint Luke's Health System - Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Centre Hospitalier Régional Universitaire (CHRU) Besançon - Hôpital Jean Minjoz
🇫🇷Besançon, France
University of Texas Southwestern (Clements University Hospital)
🇺🇸Dallas, Texas, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
University of Virginia (UVA) Health - University Hospital
🇺🇸Charlottesville, Virginia, United States
Mater Health - Mater Hospital Brisbane
🇦🇺South Brisbane, Queensland, Australia
Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Jeanne de Flandre
🇫🇷Lille, France
University of California Davis (UC Davis) Medical Center
🇺🇸Sacramento, California, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Nebraska Medical Center (UNMC)
🇺🇸Omaha, Nebraska, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States