A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcoholic Hepatitis

In brief

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).

Key facts

Study ID

NCT04563026

Run by

Durect

People needed

307

Starts

2021-01-22

Expected to finish

2023-09-06

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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