A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment (AHFIRM)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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).