A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment (AHFIRM)
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90-day mortality between active group/s and placebo (SOC) group [ Time Frame: Day 90 ]
Secondary Outcome Measures :
28-day mortality between the treatment groups [ Time Frame: Day 28 ]
Occurrence of adverse events or laboratory abnormalities [ Time Frame: Day 1 to Day 90 ]
Percentage of Participants with Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 Laboratory Abnormalities within 90 days of dosing
Lille score at Day 7 after the initiation of study drug treatment between the treatment groups [ Time Frame: Day 7 ]
MELD score at Day 28 after the initiation of study drug treatment between the treatment groups [ Time Frame: Day 28 ]
ICU days at Day 28 [ Time Frame: Day 1 to Day 28 ]
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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. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made by the site investigator.
Serum chemistry (as determined by local laboratory):
Serum total bilirubin > 3.0 mg/dL
50 < AST < 400 IU/L
ALT < 400 IU/L
AST/ALT > 1.5
Maddrey's discriminant function ≥ 32 assuming a control prothrombin time of 12 seconds
Model for End-stage Liver Disease (MELD) score: 21-30
When the diagnosis of AH remains in question, a liver biopsy (if clinically feasible and that subject has no contra-indications) will be required. Historical biopsy is allowed.
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 corticosteroids for a duration exceeding 7 days in the 30 days prior to screening
Subjects experiencing alcohol withdrawal symptoms or treatment with Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol
Active infection. Subjects who are febrile with leukocytosis are also excluded, even if there is no localizing diagnosis of infection.
Serum creatinine >2.5 mg/dL or eGFR < 60 mL/min/1.73 m2
Subjects with acute kidney injury (AKl) or Hepatorenal syndrome