FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study (NCT05639543) | Clinical Trial Compass
TerminatedPhase 2
FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
Stopped: Intercept made the business decision to terminate the study on 31 Mar 2026 as there was no clear evidence of potential benefit of INT-787 in sAH. This decision was not based on a safety concern.
United States67 participantsStarted 2022-12-15
Plain-language summary
The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Males or females aged 18 to 65 years (inclusive)
✓. Clinical diagnosis of sAH based on all the following:
✓. History of ongoing excess alcohol (\>60 g/day \[male\] or \>40 g/day \[female\]) use for ≥6 months, with \<60 days of abstinence prior to the onset of jaundice
✓. Serum total bilirubin \>3.0 mg/dL
✓. Aspartate aminotransferase (AST) ≥50 U/L
✓. AST/Aspartate aminotransferase (ALT) ratio ≥1.5
✓. Onset of jaundice within prior 8 weeks
✓. Cohort 1 through Cohort 4: Maddrey's Discriminant Factor (mDF) ≥32 and ≤70
Exclusion criteria
✕. Participants taking products containing obeticholic acid in the 30 days prior to randomization
✕. Participants taking \>2 doses of systemic corticosteroids within 30 days prior to randomization.
✕. Participants who have been inpatient at a referral hospital for \>7 days prior to transfer.
✕. Pregnancy, planned pregnancy, potential for pregnancy (e.g., unwillingness to use effective birth control during the study), or current or planned breast feeding.
✕. Abstinence from alcohol consumption for \>2 months before Day 1.
What they're measuring
1
Lille model response based on Lille score by treatment group