INT-787 for Severe Alcoholic Hepatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Severe Alcoholic HepatitisINT-787 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this trial is to assess dose related safety, early efficacy, pharmacokinetics and pharmacodynamics of INT-787 in patients with severe alcohol-associated hepatitis (sAH).

Eligible Conditions
  • Severe Alcoholic Hepatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Day 28, 56, 84

Day 28
Change from baseline in MELD-Na at 28-days by treatment group
Day 28, 56, 84
Difference in 28-day, 56-day, and 84-day mortality or liver transplantation between INT-787 and placebo
Day 7
Difference in Lille score response by treatment group
Week 12
Elimination half-life for INT-787
Maximum Plasma Concentration (Cmax) for INT-787, tauro-INT-787 and glyco-INT-787
Number of participants with serious treatment-emergent adverse events as assessed by MedDRA v25.1 by treatment group
Number of participants with treatment-emergent adverse events as assessed by MedDRA v25.1 by treatment group
Occurrence of infectious complications as defined by the Infections and infestations system organ class (SOC) by treatment group
Total exposure (area under the curve) for INT-787, tauro-INT-787 and glyco-INT-787

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

INT-787
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: INT-787 · Has Placebo Group · Phase 2

Placebo
Drug
PlaceboComparator Group · 1 Intervention: INT-787 · Intervention Types: Drug
INT-787
Drug
ActiveComparator Group · 1 Intervention: INT-787 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 28, 56, 84

Who is running the clinical trial?

Intercept PharmaceuticalsLead Sponsor
25 Previous Clinical Trials
19,037 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of 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.
You have a score of 18 to 25 (inclusive) on the MELD-Na.
You are admitted to the hospital.
You have had a surgical sterilization procedure.