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Farnesoid X receptor (FXR) agonist

INT-787 for Alcoholic Hepatitis (FRESH Trial)

Phase 2
Recruiting
Research Sponsored by Intercept Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male participants must agree to specific contraception requirements
Clinical diagnosis of sAH based on specific criteria including history of excess alcohol use, serum total bilirubin, AST levels, onset of jaundice, mDF, and MELD score
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at day 7, 14, 21, 28
Awards & highlights

FRESH Trial Summary

This trial will assess safety, efficacy, and how the body processes a drug for severe alcohol-related hepatitis.

Who is the study for?
Adults aged 18-65 with severe alcohol-associated hepatitis (sAH) can join this trial. They must have a history of heavy drinking, specific blood test results indicating liver inflammation, and agree to contraception or abstinence. Those unable to make decisions due to hepatic encephalopathy need consent from a legal representative.Check my eligibility
What is being tested?
The FRESH study is testing the safety and effectiveness of a drug called INT-787 in different doses for patients with sAH. It will also look at how the body processes the drug. Participants are monitored for their response to treatment and any changes in their condition.See study design
What are the potential side effects?
Potential side effects of INT-787 aren't specified but may include reactions related to liver function, digestive issues, or other unexpected health concerns as it's being studied for its safety profile.

FRESH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to follow the study's contraception guidelines.
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I have been diagnosed with severe alcoholic hepatitis based on my alcohol use history and specific blood tests.
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I am between 18 and 65 years old.

FRESH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at day 7, 14, 21, 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at day 7, 14, 21, 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lille model response based on Lille score by treatment group
Secondary outcome measures
Change from Baseline in total bilirubin
Change from baseline in the Model for End-Stage Liver Disease (MELD) score at 28-days by treatment group
Difference in 28-day, 56-day, and 84-day mortality or liver transplantation between INT-787 and placebo
+5 more

FRESH Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: INT-787Active Control1 Intervention
Participants will be randomized to receive INT-787 (escalating doses through the cohorts)
Group II: PlaceboPlacebo Group2 Interventions
Participants will be randomized to receive matching placebo

Find a Location

Who is running the clinical trial?

Intercept PharmaceuticalsLead Sponsor
27 Previous Clinical Trials
16,800 Total Patients Enrolled

Media Library

INT-787 (Farnesoid X receptor (FXR) agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05639543 — Phase 2
Alcoholic Hepatitis Research Study Groups: INT-787, Placebo
Alcoholic Hepatitis Clinical Trial 2023: INT-787 Highlights & Side Effects. Trial Name: NCT05639543 — Phase 2
INT-787 (Farnesoid X receptor (FXR) agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639543 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have any age restrictions, particularly for individuals younger than 60?

"The participants must fulfill the age criteria of being between 18 and 65. Additionally, there are 23 trials available for those under 18 while 198 studies exist that cater to people who surpass 65 years old."

Answered by AI

Is enrollment still open for this research endeavor?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial began enrolling patients as of December 15th 2022 and has been actively recruiting since then; the most recent edit was made on January 5th 2023. 50 participants are expected to be recruited from one site."

Answered by AI

To what extent could INT-787 be detrimental to people's health?

"Our team's assessment of INT-787's safety rating is 2, as the Phase 2 clinical trial has generated evidence of a secure profile but not one that indicates efficacy."

Answered by AI

What is the scale of participants included in this experiment?

"Affirmative. The clinical trial is currently accepting new participants, as evidenced by the information on clinicaltrials.gov. This research was first posted to the website on December 15th 2022 and has been updated recently, January 5th 2023 being the most recent instance. They are looking for 50 individuals from a single site to join them in their endeavour."

Answered by AI

Do I fulfill the prerequisites to take part in this investigation?

"For this trial, 50 people suffering from severe alcohol-induced hepatitis (SAH) between the ages of 18 and 65 are being recruited. To qualify for enrolment, individuals must meet a stringent set of criteria including: male or female gender, excessive consumption in terms of quantity and duration, specific bilirubin levels, AST/ALT ratio values, Maddrey's Discriminant Factor range as well as MELD-Na score falling within an exact window. Furthermore, jaundice onset must have occurred no more than 8 weeks prior to hospital admission with less than 7 days passing since then; patients should also be surgically sterilized"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
2022. "FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639543.
~17 spots leftby Dec 2024
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