What side effects are associated with this type of intervention?

Common treatments for alcoholic hepatitis include corticosteroids, pentoxifylline, and emerging therapies like INT-787. Corticosteroids can cause side effects such as increased risk of infection, hyperglycemia, and gastrointestinal bleeding. Pentoxifylline may lead to nausea, vomiting, and dizziness. Emerging therapies like INT-787, which are being studied for their anti-inflammatory, anti-fibrotic, or hepatoprotective effects, may have side effects that are still being evaluated, but could potentially include gastrointestinal disturbances and liver enzyme abnormalities.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned in the provided context for the treatment of Alcoholic Hepatitis with anti-inflammatory, anti-fibrotic, or hepatoprotective effects similar to INT-787. Generally, treatments for Alcoholic Hepatitis may include corticosteroids like prednisolone to reduce inflammation and pentoxifylline to decrease fibrosis, although their efficacy varies. Supportive care, including nutritional support and abstinence from alcohol, remains a cornerstone of management.

What other types of research exist?

Promising alternatives to INT-787 for alcoholic hepatitis patients include: 1) Direct-acting antivirals (DAAs) like sofosbuvir-based regimens, which have shown efficacy in improving liver function in HCV-related conditions. 2) Statins, which have emerging evidence supporting their use in chronic liver disease and cirrhosis due to their anti-inflammatory and hepatoprotective effects. 3) Angiotensin II receptor blockers (ARBs), which have been studied for their potential benefits in reducing portal hypertension and liver fibrosis.

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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

Be older than 18 years old

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 Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at day 7, 14, 21, 28

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alcoholic Hepatitis, such as S-adenosyl-L-methionine (SAMe), focus on reducing inflammation, preventing fibrosis, and protecting liver cells. SAMe works by replenishing glutathione levels, which helps detoxify harmful substances in the liver, reducing oxidative stress and inflammation. Anti-inflammatory agents aim to decrease liver inflammation, while anti-fibrotic treatments target the reduction of scar tissue formation by inhibiting stellate cell activation. Hepatoprotective agents help in maintaining liver cell integrity and function. These mechanisms are crucial for Alcoholic Hepatitis patients as they help in slowing disease progression, improving liver function, and potentially delaying the need for more invasive treatments like liver transplantation.

Alcoholic liver disease patients treated with S-adenosyl-L-methionine: an in-depth look at liver morphologic data comparing pre and post treatment liver biopsies.

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

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