Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis

This research trial is testing a new medicine called INT-787 for adults who have severe liver inflammation due to alcohol. It's a 'Phase 2a' study, meaning it's an early step to see if the medicine works and is safe. Some patients will receive the new medicine, while others will get a placebo (a dummy treament), but no one will know which they are on until the end. This is done to fairly compare the new medicine's effects. Researchers are particularly looking at how well patients respond to treatment after 7 days, using a scoring system called the 'Lille score'. The study will also check what happens to the medicine in the body and if it causes any side effects. It's taking place in several hospitals.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Intercept Pharmaceuticals Inc.

Enrolment target

Start

22 May 2024

Severe Alcohol-Associated Hepatitis

What is this study about?

Imagine your liver is very unwell because of alcohol, a condition called severe alcohol-associated hepatitis. This study is trying to find a new way to help. Researchers are testing a new medicine, which we'll call INT-787, to see if it can make a difference. This is a very important step, as finding new and effective treatments for serious liver conditions is crucial.

In this particular study, doctors want to find out a few key things. First, they need to make sure INT-787 is safe and doesn't cause too many problems for people. They also want to see how well patients can handle the medicine – if it causes uncomfortable side effects, for example. Most importantly, they want to understand if INT-787 actually helps people's liver condition improve. They'll compare it to a dummy medicine (a placebo) to be sure any improvements are really due to INT-787 and not just other things.

This study is also looking at how the medicine moves through the body, which helps researchers understand the best way to give it. By carefully studying this, they hope to learn enough to decide if INT-787 could be a valuable new treatment option for people with this serious liver problem in the future.

Key takeaways

This study is for adults with severe liver damage due to alcohol.
It's testing a new medicine called INT-787 to see if it's safe and helps.
Some people will get the new medicine, others a dummy treatment (placebo).
Participation involves regular hospital visits for check-ups and tests.
The main goal is to see if liver health improves within 7 days.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults who have been diagnosed with severe liver inflammation caused by alcohol. To take part, you must be at least 18 years old – there's no upper age limit, as long as you meet the other health requirements.

Both men and women are welcome to participate. The doctors will also check other aspects of your health to make sure the study is right for you and safe for you to join. This helps protect your well-being and ensures the study results are as clear and helpful as possible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with severe liver inflammation caused by alcohol?
Are you willing to potentially receive either the study medicine or a dummy treatment?
Are you able to attend regular hospital visits for check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive either the new study medicine (INT-787) or a placebo (a dummy treatment). You, your doctor, and the study team won't know which one you are getting. This is a common way to test new medicines fairly.

You would have regular visits to the hospital or clinic. During these visits, doctors and nurses will do various assessments. This includes checking your health, taking blood or urine samples, and asking how you feel to see if the medicine is helping or causing any side effects. They'll keep a close eye on your liver condition, especially during the first week. The total duration of your participation, including follow-up, would be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. A possible benefit of this study is that the new medicine, INT-787, might help improve your severe liver condition. However, there's no guarantee, and you might receive the placebo (dummy treatment) which can't make your condition better directly. There's also a risk you could experience side effects from the study medicine, some of which might be unknown. The study team will carefully explain all known risks before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'severe alcohol-associated hepatitis'?

It's a very serious type of liver inflammation caused by heavy alcohol use. Your liver becomes badly damaged.

What does 'placebo-controlled' mean?

It means some people get the new medicine, and others get a dummy pill or treatment that looks the same but contains no active medicine. This helps compare the new medicine's effects fairly.

What is a 'Phase 2a' study?

It's an early stage of testing a new medicine. Researchers are mainly looking at how safe it is, if it's tolerated well, and if there are any early signs that it might be effective.

Will I know if I'm getting the real medicine or the placebo?

No, during the study, neither you nor your doctors will know. This is called 'double-blind' and helps ensure the study results are not influenced by expectations.

What is a 'Lille score'?

It's a way doctors measure how well your liver (and you) are responding to treatment for this liver condition, especially after the first week.