Active not recruitingPHASE3INTERVENTIONAL

Linerixibat Long-term Safety, and Tolerability Study

This research study is about checking the long-term safety and how well people tolerate a medicine called linerixibat. It's for patients who have a liver condition called cholestasis, specifically primary biliary cholangitis (PBC), which often causes bothersome itching. This study is only for those who have already taken linerixibat in an earlier trial. Participants will continue to receive linerixibat, and doctors will carefully monitor them over time. The study will continue until it officially ends or until the medicine becomes widely available. The exact time each person spends in the study will depend on when they join.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

242

Start

14 Jul 2020

Estimated completion

30 Sep 2026

Cholestasis

What is this study about?

Imagine you have a liver condition called cholestasis, which can make you feel very itchy, especially if you have primary biliary cholangitis (PBC). This study is for people who have already been part of a research trial looking into a specific medicine called linerixibat for this itching. The main goal of this new study is to understand its safety when taken over a longer period. Since you've already tried linerixibat, this is an opportunity to continue receiving it and help researchers learn more about its long-term effects.

In medicine, before new treatments can be widely used, they go through several stages of testing. This study is a 'Phase 3' study, which means the medicine has already been through earlier tests and is now being studied more extensively to confirm its safety and how well people tolerate it over a longer time. Researchers will keep a close eye on all participants, making sure the medicine continues to be safe and noting any side effects that might come up.

By taking part, you'll be helping doctors gather crucial information that could, in the future, help many other people with similar liver conditions. Your experience contributes to a better understanding of linerixibat and whether it can be a safe and effective long-term option for managing the itching associated with PBC.

Key takeaways

This study is for long-term safety of linerixibat.
Only for people who already took linerixibat in a previous study.
Helps understand the medicine's effects over time.
Requires regular check-ups and medical tests.
Participation helps future patients with cholestasis.

Who may be eligible?

To join this study, you must be between 18 and 80 years old. A really important point is that you must have already taken part in a specific previous study involving the medicine linerixibat. This means you would have already been diagnosed with primary biliary cholangitis (PBC) and had the associated itching that led you to the previous trial.

There are also some health conditions that would prevent you from joining. For example, if you have certain levels of liver problems, kidney issues, or other serious health problems like active viral hepatitis or certain types of cancer, you wouldn't be able to participate. It's also not for women who are pregnant or breastfeeding, but women who are unable to have children or are using effective contraception can take part. You also shouldn't have had bariatric surgery in the past 3 years, or at any time if it involved an ileal bypass, and shouldn't be using another specific medication called Obeticholic acid.

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 between 18 and 80 years old?
Have you already participated in a specific linerixibat study for PBC and itching?
Are you not pregnant or breastfeeding, and if you could have children, are you using reliable birth control?
Have you been told you don't have severe liver or kidney problems?
Have you been told you don't have certain other serious health issues like active hepatitis, specific cancers, or certain past surgeries?
Are you not currently taking a medicine called Obeticholic acid?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will continue to take the medicine linerixibat. Since this is an extension of a previous trial you were in, the specific medication and how you take it will likely be familiar to you. Doctors and nurses will check on your health regularly to make sure the medicine is still safe for you and to see if you have any side effects. This involves clinic visits where you might have blood tests and other assessments.

The study will continue until it officially ends, or until linerixibat becomes available to everyone. This means the total time you spend in the study could vary. It might be shorter or longer depending on when you join and when the study finishes in your country. You will be told exactly what's involved in your participation during the informed consent process.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of staying in this study is continuing to receive linerixibat, which you may have found helpful for your itching. By participating, you also contribute important information that could help others with similar conditions in the future. However, there are potential risks, including side effects from the medicine, or the inconvenience of study visits and tests. You will be closely monitored, but there’s always a chance of unexpected health issues. Remember, you can leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (89)

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

GSK Investigational Site
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Davis, United States
GSK Investigational Site
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West Hollywood, United States
GSK Investigational Site
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Miami, United States
GSK Investigational Site
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Detroit, United States
GSK Investigational Site
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New York, United States
GSK Investigational Site
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Durham, United States
GSK Investigational Site
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Morrisville, United States
GSK Investigational Site
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Philadelphia, United States
GSK Investigational Site
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Dallas, United States
GSK Investigational Site
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Houston, United States
GSK Investigational Site
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Seattle, United States
GSK Investigational Site
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Buenos Aires, Argentina

Common questions

What is the main purpose of this study?

To check the long-term safety and how well people tolerate the medicine linerixibat for itching caused by a liver condition called cholestasis.

Can anyone with cholestasis join this study?

No, this study is only for people who have already taken linerixibat in a specific previous research trial.

What exactly will I have to do if I join?

You will continue to take linerixibat, and attend regular clinic visits for health checks and tests, like blood tests, to monitor your health and the medicine's effects.

How long will I be in this study?

The length of time will vary for each person, depending on when you join and when the study officially ends or the medicine becomes widely available.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.