RecruitingOBSERVATIONAL

Drug-induced Liver Injury: Itching Study

This study is looking into a problem called drug-induced liver injury (DILI), which is when medicines cause unexpected liver damage. A big issue for some people with DILI, especially those whose natural bile flow from the liver is affected, is severe and long-lasting itching. This itching can really impact their daily lives. We don't fully understand why some people get this itching and how it progresses. The main goal of this research is to gather more information about how often this itching happens in people with DILI and how it changes over time. By doing this, we hope to set up a network of hospitals and clinics for future studies. This will help us test new treatments to relieve this difficult itching and improve the quality of life for those affected.

At a glance

Status

Recruiting

Sponsor

University of Nottingham

Enrolment target

Start

30 Jun 2025

Estimated completion

01 May 2028

Drug Induced Liver Injury Pruritus

What is this study about?

Imagine your liver is like a filter for your body. Sometimes, medicines that are meant to help can unexpectedly cause damage to this filter. This is called drug-induced liver injury, or DILI. It’s quite rare, but it can be serious.

One common and uncomfortable problem for people with DILI, especially when the bile, a fluid that helps digestion, doesn't flow properly from the liver, is severe itching. This isn't just a mild itch; it can be persistent and really affect someone's daily life and how they feel. We know this itching is a big deal for patients, and it can last for a long time even after the main liver problem starts to get better.

This study aims to understand this itching much better. We want to find out how many people with DILI experience this itching, how it develops, and what makes it better or worse. By understanding this, we can begin to look for better ways to treat it and help people feel more comfortable. Ultimately, this research will lay the groundwork for future clinical trials to test new treatments for this specific and distressing symptom.

Key takeaways

This study aims to understand liver damage caused by medicines (DILI) and the severe itching that can come with it.
Itching can be a long-lasting and difficult symptom for people with DILI.
The research will help doctors understand how common this itching is and how it progresses.
No new treatments are being tested in this specific study, but the findings will help develop future treatments.
The study focuses on adults with suspected DILI and specific liver blood test results.
It excludes people with other itching conditions like eczema or certain liver infections.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older, and be able to understand what the study involves and agree to take part in writing.

Doctors will need to have diagnosed you with suspected acute DILI. This means your blood tests for liver function would show certain levels that are much higher than normal, indicating liver injury. These blood tests would need to be from around the time you join the study.

However, you wouldn't be able to join if you have other skin conditions that cause itching, like eczema or hives. Also, if you have certain blood-borne liver infections such as Hepatitis B, C, or E, you wouldn’t be able to take part in this particular study.

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 suspected Drug-Induced Liver Injury (DILI)?
Do your recent liver blood tests show specific high levels of liver enzymes (ALT or alkaline phosphatase) or raised bilirubin?
Do you NOT have eczema or urticaria (hives) as a reason for itching?
Do you NOT have Hepatitis B, C, or E?

Answer every question to see your result.

What does participation involve?

The information provided does not detail the specifics of participation, such as the number of visits, assessments, or the duration of involvement. This study is focused on gathering information about DILI and itching to prepare for future treatment studies. Therefore, it's likely to involve sharing your medical history related to your DILI diagnosis and symptoms, and potentially providing blood samples for analysis. You would not be given a new drug as part of this specific data-gathering study. The exact duration and follow-up would be explained if you were invited to participate.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers better understand DILI and the associated itching. This knowledge could lead to better treatments for you and other patients in the future. As this study mainly involves gathering information and not testing a new drug, direct risks might be minimal, potentially limited to discomfort from blood tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Nottingham University Hospitals NHS Trust
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is DILI?

DILI stands for Drug-Induced Liver Injury. It's when a medicine unexpectedly causes damage to your liver.

Why is this study focusing on itching?

Severe itching is a common and very uncomfortable symptom for many people with DILI, especially when their bile flow is affected. This study aims to understand it better to find ways to treat it.

Will I be given a new medication in this study?

No, this particular study is about gathering information to understand DILI and itching better. It's not testing a new treatment, but the information gathered could help in future studies that do.

What does 'cholestatic' mean?

Cholestatic refers to a type of DILI where the flow of bile, a fluid made by your liver, is reduced or blocked. This can often lead to itching.

How long will I need to be involved in the study?

The information provided doesn't specify the exact duration. If you are eligible, the research team will explain the full time commitment needed.

How to find out more

Elinor Study Coordinator

elinor.cross@nottingham.ac.uk 0115 7484390 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.