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PredIcting SterOid DepeNdEnt LivEr InjuRy with Polyreactive Immunoglobulin G

Doctors are studying a specific marker in the blood called polyreactive immunoglobulin G (pIgG). This marker might help them accurately diagnose autoimmune hepatitis, a condition where the body's immune system attacks the liver. It's often hard to tell apart from other liver issues, especially drug-induced liver injury that looks similar but usually resolves quickly. By finding this pIgG marker, doctors hope to better understand who has autoimmune hepatitis and who might need long-term treatment. The study will collect a blood sample from people undergoing a liver biopsy and then check in with them six months later to see how their liver condition is progressing and if they need continuous medication.

At a glance

Status
Recruiting
Sponsor
Hannover Medical School
Enrolment target
200
Start
06 Jun 2023
Estimated completion
01 Jan 2027

What is this study about?

This study is looking for a special substance in the blood called polyreactive immunoglobulin G, or pIgG for short. Doctors believe this pIgG could be a helpful tool for understanding some types of liver disease, particularly a condition called autoimmune hepatitis.

Autoimmune hepatitis happens when your body's immune system mistakenly attacks your liver. It can sometimes be difficult for doctors to tell the difference between autoimmune hepatitis and other liver problems, such as liver injury caused by medication, which can look very similar at first. The main difference is that people with autoimmune hepatitis often need ongoing medicine to control their condition, while those with drug-induced injury usually get better quickly without long-term treatment.

The main goal of this study is to see if measuring pIgG in the blood can help doctors make a more accurate and earlier diagnosis of autoimmune hepatitis. This could mean patients get the right treatment sooner, and those with other types of liver injury avoid unnecessary long-term medication. Doctors will collect a blood sample and then follow up to understand whether the patient needs ongoing treatment after six months.

Key takeaways

  • This study investigates a blood marker (pIgG) for liver disease.
  • It aims to help diagnose autoimmune hepatitis more accurately.
  • Participation involves a blood sample during a liver biopsy and a follow-up at six months.
  • It helps distinguish autoimmune hepatitis from other liver injuries.
  • No new medicines or procedures are involved for study participants.
  • The information gained could improve future patient care.

Who may be eligible?

You might be able to join this study if you are getting a liver biopsy to understand the cause of a new liver problem. We need to make sure you haven't started any strong immune-suppressing medicines before your biopsy, as this could affect the results.

However, you won't be able to join if you're having a liver biopsy just to check on a liver condition you already know about, like non-alcoholic fatty liver disease (NAFLD) or Hepatitis B or D.

Basically, we're looking for people who are having their first biopsy to figure out what's causing their liver issues, and who are not already on treatments that could change the immune system's activity.

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.

  1. Are you having a liver biopsy to figure out why your liver isn't well?
  2. Are you not currently on any strong medicines to suppress your immune system?
  3. Is this biopsy to find the cause of a new liver problem, not to check on an existing one like NAFLD or Hepatitis B?
  4. Are you willing to provide written consent to participate?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll need to do is provide a blood sample. This sample will be taken when you are already in the hospital for your liver biopsy. Beyond that, the study will involve a follow-up six months later to see how your liver condition has developed and if you require ongoing medication to manage it. There are no extra hospital visits or special medications for the study itself; we're just collecting information and blood samples during your standard care and then checking in later.

Potential risks and benefits

Taking part in this study is generally considered very low risk. The blood sample will be taken at the same time as other blood tests you might have during your hospital visit. There are no additional medications or procedures involved. The potential benefits are that the findings from this study could help doctors better diagnose and understand liver diseases like autoimmune hepatitis in the future, leading to improved care for others. You are free to withdraw from the study at any time without affecting your medical care.

Locations (8)

  • University Medical Centre Aachen
    Verified postcode
    Aachen, Germany· Recruiting
  • University Hospital Bonn
    Verified postcode
    Bonn, Germany· Recruiting
  • University Medical Center Hamburg-Eppendorf
    Verified postcode
    Hamburg, Germany· Recruiting
  • Hannover Medical School
    Verified postcode
    Hanover, Germany· Recruiting
  • University Medical Center Heidelberg
    Verified postcode
    Heidelberg, Germany· Recruiting
  • University Hospital Schleswig-Holstein, Location Lübeck
    Verified postcode
    Lübeck, Germany· Recruiting
  • University Hospital Magdeburg
    Verified postcode
    Magdeburg, Germany· Recruiting
  • Rostock University Medical Centre
    Verified postcode
    Rostock, Germany· Recruiting

Common questions

What is autoimmune hepatitis?

It's a liver condition where your body's immune system mistakenly attacks your liver cells. It often requires ongoing treatment.

What is pIgG?

pIgG is a specific marker that doctors are looking for in the blood. They believe it could help diagnose autoimmune hepatitis more accurately.

Do I need to take any new medicines for this study?

No, this study does not involve taking any new medications. You will continue to receive the standard care recommended by your doctors.

How long will I be involved in the study?

You'll provide a blood sample at the time of your liver biopsy, and then doctors will follow up with you about six months later to check on your condition.

Will my regular treatment be affected?

No, your regular medical care and treatment decided by your doctors will not be affected by you taking part in this study.

How to find out more

Bastian Engel, Dr.

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

Interested in taking part?

Register your interest

Share your details and the research team for "PredIcting SterOid DepeNdEnt LivEr InjuRy with Polyreactive …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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