Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Effectiveness and Safety of Prednisone for Patients with Drug-Induced Liver Injury (DILI)

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication prednisone in treating a condition known as idiosyncratic hepatotoxicity. Idiosyncratic hepatotoxicity is a type of liver damage that occurs unpredictably and is not related to the dose of a drug. The study will compare the effects of prednisone to a placebo to determine if prednisone is beneficial and safe for patients with this liver condition.

Participants in the study will receive either prednisone or a placebo in the form of tablets taken orally. The treatment will last for a period of five weeks. The main goal is to see if prednisone can help reduce the levels of a substance in the blood called total bilirubin (TBL), which is often elevated in liver damage. The study will also monitor the safety and tolerance of prednisone in patients with moderate to severe drug-induced liver injury (DILI), which is a type of liver damage caused by medications.

Throughout the study, researchers will observe how quickly TBL levels return to normal and will also track any side effects or adverse events that occur. The study aims to provide insights into whether prednisone can effectively and safely help patients with liver damage caused by medications. Participants will be closely monitored to ensure their safety and to gather valuable data on the treatment's impact on liver health.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and diagnosis of drug-induced liver injury (DILI).

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate liver function and overall health. This includes measuring levels of liver enzymes and bilirubin.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of prednisone in the form of a 5 mg tablet taken orally. The treatment duration is five weeks.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring occurs throughout the treatment period to assess the effectiveness and safety of prednisone. This includes checking for a reduction in liver enzyme levels and bilirubin.

    Follow-up visits are scheduled to track progress and any side effects. The primary goal is to achieve a 50% reduction in bilirubin levels by day 14.

  5. Step 5

    Completion of treatment

    At the end of the five-week treatment period, a final assessment is conducted to evaluate the overall impact of the treatment on liver function.

    A quality of life questionnaire is completed to assess any changes from the start to the end of the treatment.

Who can join the trial?

4 criteria

  • Female and male patients who are **18 years or older** can participate.
  • Patients must have been diagnosed with **DILI** (Drug-Induced Liver Injury) by a group of experts.
  • Patients should have **moderate to severe DILI**, which means their liver enzymes, called **ALT** or **AST**, are at least 5 times higher than normal, and their **TBL** (Total Bilirubin Level) is at least 2.5 mg/dL.
  • Patients whose **ALT** values do not decrease by 15% or whose **TBL** continues to rise 5-10 days after stopping the drug causing liver damage are eligible.

Who cannot join the trial?

7 criteria

  • Patients with a history of **liver damage** caused by medications or other substances. **Liver damage** means the liver is hurt and not working properly.
  • Patients who are not within the specified age range for the study. This means the study is only for people of certain ages.
  • Patients who are part of a vulnerable population. This means people who might need extra protection or care, like children or pregnant women.
  • Patients who have other medical conditions that might interfere with the study. This means if you have other health problems, you might not be able to join.
  • Patients who are taking medications that could affect the study results. This means if you are on certain drugs, you might not be able to participate.
  • Patients who have allergies or reactions to the study medication. This means if you are allergic to the medicine being tested, you cannot join.
  • Patients who are unable to follow the study procedures. This means if you cannot do what the study requires, you might not be able to participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Prednisone is a medication being studied for its potential benefits in treating idiosyncratic hepatotoxicity, which is a type of liver damage. In this clinical trial, researchers are evaluating whether taking prednisone can help reduce liver damage by decreasing the levels of a substance called TBL in the blood. They are also looking at how quickly prednisone can help return TBL levels to normal. Additionally, the trial is assessing the safety and tolerability of prednisone in patients with acute moderate to severe drug-induced liver injury (DILI).

What is already known about the treatment

Prednisone – Prednisone is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness and safety in treating idiosyncratic hepatotoxicity, a condition where the liver is damaged due to unpredictable reactions to drugs. The main therapeutic indication for prednisone in this trial is to reduce liver damage and improve liver function. At the molecular level, prednisone works by suppressing the immune system and reducing inflammation, which helps in decreasing liver damage. It is classified as a corticosteroid, a type of medication that mimics the effects of hormones produced by the adrenal glands.

Investigated diseases

Hepatotoxicity – Hepatotoxicity refers to liver damage caused by chemical substances, often medications or toxins. It can manifest as an increase in liver enzymes, indicating liver cell injury. Symptoms may include jaundice, fatigue, and abdominal pain. The condition can progress to more severe liver dysfunction if the offending substance is not identified and removed. In some cases, it may lead to acute liver failure, requiring medical intervention. Monitoring liver function tests is crucial in managing and understanding the progression of hepatotoxicity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513004-33-00Protocol codeDILICORT-2024Estimated enrolment60 patientsSponsorFundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.