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

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What is this study about?

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.

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 initial assessment

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

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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Costa del Sol	Marbella	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hhtpxeph Ussacwiyklkin Db Lr Pbyaldcw	Madrid	Spain
Hvthclzj Uoqizzrvgaqhr Mbzxatu Df Vbctrsbgsu	Santander	Spain
Pbyz Tuwhx Hwnvtmsg Usuylczbginy	Sabadell	Spain
Hrvkacnw Ufbyqlqoowqmc Dgdryqbo	Donostia / San Sebastian	Spain
Hmvqmzjw Dp Lz Skeho Cqqt I Sxzu Pyy	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.07.2024

Trial locations

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).

Investigated diseases:

Hepatotoxicity

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 ID:

2024-513004-33-00

Protocol code:

DILICORT-2024

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?