Ongoing Clinical Trials for Hepatotoxicity
There is currently 1 ongoing clinical trial investigating treatment options for hepatotoxicity, a condition where the liver becomes damaged due to chemical substances or medications. This trial is exploring whether prednisone, a corticosteroid medication, can help reduce liver damage and improve recovery in patients with drug-induced liver injury.
Clinical trial locations
Study on the Effectiveness and Safety of Prednisone for Patients with Drug-Induced Liver Injury (DILI)
This clinical trial is investigating whether prednisone can effectively and safely treat patients with drug-induced liver injury, also known as DILI. The study focuses on a specific type of liver damage called idiosyncratic hepatotoxicity, which occurs unpredictably and is not related to the dose of the medication that caused it.
Main inclusion criteria:
- Patients must be at least 18 years old, both males and females
- A confirmed diagnosis of DILI by medical experts
- Moderate to severe DILI, meaning liver enzymes called ALT or AST are at least 5 times higher than normal levels
- Total bilirubin levels (TBL) must be 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 that caused the liver damage
Main exclusion criteria:
- History of previous liver damage caused by medications or other substances
- Patients outside the specified age range
- Vulnerable populations requiring extra protection, such as pregnant women
- Other medical conditions that might interfere with the study
- Taking medications that could affect the study results
- Allergies or reactions to prednisone
- Inability to follow the study procedures
Trial focus and goals:
The main goal of this study is to determine whether prednisone can help reduce levels of total bilirubin in the blood, which is often elevated when the liver is damaged. The researchers aim to achieve a 50% reduction in bilirubin levels by day 14 of treatment. The trial will also monitor how quickly bilirubin levels return to normal and track any side effects or adverse events that occur during treatment.
Participants will be compared to those receiving a placebo to determine if prednisone provides real benefits. Throughout the five-week treatment period, regular monitoring will occur to assess liver function through measurements of liver enzymes and bilirubin. At the end of treatment, participants will complete a quality of life questionnaire to assess any changes from the beginning to the end of the study.
Investigational drug:
The medication being tested is prednisone, a corticosteroid that works by suppressing the immune system and reducing inflammation in the body. In this trial, prednisone is administered as a 5 mg tablet taken orally. The treatment lasts for five weeks. Prednisone mimics the effects of hormones naturally produced by the adrenal glands and may help decrease liver damage by reducing inflammation.
Summary
Currently, there is one active clinical trial investigating treatment options for hepatotoxicity, specifically focusing on drug-induced liver injury. This trial is being conducted in Spain and is evaluating the effectiveness and safety of prednisone, a corticosteroid medication, in patients with moderate to severe DILI.
The study targets patients whose liver damage has not improved after stopping the medication that caused the injury, offering a potential treatment option for those with persistent or worsening symptoms. The trial’s primary focus is on reducing bilirubin levels, which are a key indicator of liver function and damage. By monitoring both the effectiveness of prednisone and its safety profile over a five-week period, researchers hope to provide valuable insights into whether this medication can help patients recover from drug-induced liver injury more quickly and safely.
