Drug Induced Liver Injury

Elevated liver enzymes are common laboratory abnormalities that may result from alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease (NAFLD). Persistent elevation of liver enzymes may indicate ongoing hepatocellular injury and increase the risk of progressive liver disease. Current management primarily focuses on treating the underlying cause and providing supportive care, while evidence for effective hepatoprotective therapies remains limited. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of Misocholic Tab, a film-coated herbal medicine, in adults with mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) associated with alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease. Eligible participants will be randomly assigned in a 1:1 ratio to receive either Misocholic Tab or matching placebo for 30 days. Both groups will receive standard background therapy with silymarin. The primary objective is to compare the change in serum ALT and AST levels from baseline to Day 30 between the two treatment groups. Secondary objectives include evaluating the proportion of participants whose liver enzyme levels return to the normal range and assessing the safety of Misocholic Tab through clinical evaluation, laboratory testing, and monitoring of adverse events.

Drug-induced liver injury (DILI) is an important cause of acute liver damage that occurs when prescription medications, over-the-counter drugs, herbal products, or dietary supplements harm the liver. DILI can range from mild abnormalities in liver enzymes that cause no symptoms to severe conditions such as acute liver failure, the need for an urgent liver transplant, or death. Diagnosing DILI is often challenging because it shares symptoms with many other liver diseases, and there are currently no single specific blood tests to confirm it. There is limited data regarding the prevalence, causative agents, and clinical outcomes of DILI among patients in Upper Egypt. The main purpose of this study is to: 1. Determine the hospital-based prevalence of DILI among adult patients attending Al-Rajhi Liver Hospital, Assiut University Hospitals. 2. Identify the most common medications, herbal preparations, and supplements causing liver injury. 3. Categorize the patterns of liver injury (hepatocellular, cholestatic, or mixed) using standardized biochemical calculations (R-ratio). 4. Evaluate patient outcomes and identify clinical and laboratory factors that predict unfavorable outcomes, such as acute liver failure, liver transplantation, or death. The study is an observational study conducted over a two-year period using two approaches: * A retrospective chart review of adult patients diagnosed with DILI during the first year. * A prospective follow-up of consecutive adult patients who present with DILI during the second year. Participants will receive standard medical care as directed by their treating physicians. Routine medical data, laboratory tests, imaging results, and treatment details will be recorded and analyzed to help improve the early detection, prevention, and management of DILI in clinical practice.

Idiosyncratic drug-induced liver injury (DILI) is an unpredictable adverse hepatic reaction to a medication used in its therapeutic dose. DILI is the second most common cause of itching in adult Hepatology after biliary obstruction. In particular cholestatic or mixed pattern types of DILI (in which bile flow from the liver is impaired) are associated with long-lasting effects as well as reduced quality of life. There is therefore an urgent need to determine the incidence and natural history of itching in DILI and establish a network of centres that will form a basis for a clinical trial to investigate a novel intervention to treat these.

The purpose of this study is to establish retrospectively a nationwide registry of patients who have suffered drug-induced liver injury (DILI), and to collect, immortalize, and store serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for subsequent mechanistic investigations into the basis of severe idiosyncratic DILI. The primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of individuals who have experienced severe DILI and the relevant clinical data concerning the episode of DILI; and, (b) to create a bank of biological specimens obtained from these individuals. These biological specimens will be DNA, plasma, and immortalized lymphocytes. Immortalized lymphocytes will provide unlimited amounts of genomic DNA for study as well as living immune cells for phenotyping studies. A secondary goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD database so that they may be recontacted in the future. It is expected that this will facilitate additional studies exploring the mechanisms of DILI.

This is a retrospective, multicenter real-world observational study. Its main goal is to find out if Polyene Phosphatidylcholine Injection works to treat drug-induced liver injury (DILI) in adults with hematologic malignancies, and to check if the drug is safe. It also aims to answer these key questions: Does Polyene Phosphatidylcholine Injection help prevent DILI in people with hematologic malignancies? How effective and safe are different combinations of Polyene Phosphatidylcholine Injection with other liver-protective drugs for DILI? Which DILI treatment plan offers better value for money? Who can take part? Participants must meet all these criteria: 18 years or older (no gender restriction) Diagnosed with a hematologic malignancy (such as leukemia, lymphoma, or multiple myeloma) Received at least one cycle of chemotherapy that may harm the liver Used Polyene Phosphatidylcholine Injection to treat or prevent DILI (alone or with one/two specific liver-protective drugs: Magnesium Isoglycyrrhizinate Injection, Glutathione Injection, Ademetionine 1,4-Butanedisulfonate Injection/Tablets, Ursodeoxycholic Acid Oral Formulation, or Bicyclol Tablets) Had liver function tests within 7 days before starting treatment and at least once after starting treatment What will the study involve? Researchers will look back at medical records of eligible participants treated on or before November 30, 2025. They will collect and analyze: Participants' basic information (age, gender) and disease details Details about Polyene Phosphatidylcholine Injection use (dose, frequency, duration) Liver function test results (including alanine aminotransferase \[ALT, a liver enzyme that rises when the liver is injured\], aspartate aminotransferase \[AST\], total bilirubin \[TBIL\], and other related indicators) at different time points (3 days, 7 days, 14 days, 21 days, 30 days, 60 days) after starting treatment Any unwanted health issues (adverse events, AEs) during treatment and how they were managed Costs related to treatment (drug fees, test fees, AE management fees) What are the key things researchers will measure? Main measure: How well ALT levels improve 7 days after starting Polyene Phosphatidylcholine Injection (defined as ALT dropping by more than 50% or returning to normal) Secondary measures: Improvement in liver function indicators at other time points (3 days, 14 days, 21 days, 30 days, 60 days) How well the drug prevents DILI (how often DILI occurs and how severe it is) Differences in effectiveness and safety between different drug combinations Which treatment plan is more cost-effective

Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.

A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers. A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .

OBJECTIVE : To compare the outcome of treatment with silymarin or N-acetyl cysteine in patients taking anti-tuberculous drugs for tuberculosis at Tertiary Care Hospital, Karachi. SAMPLE SELECTION : Patients presenting with tuberculosis previously not on anti-tuberculous drugs, between 40-80 years of age, both genders will be included .Patients with history of alcohol use,Discontinuation of drug due to other adverse effects except hepatotoxicity ,Inadequate date of laboratory testing at baseline or 2 to 4 weeks after treatment initiation, Cases with human immunodeficiency virus (HIV) co-infection, viral hepatitis, or suspected mal absorption (e.g., gastrointestinal disease or diarrhea) ,Chronic liver disease, COPD, asthma, myocardial infarction, chronic kidney disease and stroke will be excluded

This is a multi-center, prospective, non-interventional cohort study . Its primary objectives are: 1. assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice; 2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.

Acetaminophen (APAP) is the most commonly used NSAIDS in clinic, and it is also a common cause of drug-induced liver injury (DILI). In 2012, the proportion of DILI caused by APAP in the United States was 51%, while in Asia, it was only 7.10%. Previously, a small cohort study in the United States screened for some of the susceptibility genes for DILI due to APAP by the Genome wide association study (GWAS) method. However, the genetic susceptibility loci based on the US cohort were not applicable to the Chinese population. Therefore, we make a study design include Chinese population who ingested APAP and divided them into case group and control group according to the occurrence of DILI. We hope to be able to find the root of differences at the genetic level and explore new pathogenic mechanisms.

DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease. Asia-Pacifc region is characterized by two unique features; the high prevalence of tuberculosis (TB) in the population and the ubiquitous use of traditional and complimentary medicines.Current definition of Hy's law presents significant difficulties when dealing with patients with preexisting CLD in clinical trials. Hallmark of the hepatic manifestation in these patients is hyperbilirubinemia and coagulopathy rather than ALT elevation.

A total of 407 hospitalized patients with acute liver injury in Beijing Friendship Hospital Affiliated to Capital Medical University were enrolled. The clinical information, biochemical examination, imageological examination (ultrasound, CT, MRI) and liver biopsy pathology of patients with acute liver injury will be collected. The diagnostic efficacy of RECAM and RUCAM in the diagnosis of DILI will be compared, and the consistency of different clinicians in the diagnosis of DILI using RECAM and RUCAM scores will also be compared.