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Drug-Induced Liver Injury clinical trials

View clinical trials related to Drug-Induced Liver Injury.

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NCT ID: NCT06446609 Recruiting - Pruritus Clinical Trials

Drug-induced Liver Injury: Itching Study

Start date: June 14, 2024
Phase:
Study type: Observational

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.

NCT ID: NCT06192589 Recruiting - Drug Interaction Clinical Trials

Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions

Start date: February 8, 2024
Phase: Phase 1
Study type: Interventional

Cannabidiol (CBD) is available as a prescription drug product for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. At labeled doses up to 25 mg/kg/day, an increased risk of liver enzyme elevation and drug-induced liver injury has been observed. However, only limited evaluations of the risk of liver enzyme elevation of daily, lower dose CBD use are available. The potential for liver enzyme elevations with lower CBD doses with unapproved consumer products highlights a need for further research. In addition, CBD has the capacity to inhibit cytochrome P450 enzymes and uridine 5'-diphospho-glucuronosyltransferases, leading to potential drug-drug interactions with multiple common medications. The clinical significance of many of these interactions is also unclear. Furthermore, nonclinical studies have suggested the potential for CBD to cause reproductive and endocrine effects. As such, additional high-quality clinical pharmacology studies are needed to further characterize CBD's safety profile. The objective of this study is to characterize the effects of daily CBD use at a dose within the range of what consumers are taking as unapproved CBD products on liver enzyme elevations, drug interactions, and endocrine measures.

NCT ID: NCT06019936 Recruiting - Clinical trials for Drug-Induced Liver Injury

A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects

Start date: August 10, 2023
Phase: Phase 2
Study type: Interventional

The goal of this randomized, double-blind, placebo controlled, Multicenter Phase II clinical trial is to initially evaluate the Safety and Efficacy of MT2004 Capsule in Cholestatic and Mixed drug induced liver injury (DILI) subjects. The main questions it aims to answer are: 1. The Efficacy of MT2004 Capsule in Cholestatic and Mixed DILI subjects 2. The Safety and Pharmacokinetic characteristic of MT2004 Capsule in Cholestatic and Mixed DILI subjects 3. The mechanism of using MT2004 Capsule on Cholestatic and Mixed DILI subjects

NCT ID: NCT05789797 Recruiting - Cancer Clinical Trials

Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy

Start date: May 12, 2022
Phase:
Study type: Observational

Cancer has moved from the tenth place to the second one over the last 100 years, being inferior to only cardiovascular diseases in morbidity and mortality. 40 % of hepatitis cases in patients older than 40 years and 25 % of cases of fulminant hepatic failure (FHF) are caused by drug hepatic toxicity. Cases of acute drug-induced hepatitis (ADIH) make 15-20 % of patients with fulminant hepatitis in Western Europe.

NCT ID: NCT05738681 Recruiting - Tuberculosis Clinical Trials

Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial

Start date: September 9, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

To determine the efficacy of NAC to prevent clinically significant anti-TB drugs induced liver injury (AT-DILI).

NCT ID: NCT05517668 Recruiting - Liver Failure Clinical Trials

Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose

Start date: September 12, 2022
Phase: Phase 2
Study type: Interventional

This study is a randomized, placebo-controlled double-blinded clinical trial of patients presenting with acetaminophen poisoning who are at increased risk of developing liver injury. With this trial the investigators are hoping to show the superiority of acetylcysteine (NAC) + fomepizole (4-MP) compared to treatment with acetylcysteine alone. The primary objective of this trial is to determine the effect of fomepizole on the severity of acute liver injury in patients with acetaminophen poisoning.

NCT ID: NCT05465642 Recruiting - Gut Microbiota Clinical Trials

Alterations of Gut Microbiota and Serum Biochemical Markers in DILI Patients

Start date: July 4, 2022
Phase:
Study type: Observational [Patient Registry]

Drug-induced liver injury is a leading cause of acute liver failure worldwide and one of the least understood areas in hepatology research. Increasing evidence has shown that drug-induced liver injury is associated with gut microbiota.

NCT ID: NCT05060289 Recruiting - Clinical trials for Drug-induced Liver Injury

A Prognostic Model for Drug-induced Liver Injury in China

DILI-PM
Start date: May 25, 2022
Phase:
Study type: Observational [Patient Registry]

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 .

NCT ID: NCT04964310 Recruiting - Clinical trials for Drug-Induced Liver Injury

Screening of Susceptibility Genes for APAP Induced Drug Induced LIver Injury in ChiNese Population: a Case-control Study

PAIN
Start date: August 31, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT04625166 Recruiting - Hepatitis B Clinical Trials

Combi-elastography Assessment of Chronic Liver Disease Multi-center Study

Start date: December 1, 2020
Phase:
Study type: Observational

HITACH developed a new combi-elastography imaging technology combines shear wave imaging and strain imaging technology. In the study, not only the F index which is related to the stage of liver fibrosis can be obtained, but also the A index which is related to the stage of hepatitis can be obtained, which can not be obtained by other ultrasound devices.