Acute Liver Failure

Researchers are investigating the appropriate intensity of rehabilitation programs for patients who have undergone liver transplantation. Cardiovascular disease is a leading cause of death for these patients due to sedentary lifestyle and poor physical fitness after transplant. The study aims to test a structured, home-based, supervised physical rehabilitation and maintenance program in liver transplant recipients, assessing its feasibility, safety, and ability to improve physical fitness. Participants will be randomly assigned to one of three training groups with different exercise intensities: low, moderate, or combined moderate and high intensity. The rehabilitation program lasts six months and includes aerobic, strength, balance, and flexibility exercises performed from home under supervision. After this, a 15-month maintenance phase of physical activity tailored to individual preferences will follow to observe long-term implementation. Participants will undergo assessments at the start, three months, six months, and 15 months after the intervention begins. These evaluations include tests of physical fitness, cardiovascular health, liver function, body composition, and questionnaires monitoring well-being, safety, quality of life, physical activity, and cost-effectiveness. Monthly monitoring of adverse events and follow-ups at the study site will ensure safety and track outcomes over time.

This research aims to learn more about vitamin C deficiency in patients with either acute or chronic diseases. It focuses on understanding how symptoms change over time and how well patients tolerate treatment. The study involves patients diagnosed with vitamin C deficiency either by lab tests or based on symptoms such as fatigue, infections, bleeding gums, joint pain, and poor wound healing. The study observes patients treated with Vitamin C Injektopas® 7.5 g, given for an expected average of about 3 weeks for acute diseases or 12 weeks for chronic diseases. Two groups are included: those with acute underlying diseases and those with chronic underlying diseases, both receiving this vitamin C therapy during the study period. Participants will be followed to assess changes in general and disease-specific symptoms, as well as treatment tolerability and overall effectiveness from the patient's perspective. Researchers will also record the number of vitamin C infusions and measure quality of life for chronic disease patients. The study duration ranges up to approximately 12 weeks, with evaluations at the last visit to understand symptom improvement and treatment impact.

Researchers are studying the long-term risk of liver failure linked to TURALIO14 (pexidartinib) treatment in patients with symptomatic tenosynovial giant cell tumor (TGCT) who have severe symptoms or functional problems and cannot improve with surgery. This study also explores how liver damage happens by examining liver biopsy samples from patients who have or had liver toxicity while on TURALIO14. The goal is to understand liver injury mechanisms and assess safety over time. This is a non-interventional, observational study where no study medication is given. Participants have experienced liver test abnormalities from TURALIO14 treatment. Optional liver biopsies will be taken for detailed analysis of immune cells in the liver. Blood samples will also be collected to monitor liver function, safety, immune cells, and genetics. Participants will be followed yearly for up to 10 years to track liver health and potential failure after stopping TURALIO14. During the study, participants will provide blood samples and may choose to have a liver biopsy for further testing. Researchers will assess liver test results and monitor for signs of liver failure, liver transplant need, or death. Follow-up visits occur at least once per year for 10 years to observe long-term effects. The main outcome measured is how often liver failure occurs after stopping TURALIO14, helping to better understand long-term safety in this group.

Researchers are evaluating a new combined therapy using human albumin and enoxaparin in patients with decompensated cirrhosis who are discharged from the hospital. The study aims to determine if this combined treatment is safe, tolerable, effective, and whether it costs more or less compared to standard medical treatment. This Phase 2 clinical trial will compare patients receiving the combinatorial therapy plus standard care to those receiving only standard care to see how they respond over time. Participants are randomly assigned to one of two groups: one group receives standard medical treatment along with the combined therapy of enoxaparin and human albumin, while the control group receives only standard medical treatment. The study involves treatment and follow-up over a period that includes monitoring at 30, 90, and 180 days after baseline to assess various health outcomes and complications. During the study, participants will attend visits where researchers will perform tests to track disease progression and response to treatment. Assessments include monitoring adverse events such as pulmonary edema, bleeding, and thrombocytopenia, as well as changes in liver and kidney function, hospital readmissions, survival rates, quality of life measures, and overall healthcare costs. Safety and tolerability are closely observed from baseline to day 90, with continued evaluation up to 180 days. Total study participation may last about six months from baseline.

Researchers are studying the safety and how the body processes two drugs, AZD9550 and AZD6234, in people with different levels of liver problems compared to those with normal liver function. This Phase I, open-label study focuses on adults aged 18 to 85 who have severe or moderate hepatic impairment classified by Child-Pugh scores, as well as healthy controls matched for sex, age, and BMI. The study aims to understand how liver impairment affects these drugs' behavior in the body and their safety. Participants will receive a single subcutaneous dose of AZD9550 followed by a washout period, then a single dose of AZD6234. The study includes three groups: those with severe hepatic impairment (Child-Pugh Class C), moderate hepatic impairment (Class B), and healthy individuals with normal liver function. The study will monitor the drugs' pharmacokinetics separately to guide future dosing and safety considerations. During the trial, participants will be closely monitored from day 0 through day 56 for drug concentration levels and safety outcomes. Evaluations include blood tests for drug levels, immune response (antidrug antibodies), vital signs, and lab assessments. The study also tracks how the drugs are absorbed, distributed, metabolized, and eliminated. Participation involves several clinic visits for dosing and follow-up assessments, ensuring careful observation of the drugs' effects over nearly two months.

Researchers are conducting a prospective, multi-center observational study in China to better understand drug-induced liver injury (DILI). The study aims to explore the clinical features, identify the drugs or herbs causing DILI, assess patient outcomes, and discover new serum markers. The goal is to develop and validate a prognostic model incorporating these novel markers to improve prediction of patient prognosis in China. Participants will be grouped into a modeling group to help build a predictive model for DILI outcomes, and a validation group to test the accuracy of this model. The study collects long-term data to establish and verify these prognostic tools. No experimental treatments are given as this is an observational cohort study. During the study, researchers will monitor participants for key outcomes such as death, liver transplantation, and acute liver failure over one year, as well as chronic DILI and recovery over two years. Data will be collected through regular clinical assessments and laboratory tests. This long-term follow-up will help improve understanding of DILI prognosis and validate new serum biomarkers. Participants will be involved over extended periods to ensure comprehensive outcome measurement.

This research aims to understand patients with drug-induced liver injury (DILI) in various hospitals across mainland China, including Western medicine, Chinese medicine, integrated hospitals, and specialist hospitals for conditions like tuberculosis. The study focuses on evaluating the clinical characteristics, progression, and influencing factors of DILI in real-world clinical practice. It also seeks to learn about suspected drugs causing DILI, rechallenging, and patterns of liver biochemical abnormalities. The study is a multi-center, prospective, non-interventional cohort study that observes patients without providing experimental treatment. It involves different cohorts receiving standard care or treatments such as compound glycyrrhizin tablets/injection, isoglycyrrhizinate magnesium injection, diammonium glycyrrhizinate capsules, bicyclol, silibinin capsules, ursodeoxycholic acid capsules, and N-acetylcysteine. The study will assess compliance with DILI guidelines, histological features, and specific populations including elderly and children with liver disease backgrounds. Participants will be monitored over time to observe disease progression including outcomes like death, liver failure, chronic DILI, or recovery within six months. Researchers will collect clinical data, liver function tests, and other relevant information to evaluate the course of DILI and factors affecting outcomes. The study will continue until December 2030, focusing on real-world data without altering patient treatment plans.

Researchers are investigating the use of 18F-DFA PET imaging to evaluate liver injury, a condition involving rapid liver function decline with symptoms like increased liver enzymes, jaundice, and abdominal discomfort. This observational study aims to assess how accurately this imaging method detects liver damage compared to standard clinical biochemical tests and liver biopsy, which is the current gold standard despite its sampling limitations. The study focuses on adults clinically diagnosed with liver damage or liver failure, exploring the correlation between 18F-DFA uptake in the liver and liver function indicators. Participants diagnosed with liver injury will undergo 18F-DFA PET imaging as part of the study. This radioactive tracer, based on vitamin C structure, is used to visualize liver function non-invasively. The imaging process involves a PET-CT scan lasting about 10 minutes, followed by a one-hour waiting period in the examination room before leaving. The study will compare imaging results with clinical liver function tests or liver biopsy findings to determine the sensitivity and specificity of this method. During the study, participants will have their liver function monitored using PET-CT scans and clinical biochemical markers. The primary outcomes include changes in liver uptake values on PET imaging at 6 months and the relationship between imaging results and standard liver function indicators. Participants will be followed up as needed, with assessments including liver enzyme levels and other blood tests. The total study duration depends on individual follow-up, and safety monitoring will address any issues related to PET imaging procedures.

Researchers are studying calderasib (MK-1084) to understand how its levels change over time in the body, focusing on both people with liver (hepatic) impairment and healthy volunteers. The study also aims to learn about the safety and tolerance of MK-1084 in those with liver impairment. This is a Phase 1 clinical trial sponsored by Merck Sharp & Dohme LLC. All participants will receive a single oral dose of calderasib on the first day of the study. The trial involves measuring calderasib levels at specific times up to about 7 days after dosing to analyze how the drug is processed in the body. Researchers will look at various pharmacokinetic measures such as drug concentration, clearance, and half-life. Participants will be closely monitored through blood sampling and assessments to measure drug levels and safety up to approximately 14 days after the dose. The study will record any adverse events and track whether participants discontinue due to side effects. Overall participation time and follow-up will cover up to two weeks after dosing, focusing on how the drug behaves and is tolerated in people with and without liver impairment.

Researchers are evaluating the effect of liver function impairment on how the drug HDM1002 behaves in the blood. The study focuses on adults aged 18 to 70, including those with normal liver function and varying degrees of liver impairment. This Phase 1 trial aims to understand the drug's pharmacokinetics, safety, and tolerability in these different groups. Participants receive a single dose of HDM1002 on the first day of the study. The study includes separate groups for people without hepatic impairment and those with mild, moderate, or severe hepatic impairment. Researchers compare how the drug is processed in the body across these groups. During the trial, blood samples will be collected at multiple time points up to 72 hours after dosing to measure drug concentration and binding in plasma. Safety and tolerability are monitored throughout. The study is randomized and open-label, with participation lasting through the sampling period. The trial is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.