Hepatitis D

Researchers are studying chronic liver diseases and tumors, including non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), cirrhosis, and hepatocellular carcinoma (HCC). These conditions can be caused by viral infections like hepatitis B, C, and D or lifestyle factors such as overeating and lack of exercise. The goal is to develop better understanding and new treatments by analyzing liver tissues and tumors at the single-cell level to identify therapeutic targets and improve patient outcomes. The study involves creating patient-derived preclinical models, such as spheroid cultures and mouse xenograft models, to test new treatment strategies. Blood samples and tissue biopsies are collected during surgeries, biopsies, or diagnostic tests. Researchers use advanced molecular techniques like single-cell RNA sequencing to examine tumor heterogeneity and the liver environment, aiming to discover new biomarkers and treatment predictors. Participants will undergo procedures as part of their care, including hepato-bilio-pancreatic surgery, biopsies, or locoregional treatments. Blood samples are taken during these procedures to support research. Researchers will monitor surgery outcomes over an average of eight years. By studying patient samples and clinical data, the team aims to improve personalized medicine approaches and identify new preventive and therapeutic targets for chronic liver diseases and liver cancer.

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 evaluating the efficacy and safety of libevitug, an intravenous drug, in participants with chronic Hepatitis Delta Virus (HDV) infection. This international, multicenter, randomized, controlled, open-label Phase III trial aims to compare different doses of libevitug and a control group to understand its impact on viral levels and liver function. The study includes participants aged 12 to 70 years with chronic HDV infection lasting at least six months. Participants will be randomly assigned to one of three groups: a group receiving libevitug 20 mg/kg every two weeks for 96 weeks, a group receiving libevitug 10 mg/kg every two weeks for 96 weeks, or a control group observed for 48 weeks before starting libevitug 20 mg/kg every two weeks for the remaining 48 weeks. Treatment is administered by intravenous infusion. The control group allows comparison of immediate versus delayed treatment effects. During the study, participants will undergo regular assessments including blood tests to measure HDV RNA levels and liver enzyme (ALT) normalization. Liver stiffness and liver function scores will also be monitored up to 96 weeks, with clinical events and safety data collected through week 120. The primary outcome is the proportion of participants achieving significant reduction or undetectable HDV RNA and ALT normalization at Week 48. Participants can expect to attend frequent study visits for these evaluations throughout the study period.

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.

Researchers are evaluating how nemtabrutinib, a drug given by mouth, behaves in the blood (pharmacokinetics) after a single dose in people with moderate liver impairment compared to healthy individuals. The study also aims to assess the safety and tolerability of nemtabrutinib in these participants. This is a Phase 1 clinical trial sponsored by Merck Sharp & Dohme LLC. Participants with moderate hepatic impairment and healthy matched controls each receive one oral dose of 25 mg nemtabrutinib on Day 1. The study groups include those with moderate liver impairment classified by specific medical criteria and healthy volunteers. Both groups receive the same dosage and form of the drug. Participants will have multiple blood samples taken before and at various times up to 336 hours after dosing to measure drug levels and related pharmacokinetic parameters. Safety is monitored through adverse event reports up to about 15 days. The total study duration includes dosing and follow-up assessments to evaluate how the drug is processed and tolerated in the body.

The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.

Researchers are investigating the relationship between the volume of normal liver tissue removed during surgery, called resected normal liver parenchymal volume (RNLV), and the risk of liver failure after liver surgery (post-hepatetotomy liver failure, or PHLF). This observational study focuses on patients diagnosed with hepatocellular carcinoma (HCC) or intracholangiocarcinoma (ICC) who have undergone liver resection. The goal is to build and assess a personalized predictive model using RNLV to better estimate the risk of PHLF before surgery. The study collects data retrospectively from over a thousand patients treated at the investigator’s center. Patients are grouped based on whether they developed liver failure after surgery, defined by two sets of criteria known as the 50-50 criteria and ISGLS criteria. The research evaluates how well the RNLV-based model predicts PHLF and compares its usefulness to other methods, especially for patients with large or multiple liver tumors. Participants' medical records and surgical details are reviewed to calculate RNLV and assess liver failure outcomes within 30 days after surgery. The main outcome is the predicted probability of PHLF using the newly developed model. This approach aims to improve preoperative risk assessment to support safer liver surgeries. The study is sponsored by the National Natural Science Foundation of China and runs through the end of 2026.

Researchers are studying EDG-7500 to understand how it behaves in the blood after a single dose in adults with different levels of liver function, including those with normal liver function and those with mild or moderate hepatic impairment. This Phase 1 trial also evaluates the safety of EDG-7500 in these groups to see how liver impairment affects the drug's presence and tolerability. Participants receive one oral dose of EDG-7500. The study includes three groups: healthy adults with normal liver function, adults with mild hepatic impairment, and adults with moderate hepatic impairment. The trial is open-label, meaning all participants know they are receiving EDG-7500. There are no placebo groups or blinding methods used. During the study, researchers monitor the amount of EDG-7500 in the blood over time, up to 10 days after dosing, measuring key levels such as maximum concentration and overall exposure. Safety is also tracked by observing any treatment-related side effects for up to 14 days. Participants undergo health assessments including blood tests, vital signs, and heart monitoring to ensure safety throughout the study timeline, which starts with screening and continues through follow-up.