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 how the drug D-2570 is processed in the body and its safety in adults who have liver problems compared to those with normal liver function. This single-center, non-randomized, open-label study evaluates the pharmacokinetic profile of D-2570, focusing on how the drug moves through the body in different participants. The study includes adults aged 18 to 70 years, both with hepatic impairment and healthy liver function. Participants receive a single oral dose of D-2570 during the study. The study is organized into parallel groups, with participants with liver impairment enrolled first, followed by those with normal liver function. Researchers will monitor how the drug is absorbed, distributed, metabolized, and cleared, using blood samples collected up to 192 hours after dosing. During participation, individuals will undergo assessments to measure drug levels and safety, including monitoring for adverse events up to 9 days after dosing. The study tracks several key pharmacokinetic parameters such as time to maximum plasma concentration, maximum concentration, half-life, area under the curve, clearance, and volume of distribution. The entire study is expected to conclude by November 2026, with a primary completion date in October 2026.

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics two drugs, AZD9550 and AZD6234, in adults with different levels of liver impairment compared to those with normal liver function. This Phase I, open-label study includes participants with severe or moderate hepatic impairment as classified by the Child-Pugh score, as well as matched healthy controls. The goal is to understand how liver problems affect these drugs when given as single subcutaneous doses. Participants will receive separate single doses of AZD9550 and AZD6234 administered subcutaneously in two periods, with a washout period between the doses to reduce interference between drugs. The study groups include those with severe hepatic impairment Child-Pugh Class C, moderate hepatic impairment Child-Pugh Class B, and healthy individuals matched for sex, age, and body mass index. Approximately 16 participants with hepatic impairment and up to 12 healthy controls will be enrolled. During the study, participants will be assessed for drug levels in the body over 56 days after dosing to measure pharmacokinetic parameters such as AUCinf, AUClast, and Cmax. Safety and immune response will also be monitored through laboratory tests, vital signs, electrocardiograms, and adverse event reporting. The study duration includes screening, dosing periods, and follow-up visits to capture these outcomes under medical supervision.

Researchers are conducting an international, multicenter, randomized, controlled, open-label Phase III trial to evaluate the efficacy and safety of libevitug in people with chronic Hepatitis Delta Virus HDV infection. The study aims to compare different doses of libevitug and observe outcomes related to viral load and liver health. Participants will be assigned to one of three groups receiving libevitug at 20 mgkg every two weeks via intravenous infusion for 96 weeks, receiving libevitug at 10 mgkg every two weeks via intravenous infusion for 96 weeks, or being observed for 48 weeks followed by receiving libevitug 20 mgkg every two weeks for 48 weeks. This design allows comparison between dosing regimens and delayed treatment. During the study, participants will undergo regular assessments including measurements of HDV RNA levels, liver enzyme normalization, liver stiffness, and liver function scores over a period extending up to 120 weeks. Safety monitoring will include tracking treatment-emergent adverse events. The primary outcome is the proportion of participants achieving specific viral load and liver enzyme targets by Week 48. Participation involves intravenous infusions and scheduled visits for evaluations and laboratory testing.

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 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 drugs 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 studying how quickly the drug RAY1225 enters and leaves the bloodstream in adults with mild to moderate liver problems compared to those with healthy liver function. This phase 1 trial focuses on understanding the drugs behavior in participants with impaired liver function to gather basic scientific information. Participants are divided into three groups those with mild liver impairment, moderate liver impairment, and normal liver function. Each participant receives a single subcutaneous dose of 3 milligrams of RAY1225. The study measures how the drug is absorbed and processed over a period from day 1 to day 43. Throughout the study, participants undergo various assessments including blood tests to measure drug concentration and monitor for any adverse effects related to the drug. The main outcomes include the area under the drug concentration-time curve and the maximum drug concentration observed. Safety is also tracked by recording any drug-related side effects during the 43-day period. The total participation duration spans approximately six weeks.

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 investigators 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 evaluating the pharmacokinetics and safety of the drug BMS-986435 in adults with normal liver function and those with mild or moderate liver impairment. The study aims to understand how the drug behaves in the body and its safety profile across these different liver function groups. This is a Phase 1, open-label study involving healthy volunteers and participants with hepatic impairment. Participants receive a single specified dose of BMS-986435. The study includes three groups those with mild hepatic impairment, moderate hepatic impairment, and matched participants with normal liver function. The study uses a parallel design and is non-randomized, with no blinding. During the study, participants will undergo assessments up to 45 days after dosing to measure drug concentration levels, including maximum concentration and the area under the concentration-time curve. Safety is monitored by recording adverse events and serious adverse events. Additional measures include drug half-life, time of maximum concentration, clearance, and volume of distribution. Participants must meet specific health criteria including adequate heart and kidney function. The total participation duration extends through these evaluation periods.

Researchers are evaluating the safety and how the body processes the drug INCB123667 when taken orally by adults with moderate or severe liver impairment. This Phase 1, open-label study includes participants with different levels of liver dysfunction to understand the drugs effects and safety in these groups. Participants are divided into two groups one with moderate hepatic impairment and another with severe hepatic impairment. Each participant receives a single oral dose of INCB123667. The study runs from May 2026 to April 2027, with each participant monitored for up to approximately 2.5 months to assess drug levels and safety. During the study, participants will undergo medical history reviews, physical exams, vital sign checks, ECGs, and lab tests to monitor their liver function and overall health. Researchers will measure drug concentrations in the blood and record any treatment-related side effects. Participants involvement includes signing consent forms and adhering to study protocols, with safety closely tracked throughout the study period.