Hepatitis

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 evaluating the pharmacokinetic properties and safety of a drug called AHB-137 injection in adults aged 18 to 65 years who have mild to moderate liver dysfunction as well as those with normal liver function. This study is designed as a Phase 1 clinical trial to better understand how the drug behaves in these different groups and to assess any potential safety concerns. It is sponsored by Ausper Biopharma Co., Ltd. and involves participants with chronic hepatitis B. Participants receive a single subcutaneous injection of AHB-137. The study includes two groups of participants with liver dysfunction classified as Child-Pugh A and Child-Pugh B, along with matched groups of participants with normal liver function. The groups are studied in parallel, and the trial compares how the drug is processed in their bodies. The dosing involves only one administration, and the study duration extends up to 29 days for monitoring. During the study, participants undergo various assessments to measure pharmacokinetic parameters, including peak concentration and drug exposure over time area under the curve up to day 29. Safety indicators are also monitored throughout this period. Participants may have physical exams, laboratory tests, and other procedures to ensure safety and collect data on the drugs behavior. The total participation time lasts up to 29 days following the injection.

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.

This trial evaluates the safety and effectiveness of AHB-137 injection combined with other hepatitis B treatments in adults with HBeAg-negative chronic hepatitis B CHB who are already receiving nucleoside analogue therapy. It is a randomized, open-label, multicenter phase II study designed to find out if this combination can help control the virus better and improve patient outcomes. Participants are assigned to one of several groups receiving AHB-137 along with either pegylated interferon alpha-2b, hepatitis B vaccine, or both. The treatment durations vary, with some groups receiving AHB-137 for 16 or 24 weeks alone or in combination with pegylated interferon for up to 24 weeks. All treatments are administered by injection as part of the study protocol. During the study, participants will have regular assessments including measurements of hepatitis B surface antigen and viral DNA levels, liver enzyme tests, and antibody detection. Safety will be closely monitored through adverse event tracking and quality of life questionnaires. The primary outcome is the proportion of participants maintaining very low hepatitis B markers 24 weeks after stopping treatment, with follow-up assessments lasting up to 72 weeks after treatment completion.

Researchers are evaluating the safety and effectiveness of HRS-5635 injection alone or combined with other treatments in adults with chronic hepatitis B who are already receiving therapy. This Phase II, multicenter, randomized, open-label study aims to better understand how these treatments affect the hepatitis B surface antigen levels in patients with this long-term liver infection. Participants will receive one of several doses of HRS-5635 injection given by subcutaneous injection, either alone or combined with Peg-IFN-, another injected medication. The study includes multiple groups to compare different doses and combinations, with a follow-up period extending up to 72 weeks to monitor changes in virus markers and treatment response. During the study, participants will have regular blood tests to measure hepatitis B surface antigen and other viral markers at specified intervals, including weeks 12, 48, and up to 72. Researchers will also watch for any safety concerns, drug resistance, or changes in viral activity. The total time involved varies depending on the treatment group but includes long-term monitoring of virus levels and treatment effects.

Researchers are establishing a European-wide registry to study patients with chronic hepatitis B virus HBV infection, including those with HBV mono- and co-infections. This registry aims to analyze virus and host-specific factors in these patients, providing important information to better understand HBV control and help classify patients for future immunomodulatory therapy trials. The project also seeks to identify hepatitis B patients interested in participating in upcoming studies focused on immunotherapies such as therapeutic vaccines. The study involves no interventions or treatments but collects detailed clinical and laboratory data from participants. A subgroup called the TherVacB cohort includes patients with stricter inclusion criteria, such as documented chronic HBV infection and specific virological markers. This observational registry will monitor patients over time to gather information without altering their standard medical care. Participants will undergo evaluations including measurement of hepatitis B surface antigen HBsAg levels, seroconversion to anti-HBs antibodies, and quantification of immune markers like IL6, IP-10, IFNg, and IL1beta over five years. Additional assessments cover quality of life, liver health outcomes including cirrhosis and hepatocellular carcinoma, and survival related to hepatitis B. The study will help stratify patients for future clinical trials and improve understanding of HBV infection progression under real-world conditions.

Chronic Hepatitis B virus HBV infection poses a significant public health challenge, particularly in China. Current treatments with interferon or nucleostide analogues NAs achieve sustained Hepatitis B surface antigen HBsAg lossa functional curein less than 10% of patients. This study aims to explore a novel combination therapy that includes an immune checkpoint inhibitor anti-PD-1 antibody alongside NAs to improve the rate of HBsAg loss, targeting over 50% functional cure in treated patients. The research builds on previous findings and intends to restore immune control by reversing T cell exhaustion caused by HBV infection. Participants will receive either a combination of NAs plus anti-PD-1 antibody or NAs alone. The anti-PD-1 antibody is administered subcutaneously or intravenously once every one to three weeks at a dose lower than that used for cancer treatment, while NAs are taken orally once daily. The study is a phase 2, non-randomized clinical trial conducted across multiple centers and expects to compare safety and efficacy outcomes between these groups to assess the potential of immune checkpoint blockade in achieving higher rates of clinical cure. Throughout the study, participants will have their serum HBsAg, HBV DNA, and alanine aminotransferase ALT levels measured at baseline, 24 weeks, 48 weeks after treatment, and 24 weeks post-treatment to monitor response and safety. The study involves regular assessments over a treatment period followed by a post-treatment observation period. Participants will be monitored closely for adverse effects and treatment adherence, contributing to a comprehensive evaluation of this combination strategys impact on chronic HBV infection.

Chronic Hepatitis B virus HBV infection is a significant public health issue in China. Current treatments with interferon alpha IFNb1 or nucleostide analogues NAs achieve sustained loss of Hepatitis B surface antigen HBsAg in less than 10% of patients. Previous research increased this rate to 15% overall and up to 30-50% in patients with lower HBsAg levels using a sequential combination therapy. This trial aims to further improve this functional cure rate by combining immune checkpoint inhibitors targeting the PD-1PD-L1 pathway with IFNb1 to restore T cell function and enhance immune control against HBV. Participants will receive one of two treatment combinations NAs plus anti-PD-1 antibody with Peg-IFNb1, or NAs plus Peg-IFNb1 alone. The anti-PD-1 antibody is administered subcutaneously or intravenously at intervals of one to three weeks at doses lower than those used for cancer. NAs are taken orally once daily, and Peg-IFNb1 is given as a weekly subcutaneous injection. This large multicenter prospective study will evaluate safety, efficacy, and rates of HBsAg loss compared to previous studies. During the study, participants will undergo regular assessments including blood tests for HBsAg, HBV DNA levels, and liver enzyme alanine aminotransferase ALT at baseline, 24 weeks, 48 weeks, and 24 weeks after treatment ends. Researchers will monitor immune response and safety throughout the trial. The study duration and follow-up will allow evaluation of long-term effects and the potential for a clinical cure to reduce the burden of HBV infection toward global elimination goals by 2030.

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 AHB-171 Injection in a Phase I clinical trial to assess its safety, tolerability, immune response, and pharmacokinetics in both healthy adults and adults with chronic hepatitis B CHB. The study also aims to explore the preliminary effectiveness of AHB-171 in CHB participants. This trial includes two parts Part A with healthy participants and Part B with CHB participants receiving background treatment. Participants receive AHB-171 Injection or placebo via subcutaneous injection. CHB participants also continue stable treatment with nucleostide analogue NA orally. Part A focuses on single ascending doses in healthy adults, while Part B involves multiple ascending doses in CHB participants. The study monitors participants for up to 16 weeks in Part A and up to 48 weeks in Part B, assessing various safety and pharmacokinetic parameters. During the study, participants undergo laboratory tests, physical exams, vital sign checks, electrocardiograms, and ultrasound assessments. Researchers track adverse events and measure drug levels in the blood and urine, as well as immune responses against AHB-171. In CHB participants, viral markers and liver function tests are monitored to evaluate treatment effects. Participants are followed closely throughout the study duration, which may last up to 48 weeks depending on the group.