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 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 the safety and effectiveness of AHB-137 injection combined with other hepatitis B treatments in adults aged 18 to 65 who have HBeAg-negative chronic hepatitis B and are already treated with nucleoside or nucleotide analogues. This phase II, randomized, open-label, multicenter study aims to understand how well this combination controls the virus and improves patient outcomes. The study is sponsored by Ausper Biopharma Co., Ltd. Participants will receive AHB-137 injections combined with either pegylated interferon alpha-2b (Peg-IFN), hepatitis B vaccine, or both, in various treatment durations up to 24 weeks depending on the study group. The study includes multiple experimental groups receiving different combinations and durations of these treatments to evaluate their combined effects. Treatment effects and safety will be monitored during and after therapy. During the study, participants will have regular assessments including blood tests to measure hepatitis B virus markers like HBsAg, HBV DNA, and others, liver enzyme levels, and immune responses. Researchers will also track quality of life, depressive symptoms, and possible adverse events up to 72 weeks. The primary goal is to observe the proportion of participants achieving viral suppression after stopping all treatment, with follow-up visits to monitor relapse and safety. Total participation duration may extend up to 72 weeks post-treatment.

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-α, 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 nucleos(t)ide analogues (NAs) achieve sustained Hepatitis B surface antigen (HBsAg) loss—a functional cure—in 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 strategy's 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 nucleos(t)ide 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-1/PD-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.

This clinical trial evaluates the safety, tolerability, immune response, and pharmacokinetics of AHB-171 Injection in two groups: healthy adults and adults with chronic hepatitis B (CHB). It also assesses the preliminary effectiveness of AHB-171 in participants with CHB. The study is a Phase I trial sponsored by Ausper Biopharma Co., Ltd., aiming to gather important data on this investigational drug. Participants receive AHB-171 Injection or a placebo through subcutaneous injection. The study has two parts: Part A involves healthy participants receiving single ascending doses and monitoring up to 16 weeks, while Part B includes CHB participants receiving multiple ascending doses alongside background nucleos(t)ide analogue treatment, with follow-up up to 48 weeks. Both parts involve randomization and are conducted under quadruple masking. During the study, participants undergo various assessments including laboratory tests, electrocardiograms, physical exams, and vital sign monitoring. Researchers will measure drug levels in the blood and urine, immune responses, and liver-related markers such as hepatitis B surface antigen levels and liver enzyme ALT. Safety is closely monitored through reporting of adverse events and clinical evaluations. The study duration varies up to 48 weeks depending on the group and includes detailed pharmacokinetic and pharmacodynamic analyses.

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.