Hepatitis C

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 establishing a prospective group of patients with plasma cell disorders (PCDs) to better understand these conditions and their treatments. This study focuses on various PCDs including multiple myeloma, amyloidosis, and other related disorders. It aims to explore how minimal residual disease (MRD) status relates to patient prognosis and investigate the role of the tumor microenvironment (TME) in the disease's development and progression. Patients with confirmed PCDs who are hospitalized and willing to participate will be followed over time. Biological samples such as peripheral blood, bone marrow aspirate, and urine will be collected before and after treatment to support future research. The study does not involve any intervention and participants will be regularly assessed at baseline, then at 1, 3, 6, and 12 months after treatment, followed by yearly visits. During the study, clinical and laboratory data along with biological samples will be gathered to analyze disease features and treatment responses. Follow-up visits will monitor patient progress and outcomes for up to ten years. The main outcome is to maintain a comprehensive cohort and understand the relationship between MRD and prognosis in PCD patients, while also supporting further studies on tumor clone evolution and disease mechanisms.

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 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 effectiveness of low volume Transanal Irrigation (TAI) using the Qufora IrriSedo MiniGo device combined with standard conservative treatments compared to conservative treatment alone for patients with Low Anterior Resection Syndrome (LARS). This condition affects individuals who have undergone surgery for rectal cancer. The study aims to assess improvements in clinical symptoms of LARS over a three-month period. Participants are divided into two groups: one receiving low volume TAI with the MiniGo device plus standard conservative care, which includes dietary management, counseling, and prescribed medications excluding suppositories and physiotherapy; and another group receiving only the standard conservative treatments. The study includes follow-ups at 6 weeks, 3 months, and up to 12 months to monitor various outcomes. During the study, participants will be regularly assessed using the LARS score to measure symptom changes, quality of life questionnaires (EORTC QLQ-C30 and QLQ-CR29), incontinence scores, patient satisfaction, treatment compliance, bowel management time, and healthcare resource usage. Data will be collected at multiple intervals including 6 weeks, 3 months, 6 months, 9 months, and 12 months to thoroughly evaluate the treatment impact and patient preferences.

Researchers are evaluating a pilot intervention aimed at reducing HIV and hepatitis C virus (HCV) transmission, as well as overdose risk behaviors, among people who inject drugs (PWID). The study uses a peer-driven approach targeting semi-public injection settings (SPIS) to promote safer practices. This intervention is grounded in social influence, social network, and social cognitive theories, focusing on improving communication and peer education to change social norms around risk behaviors. Participants will be randomly assigned to one of two groups: one receiving behavioral training with six sessions that include peer education and stocking of SPIS with risk reduction materials, and the other receiving an attention control (standard care). The intervention seeks to increase conversations about prevention and the availability of naloxone and other risk reduction materials in injection settings to reduce sharing of injection equipment and overdose risks. During the study, 120 index PWID participants will be selected based on their use of SPIS. Their involvement includes participation in the training sessions or control activities, with researchers monitoring overdose prevention and HIV/HCV prevention outcomes over six months. Assessments will include measures of overdose behaviors and related risk factors to evaluate how well the intervention influences these outcomes over time.

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.