Hepatitis A

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 protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo (aluminum hydroxide adjuvant) injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups: treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccine's impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

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 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.

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 evaluating how moderate or severe liver impairment affects the way the body processes the drug inavolisib. This open-label Phase 1 study will compare participants with moderate or severe hepatic impairment to healthy participants with normal liver function to assess the drug's pharmacokinetics, safety, and tolerability. The study is sponsored by Genentech, Inc. and aims to better understand inavolisib's behavior in different liver conditions. Participants will receive a single oral dose of inavolisib on Day 1. The study includes three groups: healthy participants with normal liver function, participants with moderate hepatic impairment, and participants with severe hepatic impairment. Each participant will take one dose of the drug, and no placebo or randomization is involved as all receive the active drug. During the study, researchers will collect blood samples at multiple timepoints up to 96 hours post-dose to measure the drug concentration and calculate pharmacokinetic parameters such as maximum concentration and area under the curve. Safety will be monitored through adverse event reporting up to Day 8. The entire participation involves screening, single dose administration, pharmacokinetic sampling, and follow-up for safety assessment.

Researchers are evaluating the combination of tobevibart and elebsiran in adults aged 18 to 70 years with chronic Hepatitis D Virus (HDV) infection who have not achieved viral suppression with bulevirtide treatment. This Phase 3, randomized, open-label trial aims to assess the efficacy and safety of this combination therapy for participants who continue to have active HDV infection despite prior treatment with bulevirtide. The study is sponsored by Vir Biotechnology, Inc. and addresses a critical need for improved therapeutic options in this population. Participants will be assigned to one of two groups. One group will receive tobevibart plus elebsiran together for up to 240 weeks. The second group will continue bulevirtide treatment for 24 weeks before switching to the combination of tobevibart and elebsiran for the remaining 216 weeks. All drugs are given by subcutaneous injection. This design allows comparison of continued bulevirtide versus switching to the new combination therapy over a long-term period. During the study, participants will have their HDV RNA levels measured at multiple time points, including week 24, and up to 24 weeks after treatment ends, to evaluate viral suppression. Researchers will also monitor liver enzyme changes and record any treatment-related side effects through week 240. Safety assessments and laboratory tests will be conducted regularly throughout the study. The total duration for individual participation may be up to approximately 4.5 years, including extended follow-up to assess long-term outcomes and safety.

Researchers are studying how decreased liver function affects the way the body processes the study medicine PF-07328948. This study aims to understand differences in medicine processing among people with various levels of liver impairment compared to those without liver problems. It is a Phase 1, open-label trial focusing on pharmacokinetics, safety, and tolerability of PF-07328948 in adults aged 18 to 75 years. Participants will receive a single oral dose of one PF-07328948 tablet at the study clinic. Four groups are included: those with severe, moderate, and mild hepatic impairment, and those without liver impairment. Each participant will stay onsite for about 6 days following dosing, during which their treatment experience and blood levels of PF-07328948 will be closely monitored. During the study, staff will collect blood samples at multiple time points up to 168 hours after dosing to measure unbound drug levels in plasma. Safety will be assessed by recording any treatment-related side effects up to 36 days. Participants must comply with scheduled visits, tests, and procedures during their stay. The total body weight and BMI of participants will also be evaluated to ensure eligibility.