Clichy

Researchers are evaluating the use of multiparametric dynamic whole-body [68Ga]Ga-PSMA PET/CT imaging in patients newly diagnosed with hepatocellular carcinoma (HCC) or those with recent suspicion of refractory, residual, or recurrent HCC. The study aims to assess the diagnostic performance of this imaging technique over a 6-month period to better understand its impact and utility in managing HCC. Participants will undergo dynamic whole-body [68Ga]Ga-PSMA-11 PET/CT imaging. This involves a specialized radiation-based imaging acquisition designed to provide detailed information about HCC lesions. The study includes patients with confirmed or suspected HCC lesions who meet specific clinical and radiological criteria and are scheduled for biopsy or require further diagnostic imaging due to suspected disease persistence or recurrence. During the study, participants will be monitored for diagnostic outcomes and safety. Researchers will evaluate morphological lesions using established criteria like mRECIST 1.1 through contrast-enhanced CT or MRI scans. Participants must have a performance status of 0 to 2 and a life expectancy of at least 6 months. Safety monitoring includes assessment of hypersensitivity reactions, cardiac function, and other medical or psychiatric conditions. The study also requires adherence to contraception guidelines following the radiotracer injection. Overall, participant involvement includes imaging, clinical evaluations, and follow-up assessments over the study duration.

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are conducting a French multicenter retrospective study to describe the clinical, histological, and radiological features of rare primary liver cancers. The study aims to collect biological tumor and blood samples and evaluate the effectiveness of treatments used in clinical practice to determine the best therapeutic sequences. This research will serve as the foundation for future translational studies to identify new molecular, histological, circulating, and radiological tumor biomarkers useful for diagnosis, prognosis, and treatment guidance. This study involves collecting data from patients diagnosed with rare liver cancers such as hepatocholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, and hepatic angiosarcoma since January 1, 2018. Both living patients who agree to participate and deceased patients are included. Biological samples and tumor blocks are collected for analysis. Treatments received by patients in routine practice are reviewed to assess their efficacy and help define optimal treatment sequences. Participants provide consent for biological studies if living, and their medical records and tumor characteristics are reviewed. Researchers will describe the clinical, histological, and radiological tumor features and monitor outcomes up to five years from diagnosis. This detailed data collection supports long-term evaluation of rare liver cancers and aids in developing future biomarkers and therapeutic strategies.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating a new combination treatment using human albumin and enoxaparin in patients with decompensated cirrhosis who are at high risk of poor outcomes after hospital discharge. This phase 2 trial aims to determine if this combined therapy is safe, tolerable, and effective compared to standard medical treatment. The study also explores whether this approach is more or less costly than current standard care. Participants will be assigned to either the experimental group receiving the combination therapy along with standard treatment or to the control group receiving only standard treatment. Human albumin, a plasma expander commonly used in liver disease, and enoxaparin, an anticoagulant that works by binding to antithrombin III, are given as part of the combinatorial therapy. Standard medical treatment is not specified in the protocol but will be provided to all participants. During the study, participants will attend multiple visits where various tests will monitor their disease progression and response to treatment. Safety will be assessed by tracking treatment-emergent adverse events such as pulmonary edema, major bleeding, or thrombocytopenia from baseline to day 90. Researchers will evaluate tolerability and effectiveness throughout the study period, which includes follow-up visits to observe outcomes and side effects over three months.

Researchers are evaluating the safety, tolerability, how the body processes, and the anti-tumor activity of a drug called BGB-B2033 alone and in combination with tislelizumab, with or without bevacizumab. This first-in-human Phase 1 study includes participants who have locally advanced or metastatic hepatocellular carcinoma, alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors or non-dysgerminomas, and glypican-3-positive squamous non-small cell lung cancer. Participants will receive BGB-B2033 through intravenous infusion either alone or combined with tislelizumab, and sometimes with bevacizumab given by intravenous infusion as well. The study evaluates different dosing levels to find the maximum tolerated dose and the recommended dose for Phase 2. Treatment will be monitored over approximately two years in various parts of the study. During the study, participants will have tumor tissue samples collected and undergo assessments including safety monitoring for adverse events, evaluations of tumor response by an independent review committee, and tests to understand drug effects and dosing. The study will measure overall response rates and track safety and tolerability over up to about two years, with ongoing monitoring of health and treatment effects.

Researchers are evaluating the safety, tolerability, and blood sugar control effects of ersodetug when added to standard treatments in patients with Tumor Hyperinsulinism (Tumor HI). This condition involves low blood sugar caused by hormone overproduction from tumors that cannot be removed or adequately treated with current therapies. The study is a Phase 3 trial including about 16 participants diagnosed with insulin- or IGF-producing tumors. Participants will receive weekly doses of ersodetug at 9 mg/kg along with their usual hypoglycemia treatments for 8 weeks. The study is organized into three periods: up to 4 weeks of screening, 8 weeks of treatment, and then either a follow-up period lasting up to 20 weeks after the last dose or an optional open-label extension phase lasting up to 3 years. The trial is conducted at 10 to 15 sites across approximately 5 countries. Throughout the study, participants will be closely monitored for changes in their glucose infusion needs, which is the primary measure of treatment effect after 8 weeks. Researchers will also assess safety and tolerability during and after treatment. The study involves biochemical tests, clinical evaluations, and continuous monitoring to ensure participant well-being and collect data on treatment response and side effects during the follow-up or extension phases.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating the safety and effectiveness of a new oral medicine called ALG-000184 compared with tenofovir disproxil fumarate (TDF) in adults with chronic hepatitis B virus (HBV) infection. This Phase 2 study includes people who have never been treated or are currently not treated, and it focuses on both HBeAg-positive and HBeAg-negative participants. The study aims to understand how well these treatments control the virus over time. Participants will receive either ALG-000184 or TDF as a once-daily oral tablet for 48 weeks in a randomized, double-blind setting. After this period, all participants have the option to continue treatment with ALG-000184 alone for an additional 48 weeks in an open-label extension. The study includes two parts: one for HBeAg-positive subjects and one for HBeAg-negative subjects, each with the possibility of joining a liver biopsy sub-study. During the study, participants will be regularly monitored for viral levels, specifically measuring HBV DNA to see if it falls below a certain limit after 48 weeks. Researchers will also check safety and liver health through blood tests and imaging. The total study involvement can last up to 96 weeks, including the treatment extension. The study looks closely at how the virus responds to treatment and the overall health of participants throughout this time.