Clichy

Researchers are evaluating the use of multiparametric dynamic whole-body 68GaGa-PSMA PETCT imaging in patients newly diagnosed with hepatocellular carcinoma HCC or those with recent suspicion of refractory, residual, or recurrent disease. The study aims to assess how this imaging technique performs diagnostically and to explore kinetic modeling in this patient population. Participants receive a dynamic whole-body 68GaGa-PSMA PETCT scan as the investigational procedure. This involves the administration of 68GaGa-PSMA-11 as a radiation-based imaging agent. The study does not mention multiple treatment groups or comparators and focuses on detailed imaging acquisition and analysis. During the study, participants undergo imaging assessments at baseline and follow-up evaluations over six months to measure diagnostic performance, comfort during the procedure, and compare dynamic versus static imaging approaches. Researchers will collect kinetic parameters and evaluate the imaging results at both lesion and patient levels. The total study involvement includes baseline imaging and follow-up assessments within a six-month period to monitor outcomes and safety.

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

This research aims to describe the clinical, histological, and radiological features of rare primary liver cancers. It focuses on collecting tumor and blood samples to better understand these cancers and to evaluate how well treatments used in real-world practice work, with the goal of identifying the best treatment sequences. The study serves as a foundation for future research to find new molecular and imaging biomarkers that could improve diagnosis and prognosis. The study is observational and retrospective, meaning it reviews past cases from multiple centers in France. It collects biological samples and clinical data from patients diagnosed with rare primary liver cancers after January 2018. The study evaluates treatments patients have received in clinical practice without assigning any new treatments or interventions. Participants data, including clinical characteristics, tumor biology, and imaging, will be reviewed for up to five years from diagnosis. Researchers will measure outcomes such as recurrence-free survival for patients without metastases, progression-free survival for those with metastases, and overall survival. The study includes both living patients who consent to participate and deceased patients, aiming to gather comprehensive information to support future translational studies.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating a new combined therapy using human albumin and enoxaparin in patients with decompensated cirrhosis who are discharged from the hospital. The study aims to determine if this combined treatment is safe, tolerable, effective, and whether it costs more or less compared to standard medical treatment. This Phase 2 clinical trial will compare patients receiving the combinatorial therapy plus standard care to those receiving only standard care to see how they respond over time. Participants are randomly assigned to one of two groups one group receives standard medical treatment along with the combined therapy of enoxaparin and human albumin, while the control group receives only standard medical treatment. The study involves treatment and follow-up over a period that includes monitoring at 30, 90, and 180 days after baseline to assess various health outcomes and complications. During the study, participants will attend visits where researchers will perform tests to track disease progression and response to treatment. Assessments include monitoring adverse events such as pulmonary edema, bleeding, and thrombocytopenia, as well as changes in liver and kidney function, hospital readmissions, survival rates, quality of life measures, and overall healthcare costs. Safety and tolerability are closely observed from baseline to day 90, with continued evaluation up to 180 days. Total study participation may last about six months from baseline.

Researchers are evaluating the safety, tolerability, how the body processes and responds to the drug, and the anti-tumor activity of BGB-B2033 alone and in combination with tislelizumab, with or without bevacizumab. This first-in-human study focuses on participants with locally advanced or metastatic solid tumors including hepatocellular carcinoma, alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors, and glypican-3-positive squamous non-small cell lung cancer. The trial aims to determine safe dosage levels and preliminary effectiveness in these advanced cancer types. Participants receive intravenous infusions of BGB-B2033 either alone or combined with tislelizumab and bevacizumab in several dose escalation and expansion cohorts. The study includes ascending doses of BGB-B2033 monotherapy, combination therapies to find maximum tolerated doses and recommended doses for further testing, and safety expansion groups. Some participants are from Asian countries and others from the United States, focusing on hepatocellular carcinoma in these regions. Throughout the study, participants are closely monitored for adverse events and responses to treatment for up to approximately 2 years. Assessments include safety evaluations, measuring tumor responses by independent review and investigators, pharmacokinetic and pharmacodynamic tests, and antibody development against the study drug. Tumor tissue samples are required for certain parts of the study. This comprehensive follow-up helps researchers understand the study drugs activity and safety in advanced cancers.

Researchers are evaluating the effects of ersodetug as an additional treatment to standard care for patients who have Tumor Hyperinsulinism Tumor HI, a condition causing low blood sugar due to hormone overproduction by certain tumors that cannot be removed or treated satisfactorily with current therapies. This Phase 3 study aims to assess the blood sugar control, safety, and tolerability of ersodetug in this patient group. Participants will receive weekly doses of ersodetug at 9 mgkg for 8 weeks alongside their usual hypoglycemia treatments. The study is organized into three parts a screening period lasting up to 4 weeks, an 8-week treatment phase, and either an end-of-study follow-up period of up to 20 weeks or an optional open-label extension lasting up to 3 years. Approximately 16 participants diagnosed with tumor HI will take part across several international study sites. During the study, participants will be monitored for changes in their need for intravenous glucose, including the main outcome of whether their glucose infusion rate decreases meaningfully after 8 weeks. Researchers will also track other measures such as total daily glucose delivery and the time needed to stop IV glucose after starting ersodetug. Safety assessments and follow-up visits will continue after treatment for up to 20 weeks or longer if participants choose the extension phase.

Researchers are evaluating efruxifermin EFX in a phase 3, randomized, double-blind, placebo-controlled study involving adults with compensated cirrhosis caused by NASH Nonalcoholic Steatohepatitis or MASH Metabolic Dysfunction-Associated Steatohepatitis. This study aims to assess the safety and effectiveness of EFX in preventing significant clinical events such as disease progression and liver decompensation over a period of up to 5 years. Participants are randomly assigned to receive either efruxifermin 50 mg or a placebo, both given by subcutaneous injection. The study includes two cohorts one with biopsy-proven compensated cirrhosis and specific metabolic scores, and another with biopsy-proven or non-invasive diagnosis of compensated cirrhosis. The study treatment and monitoring extend up to 5 years, with evaluations at 96 weeks and long-term follow-up to track liver fibrosis, markers of liver injury, insulin sensitivity, glycemic control, body weight, and safety outcomes. During the trial, participants undergo regular assessments including laboratory tests, ECGs, ultrasounds, and vital sign monitoring. Researchers will measure changes in liver fibrosis, steatohepatitis resolution, and metabolic markers throughout the study. Safety and tolerability are closely tracked by documenting adverse events and exposure duration. The study duration allows for long-term observation of treatment effects and disease progression, with participant involvement lasting up to 5 years.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating the safety and effectiveness of 48 weeks of daily oral treatment with ALG-000184 compared to tenofovir disproxil fumarate TDF in adults with chronic hepatitis B virus HBV infection. This Phase 2 randomized, double-blind, active-controlled study includes both untreated HBeAg-positive and HBeAg-negative adults. The study aims to understand how well these treatments control HBV infection and their safety profiles. Participants will receive either ALG-000184 or TDF tablets once daily for 48 weeks. After this double-blind period, all participants may continue treatment with open-label ALG-000184 for an additional 48 weeks, making a total treatment duration of 96 weeks. The study is divided into two parts, focusing separately on HBeAg-positive and HBeAg-negative subjects, with some taking part in an exploratory liver biopsy sub-study. Throughout the study, participants will undergo regular assessments including measuring HBV DNA levels to see if the virus is suppressed below a set detection limit at 48 weeks. Safety and tolerability will be monitored up to 96 weeks. Other evaluations include liver enzyme levels, viral resistance, and drug pharmacokinetics. The study involves blood tests, liver assessments, and ongoing monitoring to track treatment effects and participant health over nearly two years.