Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease
Alcoholic Liver DiseaseA Phase I clinical trial to determine the safety and tolerability of an anti-IL23 antibody for the treatment of patients with alcoholic liver disease
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic...
Non-Alcoholic Fatty Liver DiseaseA 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)
TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic...
Non-cirrhoticChronic Hepatitis BThe main goal of therapy for patients with chronic HBV infection with no significant liver disease is to improve survival and quality of life by preventing disease progression, development of liver cirrhosis and consequently HCC development. The likelihood of achieving these goals depends on the timing of therapy during the natural course of the infection but also on the stage of the disease and the patients' age when treatment is started. The inhibition of viral replication and normalization of ALT by antiviral treatment has been shown to achieve the elimination of chronic HBV-induced necroinflammatory activity and progressive fibrotic liver progression in the vast majority of patients, in turn reducing the risk of HCC. Even in HBeAg positive patients, treatment-induced HBeAg loss and seroconversion to antiHBe characterizes the induction of a partial immune control often leading to a low replicative phase of the chronic HBV infection and good outcomes. Treatment in chronic HBV infection is indicated in - presence of advanced fibrosis/cirrhosis (LSM >11 KPA) or patients with significant fibrosis (LSM >8 or APRI >1.5 or >F2 on liver biopsy) with high viral load (>2000 IU/ml) or significantly elevated ALT (x2 ULN). Presence of any of these factors is known to increase the risk of development of cirrhosis and hepatocellular carcinoma. TAF in non-cirrhotic patients (LSM <8 KPA) with normal ALT and low viral load (HBV DNA <2000 IU/ml) (currently treatment ineligible) as compared to delayed initiation (on demand) might reduce HCC risk, progression of liver fibrosis and reduction in HBsAg levels. As TAF is known to have favorable effects on the overall long-term outcome, the main clinical challenge is to identify the patients at risk of HCC and cirrhosis who warrant early antiviral therapy.
RESTORE Declined Livers Study
Liver DiseasesSurgery2 moreThis is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. Liver transplant outcomes will be ascertained during 12 months post-transplantation. The results of the trial will be compared with those of contemporary comparison groups of patients who received the standard criteria donor liver transplantation.
Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen...
HIV InfectionsFatty Liver DiseaseIn HIV-infected people with metabolic fatty liver disease and liver fibrosis of any degree, as measured by non-invasive testing, antiretroviral treatment that includes rilpivinire for 18 months results in a slowing of progression and/or reduction of fatty metabolic liver disease, attenuating inflammation and liver fibrosis.
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
Hepatic ImpairmentThe aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Liver DiseasesPatients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving quality of life, and improving patient experience.
Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients:...
Metabolic Associated Fatty Liver DiseaseThe goal of this single arm, prospective study is to test the therapeutic response of oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks in non-diabetic MAFLD patients. The primary outcomes are the improvement of liver inflammation or fibrosis parameters after 24 weeks treatment. The adverse events were also recorded.
A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants...
Hepatic ImpairmentThe primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function.
Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib...
Non-small Cell Lung CancerTo assess the efficacy and safety of Almonertinib therapy in patients with abnormal liver function after first/second generation EGFR-TKI treatment, or Almonertinib first-line therapy in patients with basic hepatopathy and locally advanced or metastatic EGFR-mutant non-small cell lung cancer.