This is a Phase 2, randomized, double-blind, double-dummy,
placebo-controlled study evaluating the efficacy and safety of SEMA,
CILO/FIR, and their combination in subjects with compensated
cirrhosis due to NASH.
Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 parts - Part 1 and Part 2.
The purpose of this study is to create a de-identified, public use,
repository of data of Chronic Obstructive Pulmonary Disease (COPD)
patients with by Alpha-1 antitrypsin deficiency (AATD), a rare genetic
condition that can cause COPD and emphysema.
This investigator-initiated research study supported by a pilot grant from MUSC-Siemens research collaboration, aims to test the feasibility and reproducibility of Ultrasound Shear wave elastography as a point of care tool in screening for hepatic fibrosis and steatosis in children 9-17 years of age with Non-Alcoholic Fatty Liver Disease.
This Phase 2b study is a randomized, double-blind, parallel-arm, placebo-controlled trial to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg compared with placebo in subjects with NASH. Subjects will be randomized 1:1:1 to receive Saroglitazar Magnesium 4 mg, Saroglitazar Magnesium 2 mg, or placebo via IVRS/IWRS. Total duration of the study will be up to 89 weeks including two screening visits (12 weeks), randomization and double-blind treatment phase (76 weeks), and a safety follow-up of 1 week after the last administration of study drug. Subjects will be evaluated at the study site for 14 scheduled visits. During the course of the study subjects will have 2 liver biopsies and 6 transient elastography/FibroScan performed to monitor liver fibrosis.
This is an Open-label Extension Phase 3 Study to determine whether a study drug called maralixibat is safe and effective in treating itchy skin (pruritus) in children with Progressive Familial Intrahepatic Cholestasis (PFIC). There is currently no treatment approved for PFIC and available medical approaches have limited success.
Open label means both the investigators and the subjects are aware of the drug or treatment being given
A Phase 3 study is large scale trial to confirm and expand information on safety and usefulness of a new drug.
Subjects who participate in this study will receive the study drug. The dose of the study drug will be gradually increased during the study up to a tolerable dose . Subjects will continue to take the medication for about 26 months. Subjects will have approximately 16 study visits over 26 months in this study. Subjects will also be asked questions about health and complete questionnaires at the study visits and as well as at home. A Physical exam and Liver ultrasound will be performed at some study visits. A blood and urine sample will also be collected at some of the study visits.
It is possible that the maralixibat may or may not improve symptoms from PFIC. Even if there is no benefit, other children may benefit from what is learned in this study.
The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.
There is a new investigational drug called DUR-928. This study is being done to see if this investigational drug helps in the treatment of Alcoholic Hepatitis (AH).
The hope is that the use of DUR-928 will lead to lowering the MELD (Model for end-stage liver disease) score, some other liver blood tests, and then other symptoms of AH may get better.
The purpose of this study is to find out about the safety and effectiveness of an investigation drug called Semaglutide for the treatment of NASH. (Non-Alcoholic Steatohepatitis). NASH occurs when the fat buildup in the liver leads to inflammation (hepatitis) and scarring. NASH is associated with increased risk of morbidity (medical problem or complication) and mortality (death). Currently, treatment options are few and insufficient. There is therefore an unmet medical need for effective and safe pharmacological treatment options. The study is designed to last 257 weeks (approximately 4 years and 11 months), with study visits occurring approximately every 4 weeks. Most visits will include blood work and some will include assessments such as body weight and vital signs. Most visits will include reviewing of diary entries during the course of the study. This study also includes weekly injections of semaglutide (or placebo). Semaglutide is a self-administered injection that is given under the skin. Semaglutide has built an extensive amount of data with other trials that have focused on weight management and Type 2 diabetes. Semaglutide is FDA-approved for diabetes treatment, but is investigational for this study. In these previous trials, semaglutide was found to be safe and well-tolerated. This study is randomized, double-blinded, and placebo-controlled. This means that you may receive the study drug or a placebo. Neither the study subject or the study team members will know which each subject will be receiving. Study subjects will be randomized 2:1. This means that subjects will have a greater chance (66%) of receiving the drug versus the placebo.