This is a Phase 3, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of GS-9674 in subjects with PSC
The study will consist of an 8-week Screening period,96 weeks of treatment, and a follow-up visit 4 weeks after completion of treatment. (Patients would be required to come to MUSC for 12 visits for a physical check-up, blood work, and to receive more study medication).
If the subject qualifies they will be randomized into one of two groups. The two groups include one receiving 100mg active GS-9674 or placebo. There is a 2/3 chance to be receiving active drug over placebo. The drug GS-9674 is a capsule that is taken once a day in the morning (with or without food).
The purpose of this study is to see if GS-9674 slows the scarring process in subjects with PSC.
TheraSphere® is a humanitarian use device (HUD) for treating cancer that originates in the liver. TheraSphere® consists of millions of tiny glass beads containing radioactive yttrium-90. The glass radioactive beads (20-30 micrometers in diameter ? about a third of the width of a human hair) are delivered directly to the liver tumors. It can be used to downstage tumors to become eligible for surgery or transplantation. It is also the only medical device approved in the United States to treat primary liver cancer patients with portal vein thrombosis (PVT). TheraSphere® has been approved as an HUD based upon its safety and probable benefit.
The purpose of this study is to see if Rifaximin Soluble Solid Dispersion (SSD) Tablets are safe, well-tolerated, and whether they can better treat overt hepatic encephalopathy, a complication associated with liver cirrhosis, when compared to a placebo (an inactive substance).
This is a clinical research study of an investigational new drug that is being developed as a possible treatment in patients with hepatic insufficiency, cirrhosis and or/elevated blood ammonia levels. Ammonia is a substance that is built during the breakdown of the proteins in blood; in case of errors in the breakdown of proteins, ammonia levels might increase. Elevated ammonia may lead to other medical conditions. The study will help to determine the safety and tolerability of the study medication in male and female patients; in addition, the study investigates the study medications pharmacokinetics and pharmacodynamics.
This study is an inpatient study.
This study consists of 2 parts (part 1 and part 2). However our institution will only be taking part in part 2 of the study (described below) because recruitment for part one has been closed (as indicated by our sponsors).
Patients will initially present for a screening visit where eligibility will be determined. If patients are eligible for this study they will be admitted to an inpatient unit for a total of 12 days. During the 12 days of hospital stay, patients will receive study drug/placebo, regulated diet (predetermined as per study protocol) and several blood tests will be withdrawn measuring serum ammonia levels during this hospital stay. Once patients are discharged from hospital stay, they will be expected to follow up 1 week and 70 days after last study drug/placebo was administered (i.e last day in the hospital) with a stool sample.
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
This an observational study that aims to assess the outcome of patients with advanced fibrosis and cirrhosis recurrence in patients with hepatitis C virus (HCV) infection after HCV eradication. We aim to describe this unique group of patients as well as determine whether any particular variables are significant predictors of fibrosis/cirrhosis resolution. A multivariate analysis will be conducted to determine risk factors independently related to fibrosis/cirrhosis resolution and clinical outcome.
Non-Alcoholic fatty liver disease is the most common liver disease, and involves fat deposition in the liver. The fat in the liver can lead to inflammation, scarring, end stage liver disease and potential liver cancer. Some patients with fat in their liver do not see these changes, and our current understanding of why some people are not affected while others see progression of their disease is poor. We are currently in process of initiating studies to learn more about fatty liver disease, and having a database of patients at the VA medical center who are willing to participate in these studies and future studies would help both the patients learn about the new and upcoming therapies, and help the clinical investigators to quickly screen their patients and invite them to participate in their studies.
The purpose of this study is to confirm the efficacy and safety of terlipressin in the treatment of adult subjects admitted to the hospital with hepatorenal syndrome (HRS) Type 1. Hepatorenal syndrome Type 1 is a severe, but potentially reversible, form of renal failure that afflicts patients with severe chronic liver disease associated with cirrhosis. This will be a randomized, placebo-controlled, and double-blinded multi-center study. Patients will be randomly be placed in either a terlipressin-treatment group or a placebo group. Neither you nor the study team will know which group you have been placed in. The study drug will be given as an IV injection every 6 hours while the patient is an inpatient at the hospital every 6 hours. This is a phase 3 study, with prior studies already showing promising results.
TARGET-HCC is a 5-year, longitudinal, observational study of the natural history and management of patients with HCC. The study will address important clinical questions that remain unanswered in the management of HCC with a unique research registry of participants with HCC from academic and community real-world practices. TARGET-HCC is disease focused, not drug specific, which allows for continuous acquisition of real-world evidence regarding the natural history, management, and outcomes of treatment with current therapies and new treatments that may be utilized in usual clinical practice.
This is a treatment study for people who have Nonalcoholic Steatohepatitis (NASH) fibrosis but not cirrhosis. The purpose of the study is to see whether the oral investigational medication, Elafibranor, is effective and safe in treating liver fibrosis.