Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
Hepatic EncephalopathyAscites2 moreThe purpose of this study is to determine the feasibility of a home meal delivery program for patients with cirrhosis and ascites and to determine the effectiveness of a salt-restricted (2 gram sodium) meal delivery program in reducing the need for therapeutic paracenteses and/or all-cause re-admissions for these patients. Many patients with cirrhosis don't have enough nutrients in the body and are frail and these meals may help them maintain a good diet and lead to improved quality of life.
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
Compensated CirrhosisNonalcoholic SteatohepatitisA multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.
Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
Liver CirrhosisPortal Vein ThrombosisThe study is aimed at evaluating the efficacy and safety of anticoagulant therapy with nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).
Combination of Autologous MSC and HSC Infusion in Patients With Decompensated Cirrhosis
CirrhosisLiverThough the results of autologous CD34+ cell infusion and MSC in independent studies have shown promise, yet they are yet to reach the desired long term outcome. The possible postulation for this is possibly because when using autologous CD34+ cell infusion, the inflammatory milieu of the liver may not be conducive for sustained effects of the mobilized CD 34+ cells. MSC have immunomodulatory effect (ref) and may improve the liver environment making it more beneficial for the CD34+ cells to function and survive. In addition, MSC has ben shown to produce hepatocyte growth factor which is protective against liver injury and beneficial for liver regeneration (shown in above tables). However, it remains to be understood how MSCs promote liver stem stem cells to differentiate into hepatocytes or expand the residual hepatocyte population. MSC can also directly inhibit the activation of hepatic stellate cells, the main source of extracellular matrix via MSC derived IL 10 and TNF-αand may also induce hepatic stellate cell apoptosis. Current lacunae in cell based therapy is based on the poor consensus and understanding on the best type of cells to be used, the ideal number of cells, the most appropriate route of administration and the need for repeat dosing . The concept that combination of autologous hematopoietic and mesenchymal stem cells infusion may be more beneficial than infusing any one of them alone has been discussed in many scientific forums but there are no study till date to either see the safety as well as the efficacy of this proof of concept . With this above background data, we propose a study design which will be a safety study for combination use of autologous CD34+ and MSC
HMB for Denutrition in Patients With Cirrhosis (HEPATIC)
SarcopeniaCirrhosis1 moreCirrhosis is a late stage of hepatic fibrosis caused by many forms of liver diseases and conditions, such as hepatitis and chronic alcoholism. The World Health Organization (WHO) has reported that this condition accounts for 1.8% of all deaths in Europe (170,000 deaths/year). Patients with cirrhosis are characterized by severe metabolic alterations, which converge in a malnutritional state. Malnutrition encompasses glucose intolerance, chronic inflammation, altered gut microbiota, reduced muscle mass (sarcopenia), as well as loss and dysregulation of adipose tissue (adipopenia). Malnutrition is the most frequent complication that adversely affects the outcomes of cirrhotic patients. Yet, despite its clinical repercussions and potential reversibility, there are no effective therapies because our limited understanding of the mechanisms underlying this altered metabolism. β-hydroxy β-methylbutyrate (HMB) is a naturally produced substance regarded as safe and effective in preventing muscle loss during chronic diseases. Previous studies have indicated some beneficial effects of HMB itself or its parent metabolite, leucine, on adipose tissue, glucose intolerance, inflammation, and gut microbiota. This study aims to translate those beneficial effects to cirrhotic patients. The investigators hypothesize that HMB can improve cirrhosis-related metabolic abnormalities through its pleiotropic effects. The goals of this study are: i) to perform a randomized clinical trial to evaluate the efficacy of HMB, administered as nutritional supplementation, on clinical symptoms of cirrhosis. ii) to uncover the precise metabolic pathways that underlie HMB action, with a special focus on muscle, adipose tissue, and gut microbiota.
Empagliflozin in Diuretic Refractory Ascites
Liver CirrhosisCirrhosis3 moreAscites is the most frequent complication of liver cirrhosis and results in increased morbidity and mortality but current medical management options are limited. Here, the investigators will conduct an interventional single-arm pilot clinical trial toevaluate the feasibility of empagliflozin in managing diuretic-resistant ascites in patients with decompensated cirrhosis. This single site, open label pilot study will enroll participants with decompensated cirrhosis at a single site. Participants will receive empagliflozin 10mg oral tablets once daily for 12 weeks with monitoring for safety and adverse events.
Composition for Treating Cirrhosis and Liver Cancer (SB-1121)
Cirrhosis of the LiverThe composition treats cirrhosis and hepatocellular carcinoma (Hcc) at an early stage. The product is extracted from herbs, including Adenosma glutinosum extract, Eclipta prostrata extract, Phyllanthus urinaria extract, Impatiens balsamina extract, Ascorbic acid, pyridoxine 5-phosphate, L-Arginine hydrochloride, Pregnenolone acetate. These components have participated in repairing and regenerating new liver parenchyma, preventing fibrosis cell generation, preventing liver cancer cell growth at an early stage. The composition supplements precursors which help the body strengthen antibodies and reduce the risk of inflammation, restore physiological and biochemical functions of liver cells after chronic inflammation.
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
NASH - Nonalcoholic SteatohepatitisFibrosis2 moreThis is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
Albumin Infusion in Inpatients With Decompensated Cirrhosis
Decompensated CirrhosisAcute-On-Chronic Liver FailureAlbumin infusion in patients with hospitalized decompensated, even in short-term period use, could improve survival through the reduction of systemic inflammation, which is the main driver of acute-on-chronic liver failure in cirrhosis. The effects could be highly associated with the albumin dosage. A comprehensive evaluation of the inflammation response by robust measurement is needed to prove insights into the therapeutic implications of albumin infusion. The purpose of this study is to compare the effects of different amount of human albumin infusion per week in patients with hospitalized decompensated cirrhosis on 28-day transplant-free survival and to further compare the alleviation of inflammation, reduction of incidence of nosocomial infection, spontaneous bacterial peritonitis (SBP), acute kidney injury (AKI), acute-on-chronic liver failure (ACLF), and 90-day transplant-free survival. This will be a multicenter, national, retrospective study. There will be no randomization in this retrospective study. All patients who meet the inclusion criteria and not the exclusion criteria will be enrolled. All identified patients who meet criteria will be given an ID number comprised of a site number and patient number.
Liver Fibrosis and Steatosis in dm Non Invasive Evaluation
Liver DiseasesNon invasive evaluation of liver fibrosis and steatosis in type 2 diabetic patient in Assiut University hospitals