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Liver Cirrhosis clinical trials

View clinical trials related to Liver Cirrhosis.

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NCT ID: NCT06312826 Recruiting - Clinical trials for Hepatocellular Carcinoma

Abbreviated MRI Using Gadoxetic Acid Versus Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk

Start date: August 26, 2022
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma (HCC) is the third most frequent cause of cancer-related deaths worldwide. The incidence of HCC has been rapidly rising worldwide over the last two decades. In order to improve survival with curative treatment, regular surveillance to detect early-stage HCC is recommended for at-risk populations. Although ultrasonography (US) has been endorsed as the primary surveillance tool for HCC, a recent meta-analysis found that US has a sensitivity of 47% for detecting early-stage HCC, and its sensitivity for detecting early-stage HCC has been questioned. Many recent studies have explored the potential of alternative surveillance tools for HCC other than US, particularly for high-risk patients. Although complete gadoxetic acid-enhanced magnetic resonance imaging (MRI) demonstrated excellent performance, its high cost and long examination time can hamper its widespread adoption. Abbreviated MRI (AMRI) including hepatobiliary-phase imaging is a promising option to detect potential indicators of HCC, maintaining the benefits of highly sensitive imaging while reducing the examination time by omitting dynamic contrast-enhanced imaging. Because US is the current primary surveillance tool for HCC, this new surveillance tool must be compared with US in a prospective randomized comparative design. Thus, the hypothesis to be proved in this study is as follows: AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC, defined as an estimated annual HCC risk of higher than 5%. We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate.

NCT ID: NCT06308757 Recruiting - Obesity Clinical Trials

Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis

KETONASH
Start date: September 29, 2021
Phase: N/A
Study type: Interventional

The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD).

NCT ID: NCT06306781 Not yet recruiting - Clinical trials for Decompensated Cirrhosis

A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis

Start date: March 30, 2024
Phase: N/A
Study type: Interventional

This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis.

NCT ID: NCT06296095 Enrolling by invitation - Cirrhosis, Liver Clinical Trials

To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis

Start date: August 9, 2023
Phase: Phase 1
Study type: Interventional

The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis

NCT ID: NCT06293378 Recruiting - Cirrhosis, Liver Clinical Trials

Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, changes in fecal flora and metabolites before and after the use of sulfasalazine were observed.

NCT ID: NCT06288828 Not yet recruiting - Physical Activity Clinical Trials

The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients With Compensated Cirrhosis

Start date: March 5, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to explore the impact of a 16-week aerobic exercise regimen on the autonomic nervous system and endothelial function in patients with compensated cirrhosis who maintain sedentary lifestyles. The primary research question is: 1) What effect does 16 weeks of aerobic exercise have on changes in the autonomic nervous system and endothelial function in cirrhotic patients? Additionally, the secondary research questions are: 1. How does a 16-week aerobic exercise program influence changes in muscle mass, muscle strength, and physical performance in cirrhotic patients? 2. Is there a correlation between muscle mass and parameters of the autonomic nervous system in cirrhotic patients? Participants in the intervention group will undergo 150 minutes of moderate aerobic exercise per week for 16 weeks, accompanied by a personalized nutritional plan (1.2 grams of protein per kilogram of ideal body weight per day and a calorie intake of 35 kilocalories per kilogram of ideal body weight per day). The control group will solely receive nutritional guidance and maintain their sedentary lifestyle. The researchers will compare outcomes between these two groups.

NCT ID: NCT06279845 Not yet recruiting - Liver Cirrhosis Clinical Trials

A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection

Start date: March 2024
Phase:
Study type: Observational

The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. The main questions it aims to answer are: - Describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis. - Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression.

NCT ID: NCT06277882 Recruiting - Cirrhosis Clinical Trials

Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis

Start date: February 29, 2024
Phase: Phase 4
Study type: Interventional

The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications. However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general population HAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population. The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis. The main questions it aims to answer are: - Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis. - Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.

NCT ID: NCT06269484 Recruiting - Liver Cirrhosis Clinical Trials

A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK

ZEAL UNLOCK
Start date: February 15, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase IIb multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the safety of zibotentan/dapagliflozin in combination as compared to zibotentan monotherapy as well as zibotentan/dapagliflozin and zibotentan monotherapy as compared to placebo in patients with cirrhosis.

NCT ID: NCT06267794 Completed - Cirrhosis, Liver Clinical Trials

Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis.

ODISEA
Start date: June 26, 2015
Phase: Phase 2
Study type: Interventional

This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov.