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Hepatic Decompensation clinical trials

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NCT ID: NCT06449339 Not yet recruiting - Portal Hypertension Clinical Trials

Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease

BB_cACLD
Start date: July 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this randomised controlled trial is to evaluate the effect of carvedilol (a non-selective beta-blocker) in patients with compensated advanced chronic liver disease under clinically significant portal hypertension or the grey zone of Baveno VII criteria. The main question it aims to answer is: Does carvedilol reduce hepatic decompensation and mortality in these patients despite the absence of varices needing treatment. Researchers will compare carvedilol to no carvedilol to see if carvedilol can prevent hepatic decompensation and mortality. Participants will either take carvedilol or not taking carvedilol for 5 years with regular clinic visit for checkups and investigations, including blood tests, ultrasonography of the liver, upper gastrointestinal endoscopy, transient elastography.

NCT ID: NCT04460157 Recruiting - Clinical trials for Hepatocellular Carcinoma

Prediction of Liver-related Outcomes After HCV Cure

Start date: October 2011
Phase:
Study type: Observational [Patient Registry]

Objectives: To develop and validate a predictive model, applicable to daily practice, of liver complications emergence in hepatitis C virus (HCV)-infected patients and advanced fibrosis, who have achieved sustained viral response (SVR) with direct-acting antivirals (DAA)-based therapy. Methods: Design: Mulsite prospective multicenter cohort study. Study subjects: HCV-monoinfected and HIV/HCV-coinfected individuals recruited from two parallel cohorts (GEHEP-MONO Cohort clinicaltrials.gov ID: NCT02333292(HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003). These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Patients who fullfilled the following inclusion criteria are included in this study: 1) Have received a regimen with one or more DAA; 2) Have achieved SVR 12 weeks after treatment; 3) Have an evaluable liver stiffness (LS) of more than 9.5 kPa in the three months prior to the start of treatment. Follow-up: The baseline time point is the date of SVR. All participants are evaluated by a common protocol every six months. At every visit, clinical and laboratory examination focusing on the early detection of liver complications are carried out. LS is assessed by vibration-controlled transient elastography, according to a standardized procedure, every 12 months. In patients with cirrhosis, liver ultrasound and plasma alpha-fetoprotein determination are conducted for hepatocellular carcinoma screening, every six months. Variables and data analysis: The primary outcome variable of the study will be the emergence of liver complication (hepatic decompensation or hepatocellular carcinoma) or liver transplant. Predictive models will be develop with clinical, analytical, and genetic variables independently associated with the primary variable in a Cox regression for competitive risks applied to a developmental subpopulation. The performance of the model will be evaluated using COR curves. Sensitivity, specificity, and positive and negative predictive values will be calculated, both in the developmental population and in a validation population.

NCT ID: NCT01560845 Recruiting - Surgery Clinical Trials

ABMSC Infusion Through Hepatic Artery in Portal Hypertension Surgery for the Treatment of Liver Cirrhosis

Start date: June 2010
Phase: Phase 2/Phase 3
Study type: Interventional

In recent years, the safety and efficacy of autologous bone marrow stem cells infusion (ABMSCi) therapy were confirmed. The investigators attempted to infuse autologous bone marrow stem cells (ABMSC) through inserting a catheter into right gastric artery as far as proper hepatic artery after finishing open abdominal portal hypertension surgery. The present study was designed to treat bleeding from esophageal varices and hypersplenism and hopefully to improve the liver function as well.