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Liver Failure clinical trials

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NCT ID: NCT03908255 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma

BCAA in HCC
Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

Hepatocellular carcinoma (HCC) is the fifth most common cause of cancer death among men. While several new treatment options have recently become available, they are costly and have a potential for significant, adverse side effects. Many patients diagnosed with HCC also suffer from underlying liver disease, including cirrhosis. As many as 80-90% of patients diagnosed with HCC also have cirrhosis. Protein-energy malnutrition (PEM) in cirrhosis is as high as 65-90% and significantly increases the risk of morbidity and mortality as well as decreased quality of life. Branched-chain amino acid (BCAA) supplementation has been extensively studied for usefulness in liver disease, specifically to treat hepatic encephalopathy to and preserve and restore muscle mass. Maintenance of liver function and prevention of PEM are essential for improving outcomes in patients with HCC. Branched-chain amino acid supplementation in HCC has been studied extensively in China & Japan with multiple studies showing improvements in liver function, progression-free survival, and overall survival. Additionally, patients in treatment groups have shown improvement in quality of life indicators. However, these results have yet to be replicated in the United States. Branched-chain amino acid supplementation may be a safe, low-cost approach to improve survival, liver function indicators, and quality of life for patients diagnosed with HCC. In this study, patients with primary HCC will be randomized to either a treatment group, which will receive standard of care and BCAA supplement or to a control group which will receive standard of care and a maltodextrin placebo. Both groups will receive liver-directed therapy including transarterial chemoembolization (TACE) and thermal ablation. All patients will complete a quality of life survey (FACT-Hep) at each visit.

NCT ID: NCT03882346 Recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients

Start date: March 29, 2019
Phase: Phase 2
Study type: Interventional

This is a prospective, comparative, open label, phase 2b study designed to investigate the safety and efficacy of LifeLiver (an Extracorporeal Bio Artificial Liver). The study will recruit approximately 40 acute or acute-on-chronic liver failure patients.

NCT ID: NCT03878329 Completed - Clinical trials for Liver Transplant; Complications

Telemedicine Based Remote Home Monitoring After Liver Transplantation

TelehealthOLT
Start date: January 1, 2017
Phase: N/A
Study type: Interventional

A significant opportunity exists to involve patients and their caregivers in more effective perioperative care and transition to home for transplant patients. Stakeholders were engaged through the University of Cincinnati Liver Transplant Program to prioritize changes in improving post transplant care. The initial findings indicated that increasing "care between visits" is the top priority for patients for improving function, quality of life and independence. Building on existing telehealth research, an enhanced home management program (HMP) to leverage and improve patient self-care following liver transplantation was developed, specifically by improving adherence, reducing readmissions and improving the transition from hospital to home. The improvement of care may have profound effect in the first 90 days after transplant on important long-term health parameters that affect clinical outcomes such as depression, weight gain, blood pressure control and diabetes management. With patient engagement, a randomized controlled trial is proposed comparing traditional provider-based care vs. traditional care with HMP. These two arms will need 50 patients in each arm with a 0.5 year follow up. Patients have said that the primary outcomes are quality of life, function and independence. To that end, the primary study outcomes are assessment of adherence, readmissions (90-day), patient satisfaction. The HMP model will advise providers, health care systems, and transplant centers how to improve patient care, especially among those at greatest risk of poor outcomes specifically minorities and those of low socioeconomic status.

NCT ID: NCT03864497 Completed - Liver Failure Clinical Trials

Myocardial Perfusion Imaging in Liver Transplantation Candidates

ExSPECT
Start date: September 2007
Phase:
Study type: Observational

The optimal screening strategy for assessment of coronary artery disease in patients with end-stage liver disease (ESLD) is unclear. Although consensus based guidelines support noninvasive stress testing prior to orthotopic liver transplantation (OLT), no prospective studies are available to inform the clinician on perioperative risk stratification. This observational cohort study was designed to determine the prognostic utility of single photon emission computed tomography (SPECT) imaging in OLT candidates.

NCT ID: NCT03863002 Not yet recruiting - Clinical trials for Liver Failure, Acute on Chronic

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

Start date: October 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

NCT ID: NCT03860155 Terminated - Clinical trials for Acute-On-Chronic Liver Failure

Allogeneic ABCB5-positive Stem Cells for Treatment of Acute-on-Chronic Liver Failure

Start date: March 22, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is an interventional, single arm, multicenter, phase I/IIa clinical trial. The study objective is to investigate the efficacy and safety of three i.v. doses of the investigational medicinal product (IMP) allo-APZ2-ACLF for the treatment of acute-on-chronic liver failure (ACLF). The allogeneic IMP allo-APZ2-ACLF contains skin-derived ABCB5-positive mesenchymal stem cells isolated from skin tissue of healthy donors and stored in a donor cell bank.

NCT ID: NCT03842761 Completed - Healthy Clinical Trials

A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems

Start date: March 6, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment [Child-Turcotte-Pugh (CTP) classification A and B] over different dose regimes of BI 685509 compared to placebo. A secondary objective is to investigate pharmacokinetics of different doses of BI 685509 in patients with mild to moderate hepatic impairment (CTP A and CTP B). In addition, another secondary objective is to compare safety, tolerability, and pharmacokinetics in patients with mild to moderate hepatic impairment (CTP A and CTP B) of single BI 685509 dose to individually matched healthy volunteers

NCT ID: NCT03833297 Completed - Liver Diseases Clinical Trials

Monitoring the HePAtological TOXicity of Drugs (HePATOX)

HePATOX
Start date: February 4, 2019
Phase:
Study type: Observational

Several drugs and chemotherapies seem to have an impact on the hepatological system. This study investigates reports of hepatological toxicities, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

NCT ID: NCT03791190 Recruiting - Liver Failure Clinical Trials

RCA for CRRT in Liver Failure and High Risk Bleeding Patients

Start date: September 6, 2018
Phase: N/A
Study type: Interventional

The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in patients with liver failure and high risk bleeding.

NCT ID: NCT03773887 Recruiting - Liver Diseases Clinical Trials

Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

TargetOH
Start date: September 2015
Phase: N/A
Study type: Interventional

The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease