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Cirrhosis clinical trials

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NCT ID: NCT05051293 Withdrawn - Cirrhosis Clinical Trials

Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension

Start date: August 22, 2021
Phase:
Study type: Observational

Cirrhosis is an end stage in liver disease leading to replacement of normal liver tissue with regenerative nodules surrounded by fibrous bands in response to chronic liver injury. It is the eighth leading cause of death in the United States and the thirteenth leading cause of death globally. Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension. The mechanism of hypotension in cirrhosis is thought to be a complex result of the presence of increased level of circulating vasodilators such a nitric oxide coupled with reduced resistance to vasoconstrictors and increased sensitivity to vasodilators.

NCT ID: NCT04048707 Withdrawn - Cirrhosis Clinical Trials

Angiotensin 2 for Hepatorenal Syndrome

ANTHEM
Start date: July 1, 2021
Phase: Phase 2
Study type: Interventional

Hepatorenal syndrome (HRS) is a disease in which patients with cirrhosis (end stage liver failure) develop secondary kidney injury and failure. The current treatment available in the United States is a combination of octreotide and midodrine, which are meant to decrease the release of those hormones and raise the blood pressure, respectively, which would increase blood flow to the kidneys. Angiotensin 2 (Ang2) is a new vasopressor drug that was approved by the FDA in December 2017 for patients with low blood pressure and has been shown to have similar effects to octreotide and midodrine. This study will investigate whether Ang2 reverses HRS among patients admitted to the intensive care unit (ICU) at Ronald Reagan Medical Center. Our study population will be patients with HRS who are already or will be admitted to the ICU. HRS will be defined by new internationally accepted guidelines published by the International Club of Ascites. All patients who are consented will undergo an Ang2 response trial, where low-dose Ang2 will be administered for 4 hours to see how the patients respond. This will help us characterize the nature of the patients' kidney failure for later analysis. Patients will then be randomized into the control group or the study group. Patients in the control group will receive octreotide (a subcutaneous injection) and midodrine (an oral drug). Patients in the study group will continue receiving intravenous infusion of Ang2. Patients in both groups will also receive albumin, a protein found commonly in human blood. Treatment will continue in both groups for four days, until complete reversal of HRS, dialysis, or death. Our primary outcome will be rate of reversal of HRS, defined as improvement in kidney function.

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: NCT03433508 Withdrawn - Cirrhosis Clinical Trials

Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock

Start date: December 15, 2018
Phase: N/A
Study type: Interventional

Consecutive cirrhotics who present to emergency department of ILBS with documented or suspected sepsis induced hypotension with Hb <8 gm/dl will be randomly assigned to restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1 proportion At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8 g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the discretion of clinicians.

NCT ID: NCT02837939 Withdrawn - Cirrhosis Clinical Trials

Transfer Factor Efficacy in the Management of Cirrhosis-associated Immune Dysfunction

IMUNO-HEGITO7
Start date: July 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs, chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections in acute or chronic decompensations of liver cirrhosis and acute on chronic liver failure..

NCT ID: NCT02824354 Withdrawn - Cirrhosis Clinical Trials

Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.

NalmeCir
Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption.

NCT ID: NCT02465619 Withdrawn - Cirrhosis Clinical Trials

To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis.

Start date: n/a
Phase: N/A
Study type: Observational

The study will be conducted on patients admitted to Department of Hepatology from MARCH 2015 to DECEMBER 2016 at ILBS, New Delhi.All patients presenting to ILBS fulfilling the inclusion criteria will be included in the study and will be categorized and evaluated. The patient will followed over a period of 3 months.

NCT ID: NCT02356250 Withdrawn - Cirrhosis Clinical Trials

A Pilot Study: Defining Peripheral Endothelial Function in Portal Hypertensive Cirrhotic Patients

Start date: February 18, 2015
Phase:
Study type: Observational

Rationale for the study: To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation between HVPG ( hepatic vein pressure gradient ) result and PEF result in a way that the result of the PEF test will be able to predict if a patient has CSPH (yes of no). By this, to try and develop a portable office-based device that can produce immediate results in a non-invasive manner in cirrhotic patients and help in evaluating prognosis in these patients in a noninvasive manner. Aim: The aim of this study is to try and characterize the peripheral endothelial function (PEF) in patient with cirrhosis and CSPH. This will be evaluated by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study.

NCT ID: NCT02275585 Withdrawn - Cirrhosis Clinical Trials

Portal Vein Thrombosis in Cirrhosis

Start date: October 2013
Phase: N/A
Study type: Observational

This study evaluates the supervivence of cirrhotic patients that develop portal vein thrombosis in comparison to cirrhotic patients that do not develop portal vein thrombosis.

NCT ID: NCT02258048 Withdrawn - Cirrhosis Clinical Trials

The Use of Transient Elastography to Predict Clinical Decompensation in Patients With Early Cirrhosis

Start date: October 2014
Phase: N/A
Study type: Observational

This is a prospective study designed to examine the role of transient elastography as a predictor of clinical decompensation in patients with early cirrhosis. The study objective is to determine if changes in measurements of liver stiffness with transient elastography can identify patients that will have a more rapid progression of cirrhosis and the development of clinical decompensation. The target population is patients with early stage, well-compensated cirrhosis. Participants of this study will be asked to complete the following procedures: read and sign the informed consent, medical records review (complete medical history, physical examination, laboratory evaluation, endoscopic findings, radiographic findings), undergo transient elastography to measure liver stiffness every three months until the development of clinical decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic encephalopathy) for up to 2 years.