38 Clinical Trials for Various Conditions
This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.
Liver Cirrhosis Network (LCN) Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months (180 days), with opportunities to complete specific visit components via telehealth or remotely. Visits will include collection of questionnaire data and the in-person visits will include questionnaires, physical exams, imaging, and sample collection.
Background: * Liver cancer is the third most deadly and fifth most common cancer worldwide. Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has grown more prevalent in the United States. * More information is needed about the causes and effects of liver cancer, and further research into individuals who are at high risk for developing liver cancer is needed for early diagnosis and prevention. Objectives: * To identify genetic factors that may help to explain the aggressiveness of liver cancer. * To determine if HCC biomarkers exist in blood, urine, and tissue samples. Eligibility: * Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high risk for developing HCC because of fatty liver disease (alcohol-related or non-alcohol-related) or chronic hepatitis B or C. * Participants will reside in Baltimore City and the surrounding areas. Design: * Participants will complete a questionnaire and provide blood and urine samples for testing: * The questionnaire will include questions about individual and family medical history, tobacco use, and exposure to known factors for liver cancer. * Blood and urine samples will be collected from all participants after the questionnaire. * Tumor tissue and healthy tissue will be collected from selected participants if they undergo surgery for their cancer or disease. * No specific treatment will be offered as part of this protocol, but participants have the option to be treated under different protocols.
This is a multi-center, prospective, randomized trial of standard of care vs. standard of care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic hepatitis and DF≥32.
The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.
The purpose of this study is to determine if zinc therapy: (1) strengthens your intestine's defensive barrier preventing damaging substances from reaching your liver, (2) decreases liver injury (inflammation, oxidative stress, cell death) and scarring, and (3) improves your liver-related health. Based on our preliminary animal data and other published reports, we expect zinc therapy to achieve all of these goals. Zinc is affordable, available over the counter or by prescription, and has an excellent safety profile. Positive results from this study will show that zinc is a significant therapy for millions of Americans with alcoholic liver disease.
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. The study will evaluate if mild hypothermia protects from AKI during liver transplantation.
The purpose of this study is to determine the amount of fibrosis in the liver of hepatitis C patients with advanced fibrosis, using endoscopic ultrasound.
This study is to evaluate the safety and efficacy of a single dose of Cellgram™ delivered via hepatic artery in patients with decompensated alcoholic liver cirrhosis.
A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. Subjects must have been enrolled in a prior IDN-6556 study to be eligible.
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: * Randomized Double-Blind Phase * Open-Label Phase (optional)
This study is open to adults with liver cirrhosis caused by hepatitis B, hepatitis C or nonalcoholic steatohepatitis (NASH). People can join this study if they have high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) taken alone or in combination with a medicine called empagliflozin helps people with this condition. Participants take Avenciguat (BI 685509) as tablets twice a day for 8 weeks. Half of the participants with NASH who also have type 2 diabetes take empagliflozin as tablets once a day in addition to Avenciguat (BI 685509). Participants are in the study for about 3 months. During this time, they visit the study site about 10 times. At 2 of the visits, the doctors check the pressure in a liver vein to see whether the treatment works. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The doctors also regularly check participants' health and take note of any unwanted effects.
Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn: * If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver * About the safety of efinopegdutide and how well people tolerate it
A double-blind placebo controlled randomized Phase 3 study to evaluate the safety and tolerability of once-daily, oral administration of 80 or 100 mg resmetirom versus matching placebo. At least 100 patients will be enrolled in a 100 mg open-label arm and will include a special safety population (eg, patients with compensated NASH cirrhosis).
This study will evaluate the effect of probiotics, a beneficial intestinal bacteria supplement, if it will cause improvement of the non-alcoholic fatty liver disease (NAFLD) and or non-alcoholic steatohepatitis (NASH- an inflammation with concurrent fatty accumulation of the liver) as measured by transient elastography - an ultrasound of the liver that assess the elastic properties (density) and stiffness of the liver tissue. This study will enroll patients 18 years and older with diagnosis of NAFLD and or NASH.
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis. This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new decompensation events, and MELD score progression are events) in subjects with decompensated NASH cirrhosis.
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
1. Further characterize the incidence of hyperfibrinolysis in cirrhotics 2. Correlate hyperfibrinolysis with 1. hepatitis C 2. alcoholic liver disease 3. the subset of a\&b with renal failure with and without dialysis 3. Better describe the hyperfibrinolytic ROTEM profile in cirrhotics
Background: - Non-alcoholic fatty liver disease is the most common form of liver disease in the United States. It includes many conditions. Researchers want to study fatty liver disease by looking at people who have liver cirrhosis. They also want to look at people who are or were listed for liver transplants. Genetic studies may provide more information on the causes of these conditions. Objectives: - To study possible genetic causes of non-alcoholic fatty liver disease. Eligibility: - Individuals of any age who have non-alcoholic fatty liver disease and related conditions. Design: * Participants will be screened with a physical exam and medical history. * Participants will provide a blood sample for genetic testing. Liver tissue from a transplant or biopsy may also be studied. * Participants may also be asked to have an imaging study of the liver. This imaging study may be an x-ray or magnetic resonance imaging. * No treatment will be provided as part of this research study.
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.
To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after 24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.
Non-alcoholic fatty liver disease (NAFLD) is a common disorder, affecting \~30% of people in the general population and up to 96% of obese individuals. Variations in several genes have been found to be associated with fatty liver, but these associations only explain a small percentage of the risk, and further studies are needed. In many cases NAFLD does not cause serious side effects, but in some individuals it progresses to scarring or hardening of the liver, liver failure, and cancer. The purpose of this research study is to determine if individuals who carry certain genetic variations in a gene related to bile and choline metabolism have an increased risk of fatty liver progressing to fibrosis, or scarring of the liver. This study will also use a new, non-invasive method called the FibroScan® to measure liver fat and liver stiffness. The FibroScan® device is FDA approved for use to measure liver stiffness, but not for the liver fat measurement. However, the FibroScan® instrument is considered a non-significant risk device. Since its induction in Europe and worldwide in 2003, there have been no adverse effects reported with this device.
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2. To determine the critical value of hepatic metabolic function as measured by BreathID will predict which patients are at risk to develop complications of cirrhosis. 3. To determine the critical value of hepatic metabolic function as measured by BreathID will predict which patients are at risk for liver related mortality. The hypothesis is that the BreathID breath test will correlate to CTP and MELD scores, and that thresholds can be established that will help predict risk of complications of cirrhosis and mortality.
This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.
This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 \[NCT02217475\] or the AURORA study \[NCT03028740\].
The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The intervention includes comprehensive, standardized palliative care services for adult hepatology cirrhosis patients for which prognosis is poor.