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Liver Disease clinical trials at University of California Health

33 in progress, 24 open to eligible people

Showing trials for
  • A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).

    open to all eligible people

    This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].

    at UCSF

  • Alcoholic Liver Disease and the Gut Microbiome

    open to eligible people ages 18 years and up

    Background: Significant sex differences exist in regard to alcohol use disorder (AUD) and alcoholic liver disease (ALD). To date, no studies have examined the brain-gut-microbiome (BGM) axis (which is the relationship between the gut, brain, and the bacteria within the gut) and sex-differences in AUD and ALD. Aims: 1) Demonstrate baseline sex differences in the microbiome and metatranscriptome of AUD and ALD and correlate those differences to severity, 2) determine if these baseline sex differences predicts abstinence or ALD related outcomes, and 3) show how altering the microbiome can decrease the severity of AUD and ALD in a sexdependent manner. Hypothesis: Our project is aimed to explore the hypothesis that sex-related differences of the BGM axis in AUD and ALD explains the variation in patient severity and outcome by sex, and that alterations of the BGM axis can decrease the severity of AUD and ALD in a sex-dependent manner. Methods: A pilot randomized placebo (VSL#3 vs placebo) control trial will be performed in patients with AUD and ALD for 6 months. Questionnaire data, clinical labs, serum, and feces for shotgun metagenomics will be collected at baseline, 3-months, and 6-months. Anticipated Results: Patients with severe AUD/ALD will have more microbes and microbial genes associated with inflammation. These differences will predict outcomes at 6-months and that changes of this baseline microbiome with VSL#3 will lead to more positive outcomes than placebo, with men having greater benefit from VSL#3 than women. Implications and Future Studies: The discovery of the mechanisms underlying sex-related differences in AUD/ALD is needed for the development of personalized recommendations for prevention and treatment in men and women

    at UCLA

  • Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation

    open to eligible people ages 18 years and up

    This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver transplantation with ex-vivo liver preservation using static cold storage (SCS) followed by hypothermic oxygenated machine perfusion (HOPE) versus SCS only.

    at UCSF

  • Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use

    open to eligible people ages 18 years and up

    The study consists of a randomized controlled trial evaluating the efficacy and feasibility of a stepped alcohol treatment using telemedicine on unhealthy alcohol use in patients with chronic liver disease receiving care in hepatology practices at three sites. Patients who meet eligibility criteria will be randomized to one of two study arms: 1) Stepped Alcohol Treatment (SAT) or, 2) Usual Care (UC). Participants will be randomized separately by site. SAT includes 3 sessions of motivational interviewing followed by referral to addiction medicine for patients who do not reduce unhealthy drinking. Trial outcome measures will be complete at 6 and 12 months following baseline enrollment.

    at UCSF

  • Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease

    open to eligible people ages 21 years and up

    This is a phase I study of guselkumab, a humanized anti-IL23 monoclonal antibody, for patients with alcoholic liver disease. This drug is approved for the use in psoriatic arthritis but not for alcoholic liver disease. The investigators will be using a standard 3+3 phase I dose escalation trial design, the dose levels will start from 30 mg, 70 mg and to 100 mg, a maximum total of 24 patients will be evaluable. In this study the investigators propose to establish safety of the product in those with alcoholic liver disease and efficacy (secondary endpoint) will be determined by biomarkers for liver inflammation and fibrosis surrogate biomarkers.

    at UCSD

  • Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)

    open to eligible people ages 18-120

    This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are: Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), Model 2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal training to deliver Palliative Care services) Primary Outcome: The change in quality of life from baseline to 3 months post enrollment as assessed by FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary). 14 Clinical Centers across US are recruited to participate in this study.

    at UCSF

  • Mild Hypothermia and Acute Kidney Injury in Liver Transplantation

    open to eligible people ages 18 years and up

    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.

    at UCSF

  • Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

    open to eligible people ages 21-75

    The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

    at UCSD

  • Saroglitazar Magnesium 4 mg in the Treatment of NAFLD in Women With PCOS (EVIDENCES VII)

    open to eligible females ages 18-45

    This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.

    at UCSF

  • Treating Pediatric NAFLD With Nutrition

    open to eligible people ages 10-17

    This is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD.

    at UCSD

  • Vitamin E Dosing Study

    open to eligible people ages 18 years and up

    This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).

    at UCSD UCSF

  • A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH)

    open to eligible people ages 2 years and up

    TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice. TARGET-NASH is a research registry of patients with NAFL or NASH within academic and community real-world practices maintained in order to assess the safety and effectiveness of current and future therapies.

    at UC Davis

  • An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection

    open to eligible people ages 18 years and up

    The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The current protocol (Amendment 1) describes the second phase of the study that will engage research activities for patients being managed for CHB in usual clinical practice in the US and Canada. The study addresses important clinical questions regarding the management of CHB by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to antiviral treatments used in clinical practice.

    at UC Davis

  • Development of Kinetic Biomarkers of Liver Fibrosis Measuring NAFLD

    open to eligible people ages 18 years and up

    This is a small preliminary study conducted to explore new methods for the potential of aiding in diagnosis of liver fibrotic disease as well as predicting disease progression. There will be a total of 4 visits spread out over approximately 8 weeks. You will be asked to drink "heavy water" during most of that time. "Heavy Water" also known as deuterated water, is physically and chemically very similar to ordinary drinking water. It tastes and feels exactly like regular water. It is odorless and has no known harmful effects at the doses given here. Heavy water occurs naturally, and is a minor component of the water we all ingest daily.

    at UCSD

  • Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation

    open to eligible people ages 18 years and up

    INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study.

    at UCSF

  • Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER

    open to eligible people ages 18 years and up

    Evaluation of Multi-Organ Metabolism and Perfusion in Non-Alcoholic Fatty Liver Disease (NAFLD) by Total Body Dynamic PET Scan on EXPLORER

    at UC Davis

  • Functional Assessment in Liver Transplantation

    open to eligible people ages 18 years and up

    This will be a prospective cohort study of patients with liver disease. Subjects will undergo geriatric assessments of frailty, functional status, and disability using functional status measures at baseline and at every clinic visit in the pre-transplant setting. Subjects will also answer questions regarding quality of life, personality, and/or cognitive function. Subjects will again undergo assessments at every clinic visit through 12 months after transplant. Then, they will be followed annually.

    at UCSF

  • Heritability of Fatty Liver as Measured by MRI: a Cross Sectional Study of Twins and Family Members

    open to eligible people ages 18-100

    Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the United States. The cause of NAFLD is poorly defined but is thought to involve complex interactions of genetic and environmental factors. NAFLD is often associated with the traits of the metabolic syndrome including diabetes, high cholesterol or elevated blood pressure. Currently, there are no accurate noninvasive means of evaluating NAFLD and its more serious form which includes inflammation that may lead to severe scarring in the liver. The goal of this study is to evaluate shared genetic factors that underlie NAFLD and features of the metabolic syndrome as determined by blood work and radiographic studies in a cohort of twins and first degree relatives.

    at UCSD

  • Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis

    “Comparison of imaging techniques used to evaluate patients with liver disease”

    open to eligible people ages 18 years and up

    The goal of this study is to evaluate non-invasive imaging techniques for determining liver steatosis (fat), inflammation (abnormal tissue swelling), and fibrosis (abnormal tissue scarring).In addition, the study group will be using other test measures including personal demographics, laboratory blood test results, and imaging measurements to determine the severity of NAFLD (non-alcoholic fatty liver disease), NASH (non-alcoholic steatohepatitis), inflammation, and fibrosis.

    at UC Davis

  • Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

    open to eligible people ages 2 years and up

    The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients suspected or known to have NAFLD or NASH-related cirrhosis. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.

    at UCSD UCSF

  • Nonalcoholic Fatty Liver Disease in HIV Database

    open to eligible people ages 18 years and up

    Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. The spectrum of NAFLD encompasses simple nonalcoholic steatosis (nonalcoholic fatty liver [NAFL]) and nonalcoholic steatohepatitis (NASH) in which there is evidence of hepatocellular injury and/or fibrosis. NAFLD is the most common liver disease in adults and the second leading cause for liver transplantation in the U.S. The natural history of NAFLD in the general population has been well described. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002 to further the understanding of the diagnosis, mechanisms, progression and therapies of NASH. This effort has resulted in numerous seminal studies in the field. However, NASH CRN studies have systematically excluded persons living with HIV (PLWH) , as NAFLD in PLWH was thought to be different from that in the general population due to HIV infection, antiretroviral therapy (ART), concomitant medications and co-infections. This resulted in major knowledge gaps regarding NAFLD in the setting of HIV infection. Thus, the natural history of NAFLD in PLWH is largely unknown. The goal of this ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), is to conduct a prospective, observational, multicenter study of biopsy-proven NAFLD in PLWH (HIV-associated NAFLD).

    at UCSD UCSF

  • Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition

    open to eligible people ages 12-80

    This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week. Liver disease will be determined by the presence of choline deficiency, cholestasis (confirmed by elevated serum alkaline phosphatase (ALP) liver isoenzyme level), and steatosis (confirmed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF). The objective of this study is to investigate the presence/prevalence of liver disease in patients dependent on PN (≥4 days a week).

    at UCLA

  • Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE

    open to eligible people ages 1 month to 17 years

    Magnetic resonance imaging (MRI) is used to measure liver fat content and fatty tissues in the body, and magnetic resonance elastography (MRE) is used to measure liver stiffness. The information from MRI and MRE are used to understand risk factors and diagnose liver diseases, such as fatty liver disease and liver fibrosis. However, current MRI and MRE scans need to be performed during a breath-hold, which may be challenging or impossible in children and infants. The goal of this research project is to develop and evaluate new free-breathing MRI and MRE technology to improve the comfort and diagnostic accuracy for children and infants.

    at UCLA

  • Social & Contextual Impact on Children Undergoing Liver Transplantation

    open to eligible people ages up to 70 years

    The social determinants of health have a large impact on health. For example, neighborhood socioeconomic deprivation is associated with increased risk of medication non-adherence, graft failure, and death in children after liver transplant. In order to address these socioeconomic inequities in outcomes, a more granular understanding of how the social determinants of health impact outcomes is needed. In this observational prospective cohort, caregivers of children undergoing liver transplantation will complete surveys and undergo in-depth, qualitative interviews. The survey will assess comprehensively for the social determinants of health (e.g. material economic hardship, health literacy, social connectedness, primary care quality, etc). The qualitative interviews will identify barriers and facilitators that socioeconomically deprived children/families have to obtaining the ideal outcome and identify health system opportunities to integrate social needs and medical care. Data will be linked to an existing prospective cohort study (The Society for Pediatric Liver Transplant registry) to assess the impact of social risk on outcomes after transplant. Healthcare providers who take care of children undergoing liver transplant will also be included in the qualitative interviews. The goal of including this group in the study is to determine the health systems barriers and facilitators to social needs screening and intervention.

    at UCSF

  • Angiotensin 2 for AKI After OLT

    Sorry, accepting new patients by invitation only

    Kidney injury is a common complication following liver transplantation and is associated with a higher complication rate and increased risk of death. While there are many factors that likely contribute to kidney injury in the perioperative period, a relative low serum level of angiotensin 2 (Ang 2) (a protein hormone that causes blood vessels to narrow) found in patients with liver cirrhosis (late stage of liver damage) may increase their risk of developing acute kidney injury (sudden episode of kidney failure or damage). We propose to investigate how early administration of Ang 2, a new vasopressor drug approved by the FDA in December 2017 for patients with low blood pressure, during the intra-operative period of liver transplant surgery affects the rate of kidney injury after transplantation. Patients who are deemed appropriate candidates for the study will be randomized 1:1 to the treatment and control groups. The intervention period of the study will occur in the operating room during transplant surgery and will be performed by their anesthesiologists. In the Treatment group, patients will receive Ang 2 infusions in addition to other standard vasopressors while patients in the control group will receive standard vasopressors alone. The infusion of Ang 2 in the treatment group will continue through the duration of the surgery and will be stopped prior to leaving the operating room. Both the treatment group and the control group will then be followed for 14 days to evaluate rates of kidney injury and to look for any complications. The follow up period will be extended to 28 days to look at in-hospital mortality rates in both groups. The daily follow up analysis will occur while the enrolled patients are inpatient following their transplantation surgery and will be done by looking at lab values and other data that is routinely gathered by their managing teams. This study will serve as a pilot study to evaluate feasibility of our protocol and to collect some preliminary data on the use of Ang 2 in this patient population. As such we plan to enroll approximately 30 patients who have accepted an offer to receive a donor liver. We hope to reach our goal enrollment within 5 months of starting the study.

    at UCLA

  • Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)

    Sorry, in progress, not accepting new patients

    The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).

    at UCSD

  • Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)

    Sorry, in progress, not accepting new patients

    This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH). Subjects will be randomly assigned toTVB-2640 or matching placebo PO QD for 52 weeks, with the first dose administered on Day 1.

    at UCSD

  • A Prospective Database of Infants With Cholestasis

    Sorry, not currently recruiting here

    Biliary atresia, idiopathic neonatal hepatitis, and specific genetic cholestatic conditions are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Childhood Liver Disease Research Network (ChiLDReN) is to establish a database of clinical information and plasma, serum, and tissue samples from cholestatic children to facilitate research and to perform clinical, epidemiological and therapeutic trials in these important pediatric liver diseases.

    at UCSF

  • FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

    Sorry, in progress, not accepting new patients

    Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and quantify liver fibrosis.

    at UCSF

  • Genetic Collection Protocol

    Sorry, not currently recruiting here

    This study involves the one-time collection of whole blood or saliva samples for the extraction and storage of DNA for use in ongoing and future ChiLDReN studies.

    at UCSF

  • Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)

    Sorry, not currently recruiting here

    Cholestasis is a condition in which bile is not properly transported from the liver to the small intestine. Cholestasis can be caused by an array of childhood diseases, including the genetic diseases Alagille syndrome (ALGS), alpha-1 antitrypsin (a-1AT) deficiency, bile acid synthesis and metabolism defects, and progressive familial intrahepatic cholestasis (PFIC) or benign recurrent intrahepatic cholestasis(BRIC). This study will investigate the natural history and progression of the four previously mentioned cholestatic liver diseases to provide a better understanding of the causes and effects of the diseases.

    at UCSF

  • Longitudinal Study of Mitochondrial Hepatopathies

    Sorry, not currently recruiting here

    The specific aims of this study are (1) to determine the clinical phenotypes and natural history of hepatic RC and FAO disorders, (2) to determine the correlation between genotype and phenotype, (3) to determine if circulating biomarkers reflect diagnosis and predict liver disease progression and survival with the native liver, (4) to determine the clinical outcome of these disorders following liver transplantation, and (5) to develop a repository of serum, plasma, urine, tissue and DNA specimens that will be used in ancillary studies. To accomplish these aims, the ChiLDREN investigators at clinical sites (currently 15 sites) will prospectively collect defined data and specimens in a uniform fashion at fixed intervals in a relatively large number of subjects. Clinical information and DNA samples to be collected from subjects and their parents will enhance the potential for meaningful research in these disorders. A biobank of subject specimens and DNA samples will be established for use in ancillary studies to be performed in addition to this study.

    at UCSF

  • Technical Validation of MR Biomarkers of Obesity-Associated NAFLD

    Sorry, accepting new patients by invitation only

    The overall goal of this collaborative research program is to develop, validate and translate advanced quantitative magnetic resonance (MR) biomarkers of obesity-associated non-alcoholic fatty liver disease (NAFLD). This protocol represents the research plan for two distinct phases. The first phase is an optimization phase. The second phase is designed to complete a rigorous test of conventional and advanced MRE techniques. Complementary anthropometric, laboratory, and MR measures will also be collected to characterize the cohort and identify factors that affect MRE performance

    at UCSD

Our lead scientists for Liver Disease research studies include .

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