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Liver Disease clinical trials at UCSD

9 in progress, 7 open to eligible people

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  • 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.

    La Jolla, California

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

    open to eligible people ages 18-75

    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).

    La Jolla, California and other locations

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

    open to eligible people ages 18 years and up

    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.

    La Jolla, California and other locations

  • 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.

    La Jolla, California

  • 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.

    San Diego, California

  • 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.

    San Diego, California

  • 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.

    La Jolla, California and other locations

  • Vitamin E Dosing Study

    Sorry, not currently recruiting here

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

    La Jolla, California and other locations

  • Nonalcoholic Fatty Liver Disease in HIV Database

    Sorry, not currently recruiting here

    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).

    San Diego, California and other locations

Our lead scientists for Liver Disease research studies include .

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