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UC Davis Health Clinical Studies

A Study of Experimental CC-90001 For Non-alcoholic Steatohepatitis (NASH) and Stage 3 or 4 Liver Fibrosis

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We invite you to take part in a research study because you have been diagnosed with nonalcoholic steatohepatitis (NASH). NASH is a type of fatty liver disease in which fat builds up in your liver and over time causes inflammation (swelling) and liver cell damage. The purpose of this study is to test an experimental study drug called CC-90001. This study will test 3 doses of CC-90001 (100 mg, 200 mg and 400 mg, given by mouth, once daily). It will be compared to placebo (a “sugar pill”, an inactive substance that contains no medicine but looks exactly the same). This study is being done to test the effect of CC-90001 on your liver, and how well your body tolerates CC-90001. The study drug, CC-90001, has not been approved for the treatment of NASH and its use in this study is experimental.

Drug study, Phase 2
Any, age 18 years or older

A Study of the Safety and Effectiveness of Experimental Cilofexor for Primary Sclerosing Cholangitis (scarring of bile ducts)

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We invite you to take part in a research study because you have primary sclerosing cholangitis (PSC). PSC is a chronic disease which causes scarring of the bile ducts. When the bile ducts are damaged, the ducts become hard and narrow and this can block the flow of bile which can cause damage to the liver over time. This study will test an experimental drug named GS-9674 (also referred to as cilofexor). It will be used for the treatment of primary sclerosing cholangitis (PSC). PSC can be without symptoms, especially early in the disease. Some symptoms of PSC can include fatigue (feeling tired), itching, and jaundice (yellowing of eyes and skin). The symptoms of PSC are related to the blockage of bile flow from the scarred bile ducts and a build-up of bile acids. Patients with PSC can develop cirrhosis (severe scarring of the liver). This can lead to liver failure. PSC is also a major risk factor for the development of cancer of the bile ducts (cholangiocarcinoma). The only effective treatment for PSC is liver transplantation. This involves removing the damaged liver and replacing it with a healthy one from a donor. Experimental GS-9674 is being developed to reduce bile acids. Elevated bile acids contribute to symptoms of PSC including inflammation and fibrosis (scarring) in the liver.

Drug study, Phase 3
Any, age 18 to 70 years old

Do you have Fatty Liver or NASH? Participate in a study

We are evaluating a new investigational medicine for the treatment of NASH

We're inviting people with fatty liver or nonalcoholic steatohepatitis (NASH) to participate in a research study. The goal of this study is to see if an investigational medicine called Elafibranor is safe and effective for the treatment of NASH. Nonalcoholic steatohepatitis or NASH is a liver disease that is affecting millions of Americans. It is marked by liver inflammation and damage caused by a buildup of an unhealthy amount of fat in the liver. NASH may progress to scarring and lasting damage to the liver. Currently, no FDA approved medications are available. You will receive study medication and study evaluations at no cost, and compensation for your time is available. Experienced clinicians at the UC Davis Department of Gastroenterology and Hepatology will take care of all study participants.

Phase 3, Drug study
Any, age 18 - 75 years

A Study of Experimental Medicine VAY736 For Autoimmune Hepatitis

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The purpose of the study is to find out if:  Experimental VAY736/ianalumab can help to treat patients with autoimmune hepatitis  To see if it is safe for autoimmune hepatitis patients to take VAY736/ianalumab  To compare different dosages of VAY736/ianalumab to see which one works best  To see if using VAY736/ianalumab on top of standard treatment is better than using no active treatment (placebo) on top of standard treatment. Standard treatment for autoimmune hepatitis is usually steroids or anti-inflammatory medicines (azathioprines). These treatments can prevent the immune system from attacking the liver. They are effective for most patients with autoimmune hepatitis. Approximately 25% of autoimmune hepatitis patients do not completely respond to treatment or cannot tolerate these drugs. This study is for patients whose disease did not respond well to or could not tolerate standard treatment. VAY736/ianalumab is a medicine which has not yet been approved by FDA for the treatment of patients with your medical condition. This study drug is experimental and it has not yet been demonstrated to be effective for the treatment of autoimmune hepatitis.

Biological study, Phase [/2/,/ /3/]
Any, age 18 to 75 years old

A Study of Experimental Obeticholic Acid For Primary Biliary Cholangitis (inflammation and scarring of liver bile ducts)

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This study is for people with primary biliary cholangitis (also known as primary biliary cirrhosis or PBC). Because of your condition, you may be eligible for a research study on an investigational drug for your condition. The Sponsor of this study, Intercept Pharmaceuticals, Inc., is trying to learn more about obeticholic acid (also known as OCA). We want to know its effect on your PBC condition when given with ursodeoxycholic acid (UDCA). OCA (Ocaliva) has been approved in several countries (including the United States, Canada, and Europe) for the treatment of PBC. As an approved drug, OCA may be commercially available, or can be purchased to treat patients with your condition, PBC. In this study, OCA is an investigational drug (also called a study drug). This means that OCA is being tested to obtain more information about its effects on PBC. The investigational drug, OCA, is a modified (manmade) version of a natural compound made in the liver called a bile acid. Bile acids are used by the body to help with digestion and have additional effects on liver function. The purpose of this study is to find out how study drug, OCA, is absorbed and distributed through the body. We hope to determine the chemical changes of the study drug while it is in the body, and identify how the study drug is excreted out of the body. This is called pharmacokinetics, or PK. The Sponsor will also be studying the safety of OCA.

Drug study, Phase 4
Any, age 18 years or older

Primary Biliary Cholangitis with incomplete response or intolerant to ursodeoxycholic acid? Participate in a clinical trial

Help us evaluate if a new investigational drug is safe and effective in the treatment of PBC

We invite you to take part in a research study because you have primary biliary cholangitis (PBC) and you are not responding well enough to or can't tolerate ursodeoxycholic acid. You must have been taking a stable dose of ursodeoxycholic acid (UDCA) for the past twelve months, OR you're not able to tolerate UDCA due to side effects. This study will test the safety and efficacy of an investigational medicine called seladelpar. Previous research has shown that seladelpar may help treating the signs and symptoms of PBC, lower your alkaline phosphatase level, and decrease itching. Primary Biliary Cholangitis (PBC) is a autoimmune chronic liver disease that destroys the bile ducts within the liver. You will receive all study medication and study evaluations at no cost, and compensation for your time may be available.

Drug study, Phase 3
Any, age 18 to 75 years old

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

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This study will learn more about people with hepatitis B. By doing this study, researchers hope to: • Find out more about patients that have hepatitis B, including their age, race/ethnicity, and other medical conditions they may have • Learn about different medications, procedures, and other treatments that are being used to manage hepatitis B. • Understand changes that may be happening in the liver or throughout the body by looking at reports such as those for scans, tests, and biopsies

Other study
Any, age 18 years or older

A Study of the Experimental Medicine Obeticholic Acid For Nonalcoholic Steatohepatitis (NASH) (accumulation of liver fat)

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The study team hopes to find out how safe and effective the experimental drug obeticholic acid (also known as OCA) is. It will be studied in patients with compensated cirrhosis caused by NASH. NASH (nonalcoholic steatohepatitis) is the accumulation of liver fat in people who drink little to no alcohol. There are no therapies approved for the treatment of NASH. OCA (the brand name is Ocaliva) has been approved by the FDA for other liver conditions. In this study, OCA is an experimetnal drug because it has not been approved to treat cirrhosis as the result of NASH. OCA is a manmade version of a natural compound made in the liver called bile acid. Bile acids are used by the body to help with digestion and also have additional effects on liver function

Drug study, Phase 2
Any, age 18 to 75 years old