Hepatology Clinical Trials

As a patient at Cedars-Sinai, you will have access to the latest clinical trials and research for hepatology. Backed by a respected team of specialists and researchers, our clinical trials aim to further the advancement of diagnosing and treating your hepatology condition.

Questions? See the Clinical Trials FAQs.

Condition:

Liver cirrhosis, hepatocellular carcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosed with liver cirrhosis
  • Requires an upper gastrointestinal endoscopy by a Cedars-Sinai, UCLA and Veterans Affairs Greater Los Angeles Healthcare System gastroenterologist for standard of care

Summary:

This study focuses on patients who have liver cirrhosis. There is growing evidence that individuals with cirrhosis have changes in their gastrointestinal systems, including changes to the types of microbes that make up their gastrointestinal tract. Changes to these microbes may lead to inflammation (swelling) and other issues related to a worsening of liver disease. In this study, researchers aim to measure and evaluate changes in the intestines and throughout the entire body of patients with liver cirrhosis by collecting tissue and fluid samples from the small intestine (duodenum), as well as blood samples. In order to investigate the lifestyle factors that might be associated with these changes, participants will also be asked to complete questionnaires about dietary intake, lifestyle habits, medications and medical history. Patients will be followed over time to study changes in their disease.

Condition:

Nonalcoholic fatty liver disease, cirrhosis, hepatocellular carcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • History of nonalcoholic fatty liver disease with or without cirrhosis or hepatocellular carcinoma diagnosed within the last 6 months

Summary:

This study focuses on patients from Cedars-Sinai and Veteran's Administration Greater Los Angeles Healthcare System who have liver disease. Researchers believe that differences in gut bacteria and the products of these bacteria, together with other factors such as diet and body composition, may help to explain why some people with nonalcoholic liver disease progress to liver cirrhosis or cancer. In this study, researchers will evaluate the differences between biomarkers measured in participants' specimens, clinical data, and questionnaire data to learn more about why nonalcoholic fatty liver disease progresses in some people.

Condition:

Hepatocellular carcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosis of liver cirrhosis
  • Diagnosis of hepatocellular carcinoma

Summary:

This study focuses on individuals who have been diagnosed with an early-stage hepatocellular carcinoma (HCC) and who have been treated with therapies targeting the liver. The purpose of the study is to examine the effects that an investigational drug called pravastatin has on the time it takes for HCC to occur again in patients with early-stage HCC. Researchers believe that pravastatin, in combination with therapies targeting the liver, may delay or protect against HCC occurring again.

Pravastatin is a type of statin that is approved by the U.S. Food and Drug Administration (FDA) for various conditions. However, it is not approved by the FDA to delay or protect against HCC occurring again. The study will compare the effects of pravastatin against the effects of a placebo (inactive substance). Participants will be randomly assigned to receive either pravastatin or a placebo.

Condition:

Liver cirrhosis

Summary:

This study focuses on patients with liver cirrhosis (scarring of the liver which results in abnormal liver function). The purpose of the study is to compare the safety and effects of simvastatin in individuals with liver cirrhosis who are at an increased risk for liver cancer. Participants will receive either simvastatin or placebo (inactive substance). Simvastatin is approved by the U.S. Food and Drug Administration for various conditions, but its use in this study is investigational. Previous studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. Researchers believe that this anti-inflammatory effect of simvastatin may delay disease progression to cancer in patients with liver cirrhosis.

Condition:

Primary biliary cirrhosis

Key Inclusion Criteria:

  • Definite or probable PBC diagnosis
  • At least 18 years old
  • A mean total bilirubin greater than upper limit of normal (ULN) and ≤3 X ULN or an alkaline phosphatase >5 X ULN

Summary:

This study focuses on patients who have primary biliary cholangitis (PBC), a progressive liver disease caused by a buildup of bile that results in damage to the bile ducts that drain bile from the liver. The purpose of the study is to evaluate the investigational use of a drug called obeticholic acid (also known as OCA) and its effect on PBC when given with ursodeoxycholic acid. OCA is a man-made version of a natural compound produced in the liver called bile acid. Researchers aim to determine the safety and effectiveness of OCA in delaying specific medical conditions or health-related issues that can occur in patients with PBC.

The current standard of care for adults with PBC is ursodeoxycholic acid for an indefinite length of time. In this study, researchers will compare OCA to the standard treatment to learn which is more effective.