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Clinical Research Studies

The lab of Dr. Jonathan Stine at Penn State Health Liver Center and Penn State College of Medicine is leading a number of studies seeking to improve outcomes for people with nonalcoholic fatty liver disease, liver cancer, liver disease-related coagulation disorders and other liver conditions.

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Ongoing Studies

EXALT (Exercise Attenuates Liver Tumors) Expand answer

Study overview

The overall goal of this research study is to test the effect of exercise to delay or avert the recurrence of hepatocellular carcinoma (HCC), a type of liver tumor, and gain information regarding the potential molecular mechanisms of HCC tumor inhibition by exercise.

Study status

This study is currently enrolling participants 18 and older, of any gender.

See details on Studyfinder

NASHFit (Nonalcoholic Steatohepatitis Fitness Intervention in Thrombosis) Expand answer

Study overview

Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the United States. The most advanced forms of NAFLD are associated with increased liver-related mortality and lower overall survival. The current standard of care for NAFLD is lifestyle changes through diet and exercise – the human genome and regulation of gene expression is influenced by physical activity.

NAFLD is a prothrombotic state with changes in all three phases of hemostasis leading to clinically important clotting events, and exercise can improve coagulation in healthy people. This study seeks to work toward an answer to the question “Can lifestyle changes effectively mitigate the increased risk of clotting in patients with NAFLD?” The initial focus is on the at-risk population genetically susceptible to advanced disease.

Study status

This study is currently enrolling participants with NAFLD, 18 and older, of any gender.

See details on Studyfinder

PROC-BLeeD (Bleeding in Hospitalized Patients with Liver Disease Undergoing Invasive Procedures) Expand answer

Study overview

Patients with cirrhosis are frequently hospitalized and often undergo procedures. Knowledge surrounding bleeding risk is sparse and practice patterns vary across centers in regard to bleeding prophylaxis. The goal of this study to is to obtain more knowledge about risk factors for procedural-related bleeding in patients with cirrhosis and to develop a predictive model to risk stratify patients before undergoing procedures. Through collaboration from centers across the world, this study should provide information on the prevalence of bleeding and variation in practice patterns for prophylaxis.

Study status

This multi-site study is currently recruiting participants with cirrhosis who undergo at least one invasive nonsurgical procedure at admission or during hospitalization, 18 and older, of any gender.

See details on ClinicalTrials.gov

Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis Expand answer

Study overview

This study is looking for patients with compensated cirrhosis as the result of nonalcoholic steatohepatitis (NASH). NASH is the result of too much fat within the liver, resulting in injury and death to individual liver cells. The presence of injury like this is followed by progressive formation (laying down) of liver fibrosis (scar tissue), and the result of this is increased liver stiffness. As more and more fibrosis is formed and laid down in the liver, the outcome is cirrhosis. Compensated cirrhosis means the liver has become very scarred but can still perform many important bodily functions. This research is being done to find out how safe and effective obeticholic acid (also known as OCA) may be in improving compensated cirrhosis caused by NASH.

Study status

This study is currently recruiting participants with NASH cirrhosis, 18 and older, of any gender.

See details on Studyfinder

Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis Expand answer

Study overview

The primary objectives of this study are to evaluate the effect of obeticholic acid treatment compared to placebo on histological improvement and liver-related clinical outcomes in patients with noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Study status

This study is currently recruiting participants with NASH, stage 2 or 3 liver fibrosis and stable body weight, 18 and older, of any gender.

See details on Studyfinder

Other Studies

PIVOT-AC Expand answer

Study overview

Patients with cirrhosis are hypercoagulable and at increased risk for clotting events. Portal vein thrombosis (PVT) is a common complication in patients with cirrhosis. PVT is a potentially life-threatening occurrence, complicating transplant candidacy and reducing five-year post-transplant survival. Restoring normal physiologic coagulation may prevent the development of PVT.

This 72-week study aims to prevent PVT using Antithrombin-III to restore physiological levels.

Study status

This study is not yet recruiting participants.

TARGET-HCC Expand answer

Study overview

This is a longitudinal, observational study of patients being managed for hepatocellular carcinoma (HCC) in usual clinical practice. TARGET-HCC aims to create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

Study status

This study has completed enrollment.