Clinical Trials

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A Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 once daily on Steatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH)
The Primary Objective is to evaluate the efficacy of GFT505 80mg and GFT505 120mg daily versus placebo in reversing histological steatohepatitis without worsening of fibrosis. (REF# Pro00039585)

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC)
The primary objective of this study is to evaluate whether GS-6624 is effective at preventing the progression of liver fibrosis in subjects with PSC. (REF# Pro00041834)

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects with Advanced Liver Fibrosis but not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH).
The primary objective of this study is: to evaluate whether GS-6624 is effective at preventing the progression of liver fibrosis in subjects with NASH. (REF# Pro00041486)

Ulcerative Colitis Study
Duke University Medical Center is conducting a research study to see if the experimental study drug, ASP3291, is safe and effective at controlling ulcerative colitis without causing significant side effects. (REF# Pro00038948)

Hepatitis C and Human Immunodeficiency Virus Type 1 (HIV) Research Study (Gilead GS334-0123)
Duke University Medical Center is conducting a research study to evaluate the antiviral
efficacy, safety, and tolerability of GS-7977 with RBV for the treatment of chronic HCV
in subjects who are co-infected with HIV. (REF# Copernicus Group IRB: DUK2-12-239; Duke eIRB: 38965)

Crohn’s Disease Study -- 3001 (UNITI-1)
Duke University Medical Center is conducting a study to determine whether or not treatment with ustekinumab improves symptoms of Crohn’s disease, and to look for any possible side effects. (REF# Pro00032439)

Hepatitis C Research Study -- Vertex (VX-950-116)
Patients with chronic hepatitis C genotype 1 studies who did not respond to previous treatment with pegylated interferon and ribavirin are needed for a clinical study to examine safety and effects of the combination of telaprevir, peginterferon alfa-2a (Peg-IFN) and ribavirin (RBV). (REF# Copernicus Group IRB: DUK1-11-491; Duke eIRB: 34457)

Primary Biliary Cirrhosis (PBC) Study
Patients with primary biliary cirrhosis are needed for a study to examine the safety and efficacy of the investigational drug obeticholic acid. (REF# 34651)

Ulcerative Colitis Study -- (MERIT-UC)
Patients with active ulcerative colitis (UC) are needed for a study examining the safety and efficacy of methotrexate, an investigational drug. (REF# 25756)

Non-Alcoholic Fatty Liver Disease (NAFLD) Repository
Patients undergoing liver biopsy at Duke can participate in this informational database and tissue repository that will ultimately aid us in gaining a better understanding of non-alcoholic fatty liver disease and other liver disease processes. (REF# 8015)

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