Clinical Trials

During FY 2014, the division had 16 ongoing clinical trials and launched four new ones. They include:

SALIX: A randomized, double-blind, placebo-controlled, dose-ranging, multicenter study to assess the efficacy and safety of rifaximin soluble solid dispersion (SSD) tablets for the prevention of complications in subjects with early decompensated liver cirrhosis
Collection of frozen tissue at time of liver biopsy
Histopathological predictors in the clinical outcome of patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis
Peg Base: Non-interventional, prospective, cohort study of the effectiveness, safety, and utilization of two approved pegylated interferon-based direct acting antiviral triple therapies in the management of genotype 1 chronic hepatitis C in routine clinical practice in the USA
Levels of inflammatory cytokines tumor necrosis factor alpha, interleukin-1 and interleukin-6 in patients with autoimmune hepatitis

Frequency of C. difficile infections in patients with inflammatory bowel disease
IMMUNITI: A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of Ustekinumab maintenance therapy in subjects with moderately to severely active Crohn’s disease
Retrospective Chart Review of Dose Escalation of Biologic Therapies in IBD Patients
Risk Factors for Developing More Severe Forms of Celiac Disease
ROBARTS A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy To Empiric Dose Intensification for the Management of Inflammatory Bowel Disease

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 compensated cirrhosis secondary to non-alcoholic steatohepatitis (NASH)
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)
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 role of proton pump inhibitors and H2-blockers in gastric antral vascular ectasia (retrospective arm)
Treatment of type I hepatorenal syndrome (HRS) with pentoxyfylline: a placebo-controlled, blinded pilot study
Investigation of the variability of MELD scores in liver transplant listed patients based on use of differing thromboplastin reagents

Resistin-like molecule beta (RELM-beta) and its role in intestinal inflammation in inflammatory bowel disease
Nicolas Intagliata, PI
Factors associated with rates of culture positive spontaneous bacterial peritonitis at University of Virginia
Microparticles in liver diseases

CLARITY – Clinical Investigation to Evaluate Removal of the Evolution Esophageal Stent – Fully Covered
Database of Endoscopic Procedures, Complications, and Outcomes
Use of esophageal stents in benign and malignant diseases

A Phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended population of treatment naive patients that includes those ineligible to receive peginterferon.
Studying Coagulation Profiles in Liver Disease Patients
Cost effectiveness of rifaximin in reducing re-admission for hepatic encephalopathy

Endoscopic ultrasound guided rendezvous vs. advanced ERCP techniques for biliary access
Evaluation of the effectiveness of Evolution Biliary Stent System
Prevalence of intestinal metaplasia and associated risk factors
Photodynamic therapy as a method of providing local control of cholangiocarcinoma in patients awaiting protocol liver transplantation
Bleeding risk of cecal polypectomies