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UVA Department of Medicine: FY 2015 Annual Report

Clinical Trials

Division of Gastroenterology & Hepatology
CLINICAL TRIALS

Division faculty members are serving as principal investigators on a number of trials, including:

Curtis Argo, MD

  • Collection of frozen tissue at time of liver biopsy.
  • 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.
  • An update on spontaneous bacterial empyema.
  • Should Vasopressin be a pressor of choice for cirrhotic patients with septic shock?
  • Grant: Historical and Biochemical Impact of Pravastatin in Patients with NAFLD.

Brian Behm, MD

  • Digestive Health Research Center Tissue Banking Service and Database.
  • Effectiveness of Humira® (Adalimumab) in subjects with moderately to severely active Crohn’s disease (CD).
  • Phase III, randomized double-blind, placebo-controlled, multicenter study to evaluate the efficacy (maintenance of remission) and safety of Etrolizumab compared with placebo in patients with moderate to severe active ulcerative colitis who are naïve to TNF Inhibitors (GA29102).
  • An open-label extension and safety monitoring study of moderate to severe ulcerative colitis patients previously enrolled in Etrolizumab Phase III Studies (GA28951).
  • A multicenter, randomized, double-blind, placebo-controlled study of ABT-494 for the induction of symptomatic and endoscopic remission in subjects with moderately to severely active Crohn’s disease who have inadequately responded to or are intolerant to anti-TNF therapy (M13-740).
  • Phase III, double-blind, placebo-controlled, multicenter study of the efficacy and safety of Etrolizumab during induction and maintenance in patients with moderate to severe active ulcerative colitis who are refractory to or intolerant of TNF inhibitors (GA28950).
  • A Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Etrolizumab as an induction and maintenance treatment for patients with moderately to severely active Crohn’s disease (GA29144).
  • An open-label extension and safety monitoring study of patients with moderately to severely active Crohn’s disease previously enrolled in the Etrolizumab Phase III Protocol GA29144 (GA29145).
  • Grant: Adenosine receptor-mediated effects of Clostridium difficile toxins in humans.

Stephen Caldwell, MD

  • Omega-3 fish oil supplements versus placebo in nonalcoholic steatohepatitis (NASH).
  • The role of proton pump inhibitors and H2-blockers in gastric antral vascular ectasia.
  • A Phase IIb, 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 in compensated cirrhosis secondary to non-alcoholic steatohepatitis (NASH).
  • A Phase IIb, 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 Phase IIb, 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 role of proton pump inhibitors and H2-blockers in gastric antral vascular ectasia retrospective arm.
  • A Phase II, randomized, double-blind, placebo-controlled study of IMM-124E for patients with non-alcoholic steatohepatitis (IMM-124E 2001).
  • A Phase II, randomized, double-blind, placebo-controlled, parallel-group, multiple center study to evaluate the safety, tolerability and efficacy of NGM282 administered for 12 weeks in patients with histologically confirmed non-alcoholic steatohepatitis (NASH) – protocol number 15-0105.

Steven Cohn, MD

  • Resistin-like molecule beta (RELM-beta) and its role in intestinal inflammation in inflammatory bowel disease.
  • Intestinal cell kinase in intestinal homeostasis and inflammation.
  • Research training in digestive diseases (National Institutes of Health T32 training grant).

Jeanetta Frye, MD

  • Safety of endoscopic procedures in neutropenia.

Zachary Henry, MD

  • Prevalence and treatment of acute coronary syndromes (ACS) in cirrhotic patients.
  • Characterizing familial forms of non-alcoholic steatohepatitis.

Nicolas Intagliata, MD

  • Microparticles in liver diseases.
  • Factors associated with rates of culture positive spontaneous bacterial peritonitis at University of Virginia.
  • Treatment of portal vein thrombosis and peripheral thrombosis in patients with portal hypertension.

Patrick Northup, MD

  • Safety, tolerability and coagulation effects of low and intermediate dose aspirin in patients with chronic liver disease: a pilot study.
  • Ascites after liver transplantation. Are traditional diagnostic measures applicable?

Steven Powell, MD

  • Determination of follow-up and test utilization of information in colorectal cancer patients with aberrant mismatch repair immunohistochemistry and potential Lynch syndrome.

Bryan Sauer, MD, MS

  • Does molecular analysis alter pancreatic cyst management? A retrospective multicenter study.
  • A prospective analysis of endoscopic ultrasound versus esophagogastroduodenoscopy in determining locoregional staging of esophageal malignancies.
  • Use of esophageal stents in benign and malignant diseases.
  • CLARITY – Clinical investigation to evaluate removal of the Evolution® esophageal stent – fully covered.

Neeral Shah, MD

  • Blood product use in cirrhotic patients undergoing hernia repair.
  • Studying coagulation profiles in liver disease patients.
  • Hepatitis C virus treatment variation based on insurance status.

Andrew Wang, MD

  • Prevalence of intestinal metaplasia and associated risk factors.
  • A comparison of plastic stents versus metal stents for treatment of biliary complications following orthotopic and living-donor liver transplant.
  • Gastrostomy-assisted transgastric ERCP is superior to single-balloon-enteroscopy-assisted ERCP in performing therapeutic interventions but is associated with more complications in patients with surgically altered anatomy.
  • Investigation of the use of fluoroscopy during ERCP.
  • Factors affecting progression and natural history of intestinal metaplasia of the stomach.
  • Comparison of photodynamic therapy and radiofrequency ablation as methods of providing local control of cholangiocarcinoma in patients awaiting protocol liver transplantation.
  • Investigation of the efficacy and safety of underwater endoscopic mucosal resection for gastric and small-intestinal polyps.
  • Endoscopic ultrasound-guided rendezvous vs. advanced ERCP techniques for biliary access.
  • Evaluation of the effectiveness of Evolution® biliary stent system – fully covered.
  • Rapid assessment of trainee endoscopic skills (RATES) study: a prospective multicenter study evaluating competence in EUS and ERCP among advanced endoscopy trainees.
  • A multicenter review of treatment outcomes in patients undergoing endoscopic-guided drainage of peri-pancreatic fluid collections.
  • Conventional endoscopic mucosal resection (EMR) vs. underwater EMR, a comparative retrospective study.
  • Submucosal injection assisted endoscopic resection vs. underwater EMR for large sessile colorectal polyps.
  • Clinical outcomes of patients undergoing endoscopic submucosal dissection (ESD) in the upper GI tract.
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