Clinical Research Trials

Gastro Florida offers clinical research trials in which volunteers participate and receive a trial treatment for a particular condition while under supervision. There are multiple advantages for participating in a clinical research trial. They include:

  • Access to the latest treatments before they are widely available
  • Therapeutic options when other methods have not worked
  • Playing an active role in your health care
  • Help others by contributing to science and research
  • Research may lead to better treatment of their condition
  • No monetary cost to the patient

 

Please contact Gastro Florida’s Lead Clinical Research Coordinator, Shannon Brewington at This email address is being protected from spambots. You need JavaScript enabled to view it. for more information about the active trials listed below.

Active Trials

Crohn’s Disease

Genentech: Bergamot

GA29144: 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.

Nonalcoholic Fatty Liver Disease (NAFLD)/Steatohepatitis (NASH)

Prometheus

16HEP01: Procurement of blood samples from subjects with diagnosed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) for use in the development of a liver fibrosis test

Tobira: Aurora

Protocol 3152-301-002: A phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of cenicriviroc for the treatment of Liver Fibrosis in adult subjects with nonalcoholic steatohepatitis

Primary Biliary Cholangitis

GlaxoSmithKline: Study 201000

A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis. (GLIMMER: GSK2330672 trial of Ibat inhibition with Multidose Measurement for Evaluation of Response)

Target

Target-PBC: A 5-year longitudinal observational study of patients with Primary Biliary Cholangitis

Ulcerative Colitis

AbbVie

M14-234: JAK 1 inhibitor for induction and maintenance therapy in subjects with moderately to severely active Ulcerative Colitis.

Celgene

A phase III, multicenter, randomized, double-blind, placebo-controlled trial of oral RPC1063 as induction and maintenance therapy for moderate to severe Ulcerative Colitis

Genentech: Hickory

GA28950: 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.

Genentech: Laurel

GA29102: Etrolizumab compared with placebo in patients with moderate to severe active Ulcerative Colitis who are naïve to TNF inhibitors.

AbbVie: Protocol M14-033

A double-blind, randomized, multicenter study of higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Ulcerative Colitis

Shire: Figaro UC 302

SHP647-302: A Phase III randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study of SHP647 as induction therapy in subjects with moderate to severe Ulcerative Colitis

Shire: Figaro UC 303

SHP647-303: A Phase III randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study of SHP647 as maintenance therapy in subjects with moderate to severe Ulcerative Colitis

Shire: Aida

SHP647-304: A Phase III long-term safety extension study of SHP647 in subjects with moderate to severe Ulcerative Colitis

Takeda: Entyvio

Vedolizumab-4014: A phase IV open-label study to evaluate Vedolizumab IV dose optimization on treatment outcomes in non-responders with moderately to severely active Ulcerative Colitis.