Current Trials:

 

Asheville Gastroenterology Associates, P.A.

Now ENROLLING Research subjects in the following clinical trials:

Ulcerative Colitis:

1) Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn’s Disease (Celgene)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02596893?term=Celgene+Crohn%27s+GED&rank=1

2) Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis (Receptos/Celgene)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02435992?term=Receptos+Celgene+UC+true+North&rank=1&submit_fld_opt

3) A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors-LAUREL-(Genentech-Hoffman La Roche)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02165215?term=ulcerative+colitis&recr=Open&state1=NA%3AUS%3ANC&age=12&phase=123&rank=4

4) A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Patients Who Are Refractory to or Intolerant of TNF Inhibitors (HICKORY)-(Genentech-Hoffman La Roche)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02100696?term=ulcerative+colitis&recr=Open&state1=NA%3AUS%3ANC&age=12&phase=123&rank=3

5) A Long-Term Registry of Humira® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)-LEGACY-(ABBVIE)

LINK:  https://clinicaltrials.gov/ct2/show/NCT01848561?term=abbvie&recr=Open&type=Obsr&state1=NA%3AUS%3ANC&rank=1&submit_fld_opt=

Crohn’s Disease:

1) Safety and Efficacy of GS-5745 in Participants with Moderately to Severely Active Crohn’s Disease (Gilead Sciences)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02405442?term=gilead+crohn&rank=1

2) Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients with CD Receiving Anti-TNF Therapy (PIONEER-CD)-(Nestle/Robarts)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02793778?term=robarts+pioneer+Crohn%27s&rank=1

3) A Study of the Safety and Efficacy of Etrolizumab in Patients with Moderately to Severely Active Crohn’s (Bergamot & Juniper Open-Label Extension)-(Genentech-Hoffman-La Roche)

LINK: https://clinicaltrials.gov/ct2/show/NCT02394028?term=crohn%27s&recr=Open&state1=NA%3AUS%3ANC&phase=123&rank=4&submit_fld_opt=

4) Smoking cessation:  A University of Chicago study investigating the effectiveness of different informational media on Crohn’s disease patients who continue to smoke after their diagnosis. Assessment of the adequacy of the media to inform patients of the harms of smoking, as well as how successful subjects are in quitting or attempting to quit within a 6 month time frame.  This is a web-based interactive module in conjunction with the Centers for Disease Control and Prevention’s standard educational material.

Non-alcoholic Fatty Liver Disease (NASH):

1) EmricasaN, a Caspase inhibitOR, for Evaluation in Subjects with Non-Alcoholic Steatohepatitis (NASH) Fibrosis (ENCORE-NF)-(Conatus Pharmaceuticals)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02686762?term=conatus+nash&rank=1&submit_fld_opt=

2) Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment (REGENERATE)-(Intercept Pharmaceuticals)

Link:  https://clinicaltrials.gov/ct2/show/NCT02548351?term=Intercept+Pharmaceuticals&type=Intr&cond=NASH&state1=NA%3AUS%3ANC&age=12&phase=123&rank=1

3) A 5-year longitudinal, observational study of patients with nonalcoholic fatty liver disease or nonalcoholic steatohepatitis (NASH)-(TargetPharma Solutions)

Link:  TBD

Hepatitis-C REGISTRY:

1) HCV-TARGET-Obervational Hepatitis C Therapeutic Registry and Research Network (UF-UNCCH)

LINK:  https://clinicaltrials.gov/ct2/show/NCT01474811?term=Target+HCV&recr=Open&rank=1

Iron Deficiency Anemia:

1) A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (FIRM)-(AMAG Pharmaceuticals)

Link:  https://clinicaltrials.gov/ct2/show/NCT02694978?term=AMAG+iron+deficiency&rank=8

Irritable Bowel Syndrome with Constipation:

1) A 12-Week Study with a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C (T3MPO-1)-(Ardelyx Pharmaceuticals)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02621892?term=Ardelyx+IBS&rank=3

Chronic Diarrhea of unknown cause:

1) A Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solution in Subjects with Chronic Diarrhea and Sucrase Deficiency (GSID-E)-(QOL Medical)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02784067?term=qol+sucrase&rank=1

Eosinophilic Esophagitis:

1) Study of Dupilumab in Adult Patients with Active Eosinophilic Esophagitis (EoE)-(Regeneron)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02379052?term=regeneron+eoe&rank=1

Gastroesophageal Reflux Disease (GERD):

1) A Randomized, Double-blind, Placebo-controlled, Trial of IW-3718 for 8 Weeks in Patient with Symptomatic GERD-(Ironwood Pharmaceuticals)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02637557?term=ironwood+GERD&rank=2

Colon Cancer:

1) Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers (Exact Sciences)

LINK:  https://clinicaltrials.gov/ct2/show/NCT02503631?term=exact+Sciences&rank=7&submit_fld_opt=

Bowel Prep:

1) Bowel Prep Comparison Study for Patients Undergoing Colonoscopy.

LINK:  TBD

Upcoming trials also include patients with Celiac Disease….

IF YOU, A FRIEND OR FAMILY MEMBER ARE OVER 18 YEARS OF AGE AND ARE INTERESTED IN ANY OF THE CLINICAL TRIALS LISTED, PLEASE CONTACT THE ASHEVILLE GASTROENTEROLOGY RESEARCH DEPARTMENT FOR MORE INFORMATION TO SEE IF YOU MIGHT QUALIFY.  IF ELIGIBLE, MOST TRIALS WILL COVER THE COST OF TRIAL-RELATED EXPENSES AND/OR STIPEND. PLEASE PROVIDE YOUR CONTACT INFORMATION WITH YOUR E-MAIL TO RESEARCH@ASHEVILLEGASTRO.COM  AND A STUDY COORDINATOR WILL CONTACT YOU!

 

Please Note:  We keep an ongoing list of eligible candidates for many GI disease states so if we don’t currently have an enrolling trial, you may request we keep your name in our referral database for any upcoming GI-related trials.