Research

Leading the Way

Asheville Gastroenterology Associates is currently engaged in the following clinical trials. If you or someone you know, is over 18 years of age and are interested in any of our current clinical trials listed, you may contact us for more information to see if you qualify. If eligible, most trials will cover the cost of trial-related expenses and/or stipend. Email research@ashevillegastro.com your contact information and a study coordinator will contact you.


COLORECTAL CANCER STOOL COLLECTION

1) Exact Sciences 2018-07: Details coming soon


CELIAC

1) Innovate Celiac: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Treatment of Celiac Disease

Read More

CROHN'S DISEASE

1) GIVEN/ Medtronics- “BLINK” study- Multicenter, prospective, randomized study comparing PillCam®

Crohn’s capsule endoscopy (CE) to ileocolonoscopy (IC) plus MRE for detection of active Crohn’s disease (CD) in the small bowel and colon in subjects with known CD and mucosal disease (the BLINK study)

Read More

2) Celgene RPC01-3201: Phase III Ozanimod induction study for moderately to severely active Crohn’s disease

Read More

3) Janssen “GALAXI” -Protocol CNTO1959CRD3001: "A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease"

Read More

FECAL CALPROTECTIN

1) CALFE Stool Sample Collection Protocol-DIASORIN

Read More

Gastroparesis

1) Allergan-RLM-MD-01/03/04- A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

Read More

GERD

1) IRONWOOD: Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors

Read More

GI/LIVER DISEASE Blood Assay study:

1) SEERPRO: A Prospective Blood Sample Collection Study to Evaluate a Panel of Protein-based Biomarkers


LIVER/HCV:

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

Read More

2) Home Access Health-Elevated AST- blood assay comparison study- 1 visit- Finger stick blood vs venous blood.

3) DILIN- UNCCH- Dr. Hayashi-Evidence of liver injury that is known/suspected to be related to consumption of a drug or Complementary-Alternative Med (CAM) with past 6-months (excluding acetaminophen) with no competing cause of acute liver injury. NO autoimmune hep, PBC, PSC, etc. that confounds ability to diagnose DILI.

Read More

NON-ALCOHOLIC FATTY LIVER DISEASE:

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

Read More

2) A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis-(Intercept Pharmaceuticals)

Read More

3) A Multicentre Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis-RESOLVE-IT (GenFit)

Read More

3) NOVARTIS: A randomized, double-blind, multicenter study to assess the safety, tolerability and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis (TANDEM)

Read More

PRIMARY BILIARY CHOLANGITIS

1) CymaBay: A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in Subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic Acid.

Read More

SCREENING COLONOSCOPY IN AGES 45-49:

1) Exact Sciences 2018-10: An Evaluation of a Multi-target Stool DNA (mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer


ULCERATIVE COLITIS:

1) Safety and Efficacy Trial of RPC1063 for Mod to Sev Ulcerative Colitis-TRUE NORTH-Receptos/Celgene)

Read More

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

Read More

3) AbbVie-M14-234 study, “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis ” and, the M14-533 study, “A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)”

Read More

4) AbbVie-M14-675 study:  A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis  

Read More

5) Seres: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER‑287 in Adults with Active Mild-to-Moderate Ulcerative Colitis


Our current/pending trials include the following disease states:

  • Celiac Disease
  • Colon Cancer screening/Blood & Stool DNA sampling
  • Drug Induced Liver Disease Injury (in conjunction with UNC-Chapel Hill)
  • Eosinophilic esophagitis
  • Fatty liver with/without cirrhosis
  • Gastroparesis
  • Hepatitis-C observational/registry studies
  • Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis)
  • Primary Biliary Cholangitis

Please Note: We keep an ongoing list of eligible candidates for many 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. Recent trials have included: Irritable bowel syndrome with constipation or diarrhea, celiac disease, proctitis, hemorrhoids, iron deficiency anemia, bowel preps, non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), Hepatitis-C treatment studies, hepatic encephalopathy/compensated cirrhosis, as well as other registry studies for GI/liver diseases.

Take Control of Your Health

Whether you are looking for preventative care for colon cancer screening or seeking diagnosis and treatment for a gastrointestinal condition, we can help. We provide consultative and procedural services spanning the full spectrum of clinical gastroenterology and hepatology.

Navigation