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.


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)

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

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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"

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EOSINOPHILIC ESOPHAGITIS (EoE)

1) Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study (SHIRE)

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FECAL CALPROTECTIN

1) CALFE Stool Sample Collection Protocol-DIASORIN

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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

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LIVER/HCV:

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

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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.

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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)

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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)

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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)

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PRIMARY BILIARY CHOLANGITIS

1) A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid.

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ULCERATIVE COLITIS:

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

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

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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)”

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4) 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.

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