Jefferson University Hospitals

Digestive Health Institute

Research

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Research is at the heart of the the Digestive Health Institute at Jefferson, and it remains a crucial part of our mission. Each department carries out basic, translational, and clinical research designed to understand fundamental mechanisms of the digestive system. Our specialists translate that understanding into treatments for celiac disease and other digestive disorders.

Clinical Trials

The Division of Gastroenterology and Hepatology conducts a number of clinical trials in various aspects of digestive and liver diseases. For more information on any of these trials, please contact Cynthia Miller, RN, at 215-955-8108. To learn more about our team and educational opportunities, click here.

Learn more about registered studies by visiting clinicaltrials.gov.

Gastroenterology

Barrett’s Esophagus - Patients with Barrett's Esophagus

Study title: A multicenter case control study of the efficacy of EsoGuard™ on samples collected using EsoCheck™, versus upper endoscopy, for the diagnosis of Barrett’s esophagus with and without dysplasia, and for esophageal adenocarcinoma

Study population: Patients with Barrett’s esophagus (with and without dysplasia) or esophageal adenocarcinoma, and those without known Barrett’s esophagus or esophageal adenocarcinoma who are undergoing screening for these conditions

Sponsor: Lucid Diagnostics

Overview:The study will assess the performance (ability to detect Barrett’s with or without dysplasia, and esophageal adenocarcinoma) of the EsoGuard™ cell assay performed on specimens collected using the EsoCheck™ device as compared to the performance of upper endoscopy plus routine biopsies.

Primary outcome: To determine the sensitivity of EsoGuard™ for detecting non-dysplastic Barrett's Esophagus, low grade dysplastic Barrett’s, high grade dysplastic Barrett’s, and esophageal adenocarcinoma

Contacts:

PI: Anthony Infantolino, MD
Coordinator: Angela Mozier
Angela.Mozier@Jefferson.edu
Phone: 215-503-4683

Barrett’s Esophagus - Patients at high risk of developing Barrett's Esophagus

Study title: A multicenter, single-arm study of the efficacy of EsoGuard™ on samples collected using EsoCheck™ versus upper endoscopy for the diagnosis of Barrett’s Esophagus in an at-risk screening population

Study population: Patients high risk for Barrett’s esophagus, as defined by the American College of Gastroenterology, who are undergoing screening upper endoscopy

Sponsor: Lucid Diagnostics

Overview: All eligible patients will have the EsoGuard™ diagnostic assay performed on esophageal cells collected using the EsoCheck™ cell collection device

Primary Outcome:To evaluate the operating characteristics (sensitivity, specificity, positive predictive and negative predictive value) of EsoGuard™ for the diagnosis of Barrett’s Esophagus using samples collected with EsoCheck™.

Contacts:

PI: Anthony Infantolino, MD
Coordinator: Angela Mozier
Angela.Mozier@Jefferson.edu
Phone: 215-503-4683

Barrett’s Esophagus - The WATS3D U.S. Registry

Study Title: The WATS3D (Wide Area Transepithelial Sample Biopsy with 3-Dimensional Computer-Assisted Analysis) U.S. Registry

Study Population: The population targeted in this study includes patients undergoing WATS3D sampling during the enrollment EGD. Patients included in the Kaplan-Meier analysis will include any patient who has an initial WATS3D sampling and a second endoscopic examination separated by at least a 6-month interval

Sponsor: CDx Diagnostics

Overview: Enrolled subjects will undergo EGD with WATS3D sampling and forceps biopsies per routine care. Sites will track the order of the sampling methods. WATS3D samples will be analyzed by CDx Diagnostics as per standard protocol and forceps biopsies will be read by a pathologist at the enrolling institution or another laboratory as per routine care. Clinical and pathology data from the EGD, as well as the patient’s demographic and disease specific information, will be collected as part of this research. Pathology and disease-specific data will be collected at subsequent EGDs as long as the patient remains at the enrolling institution up to 10 years

Primary Outcome: 1) To describe the utilization of the WATS3D diagnostic test in real world clinical practice and to assess how these utilization patterns may affect incremental detection yield above that detected by routine forceps biopsies alone. 2) To describe the long term outcomes of patients undergoing WATS3D testing including: progression from Non-Goblet Cell Intestinal Metaplasia (NGCIM) to Barrett’s Esophagus; progression from Indefinite/Crypt Dysplasia to Low Grade Dysplasia and High Grade Dysplasia; and the incidence of Esophageal Adenocarcinoma (EAC), EAC mortality, and all-cause mortality

Contacts:

PI: Anthony Infantolino, MD
Coordinator: Angela Mozier
Angela.Mozier@Jefferson.edu
Phone: 215-503-4683

Celiac Disease

Study title: A phase 3, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of larazotide for relief of persistent symptoms in patients with celiac disease on a gluten free diet

Study population: Patients age 18 or older diagnosed with celiac disease who have followed a gluten free diet for at least 6 months and are experiencing symptoms related to celiac disease

Sponsor: Innovate Biopharmaceuticals, Inc.

Overview: Patients will be randomized to the study drug larazotide or to placebo and remain on a gluten free diet

Primary outcome: To assess the efficacy and safety of larazotide for the relief of persistent symptoms in adult celiac disease patients who are following a gluten free diet

Contacts:

PI: Anthony DiMarino, MD
Coordinator: Mike Matthews
Michael.Matthews@Jefferson.edu
Phone: 215-503-2545

Clostridium Difficile infection

Study title: A phase 3 open-label clinical study to evaluate the safety and tolerability of RBX2660 (microbiota suspension) in subjects with recurrent Clostridium difficile infection (CDI)

Study population: Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy, or have had at least two episodes of severe CDI resulting in hospitalization

Sponsor: Rebiotix

Overview: All eligible patients will receive an enema administered microbiota (intestinal microbes) suspension (RBX2660); Subjects may receive a second RBX2660 enema if they fail to respond to the first enema

Primary outcome: Efficacy, safety and tolerability of RBX2660 in subjects with recurrent CDI

Contacts:

PI: Christopher Holden, MD and David Kastenberg, MD
Coordinator: Angela Mozier
Angela.Mozier@Jefferson.edu
Phone: 215-503-4683

Crohn’s Disease - Patients intolerant to biologic therapy

Study title: A multicenter, randomized, double-blind, placebo-controlled induction study of the efficacy and safety of upadacitinib (ABT-494) in subjects with moderately to severely active Crohn's Disease who have inadequately responded to or are intolerant to biologic therapy

Study population: Moderate to severe Crohn’s disease

Sponsor: AbbVie

Overview: A multicenter study to evaluate the efficacy and safety of treatment with upadacitinib, an orally administered Janus kinase 1 inhibitor (JAK inhibitor), in adult patients with moderate to severe active Crohn's Disease who have inadequately responded to, or are intolerant to, biologic therapy

Primary outcome: To evaluate the efficacy and safety of upadacitinib for treating subjects with moderate to severe active Crohn's disease

Contacts:

PI: Raina Shivashankar, MD
Coordinator: Cindi Miller
Cynthia.L.Miller.3@Jefferson.edu
Phone: 215-955-8108

Crohn’s Disease - Patients who completed the M14-431 or M14-433 studies

Study title: A multicenter, randomized, double-blind, placebo controlled maintenance and long term extension study of the efficacy and safety of Upadacitinib (ABT-494) in subjects with Crohn’s Disease who completed the M14-431 or M14-433 studies

Study population: Moderate to severe Crohn’s disease

Sponsor: AbbVie

Overview: A multicenter study to evaluate the efficacy and safety of maintenance treatment with upadacitinib, an orally administered Janus kinase 1 inhibitor (JAK inhibitor), in adult patients with Crohn's disease

Primary outcome: To evaluate the efficacy and safety of two doses of upadacitinib maintenance therapy in subjects with moderate to severe active Crohn's disease who have responded to upadacitinib induction treatment

Contacts:

PI: Raina Shivashankar, MD
Coordinator: Cindy Miller
Cynthia.L.Miller.3@Jefferson.edu
Phone: 215-955-8108

Inflammatory Bowel Disease – Crohn’s and Ulcerative Colitis

Study title: The role of T cell homing ligand, C10orf99 in inflammatory bowel disease

Study population: Patients with Crohn’s disease and ulcerative colitis undergoing colonoscopy for an indication unrelated to this study

Sponsor: National Institutes of Health (NIH)

Overview: To examine whether, and to what degree, C10orf99 is present in the large intestine of healthy patients and those with inflammatory bowel disease

Primary outcome: To measure C10orf99 expression in health volunteers and subjects with inflammatory bowel disease

Contacts:

PI: David Kastenberg, MD
Coordinator: Cindi Miller
Cynthia.L.Miller.3@Jefferson.edu
Phone: 215-955-8108

Hepatology

Hepatitis B

Study title: A multi-center, open-label, long-term extension study of ABI-H0731 + Nucleos(t)ide as finite treatment for chronic hepatitis B patients

Study population: Chronic hepatitis B infection

Sponsor: Assembly Biosciences, Inc.

Overview: This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics of study agent ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir in participants with chronic hepatitis B virus infection

Primary outcomes:

  • 1.Tolerance/Adverse events and need to discontinue due to an adverse event
  • 2.Change from baseline in circulating hepatitis B DNA

Contacts:

PI: Hie-Won Hann, MD
Coordinator: Grace Park
Grace.Park@Jefferson.edu
Phone: 215-955-5806

Nonalcoholic Steatohepatitis (NASH)

Study Title: A seamless, adaptive, phase 2b/3, double-blind, Randomized, placebo-controlled, multicenter, international study evaluating the efficacy and safety of Belapectin (GR-MD-02) for the prevention of esophageal varices in NASH cirrhosis

Study Population: A total of approximately 525 subjects, including 315 subjects in Phase 2b (Stage 1) and 210 subjects in Phase 3 (Stage 2), will be enrolled in approximately 130 study centers in the US, Europe, and other international locations. Inclusion criteria: Evidence of portal hypertension with at least 2 of the following: a. platelet count <150,000/mm3 b. spleen size ≥ 15 cm (by documented MRI, CT scan, or ultrasound imaging) c. collateral vessels (by documented MRI or ultrasound imaging or physical examination, i.e., caput medusae). Has a history confirming NASH cirrhosis

Sponsor: Galectin Therapeutics Inc.

Overview: In this seamless, adaptive, two-stage Phase 2b/3 trial in patients with NASH cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline, an interim analysis (IA) will occur during Stage 1 of this trial (Phase 2b, after 78 weeks [18 months] of treatment), and then following any adaptive modifications based on that IA, the trial will continue seamlessly into Stage 2 (Phase 3, with 78 weeks [18 months] of treatment).

Primary Outcome: (1) To evaluate the efficacy of 2 mg/kg and 4 mg/kg lean body mass (LBM) of belapectin (GR MD-02) compared to placebo in preventing the development of esophageal varices. (2) To evaluate the effect of belapectin on composite clinical outcomes. (3) To evaluate the effect of belapectin on progression of esophageal varices. (4) To evaluate the effect of belapectin treatment on liver cirrhosis-related clinical events.

Contacts:

PI: Dina Halegoua-Demarzio, MD
Dina.Halegoua-DeMarzio@jefferson.edu
Coordinator: Cindi Miller
Cynthia.L.Miller.3@Jefferson.edu
Phone: 215-955-8108

Nonalcoholic Steatohepatitis (NASH)

Study title: A phase 3/4, multinational, multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Aramchol in subjects with nonalcoholic steatohepatitis (NASH)

Study population: NASH with fibrosis stage 2-3

Sponsor: Galmed

Overview: Subjects with NASH and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes will be randomized to study drug Aramchol, or placebo

Primary objective: To evaluate the effect of Aramchol on NASH resolution, fibrosis improvement, and clinical outcomes related to progression of liver disease

Contacts:

PI: Dina Halegoua-Demarzio, MD
Dina.Halegoua-DeMarzio@jefferson.edu
Coordinator: Angela Mozier
Angela.Mozier@Jefferson.edu
Phone: 215-503-4683

Nonalcoholic Steatohepatitis (NASH)

Study title: A phase 2B, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of VK2809 administered for 52 weeks followed by a 4-week off-drug phase in subjects with biopsy proven NASH with fibrosis

Study population: Patients with NASH

Sponsor: Viking Therapeutics

Overview: To evaluate the effects of VK2809 on liver fat content as measured by MRI 

Primary objective: To assess whether a 12-week course of VK2809 results in a significant reduction in liver fat content as compared to placebo in patients with NASH

Contacts:

PI: Dina Halegoua-DeMarzio, MD
Dina.Halegoua-DeMarzio@jefferson.edu
Coordinator: Michael Matthews
Michael.Matthews@Jefferson.edu
Phone: 215-503-2545

Nonalcoholic Steatohepatitis (NASH)

Study Title: A phase 2, randomized, double-blind, double-dummy, placebo controlled, dose-ranging, dose-finding, parallel group study to assess efficacy and safety of PF-06865571 (DGAT2I) alone and when co-administered with PF-05221304 (ACCI) in adult participants with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis stage 2 or 3

Study Population: Inclusion Criteria: Body Mass Index > 25 kg/m2, body weight > 50 kg, liver fat (assessed via MRI-PDFF) > 8%, biopsy-proven NASH diagnosed within previous 24-months, presumed NASH - per Sponsor's definition, NAFLD with minimal inflammation/fibrosis, features of metabolic syndrome

Sponsor: Pfizer

Overview: The current study is the first clinical trial specifically designed to evaluate the effect of two, orally administered, investigational agents – DGAT2i alone, administered once or twice daily, and DGAT2i + ACCi administered twice daily – on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy). These will be compared to placebo.

Additionally, exploratory assessment of non-invasive imaging-based and blood-based collections are planned to enable potential identification of non-invasive markers of disease and/or treatment response in the target adult population.

Primary Outcome: Percent change from baseline in liver fat by MRI-Proton Density Fat Fraction (MRI- PDFF) at week 16 [time frame: Baseline (between day 14 and day 1), week 16]

Contacts:

PI: Dina Halegoua-Demarzio, MD
Dina.Halegoua-DeMarzio@jefferson.edu
Coordinator: Cindi Miller
Cynthia.L.Miller.3@Jefferson.edu
Phone: 215-955-8108

Primary Sclerosing Cholangitis (PSC)

Study title:A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of cilofexor in non-cirrhotic subjects with PSC

Study population: Non-cirrhotic patients with PSC

Sponsor: Gilead

Overview: PSC patients without cirrhosis will be randomized to the study agent, cilofexor, or to placebo and liver fibrosis assessments will be performed

Primary objective: To evaluate whether cilofexor reduces the progression of liver fibrosis

Contacts:

PI: Jonathan Fenkel, MD
Coordinator: Mike Matthews
Michael.Matthews@Jefferson.edu
Phone: 215-503-2545

Porphyria

Study title: A phase 3, global, multicenter, randomized, double-blind, placebo-controlled study to evaluate efficacy, safety, and tolerability of MT-7117 in subjects with erythropoietic protoporphyria or X-Linked protoporphyria

Study population: Patients with erythropoetic protoporphyria, age 12-75

Sponsor: Mitsubishi

Overview: Subjects with erythropoetic protoporphyria will be randomized to study agent, MT-7117, or placebo with the goal of evaluating this medication’s effectiveness, safety, and tolerability

Primary objective: To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, or stinging) associated with sunlight exposure in subjects with erythropoetic protoporphyria

Contacts:

PI: Manish Thapar, MD
Coordinator: Mike Matthews
Michael.Matthews@Jefferson.edu
Phone: 215-503-2545

Primary Biliary Cholangitis

Study title: A double-blind, randomized, placebo-controlled study and open-label long term extension to evaluate the efficacy and safety of Elafibranor 80 mg in patients with PBC with inadequate response or intolerance to ursodeoxycholic acid (UCDA)

Study population: Patients with PBC and inadequate response or intolerance to UDCA

Sponsor: GENFIT

Overview: This is a phase 3 double-blind, randomized, placebo-controlled study with an open-label long term extension evaluating the efficacy and safety of Elafibranor 80 mg once daily versus placebo in patients with PBC and inadequate response or intolerance to UCDA

Primary objective: To evaluate the effect of Elafibranor (80 mg/day) on cholestasis as defined by the primary endpoint over 52 weeks of treatment compared to placebo

Contacts:

PI: David Sass, MD
Coordinator: Cindi Miller
Cynthia.L.Miller.3@Jefferson.edu
Phone: 215-955-8108