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Gastrointestinal Research Center

Current Clinical Trials

The Division conducts a number of clinical trials in various of aspects of digestive and liver diseases. For more information on any of these trials, please contact Cynthia Miller, RN at 215-955.8108.

Gastroenterology Trials

Incomplete Capsule Endoscopy in an Inpatient Population
PI: Mitchell Conn, MD

A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects during a Gluten Challenge.  (CLIN1001-006 /Amendment 01)
PI: Anthony J DiMarino, Jr, MD

A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Study for the Treatment of Active Celiac Disease with AT-1001
PI: Anthony J DiMarino, Jr, MD

A Prospective, Multi-Center, Longitudinal Cohort Study of Cryo Spray AblationTM of Low Grade or High Grade Dysplasia within Barrett’s Esophagus (LCS Dysplasia)
PI: Anthony Infantolino, MD

Evaluation of Capsule Endoscopy in Patients with Suspected Crohn’s Disease.
PI: Anthony Infantolino, MD

Procurement of serum samples from microscopic colitis subjects
PI: David Kastenberg, MD

Efficacy of a low volume PEG purgative (MoviPrep®) administered entirely in the morning compared to split dose (PM/AM) administration.
PI: David Kastenberg, MD

Efficacy of low volume polyethylene glycol (MoviPrep) plus simethicone (PEG-s) as a small bowel purgatie prior to capsule endoscopy
PI: David Kastenberg, MD

Comparison of MiroCam Capsule Endoscope with PillCam SB2 Capsule Endoscope in
Small Bowel Disease
PI: David Kastenberg, MD

A 5-Year Registry Study of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn’s Disease (DC).
PI: David Kastenberg, MD

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis
PI: Patricia Kozuch, MD

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis
PI: Patricia Kozuch, MD

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
PI: Patricia Kozuch, MD

A Phase 2B, Multi-center, Randomized, Double − blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT − 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease.   Kozuch
PI: Patricia Kozuch, MD

Hepatology Trials

A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated with Adefovir Dipivoxil for Chronic Hepatitis B and having Persistent Viral Replication
PI: Hie-Won Hann, MD

A Single Center Open-label, Randomized Study Comparing the Safety of Immediately Switching from Lamivudine to Adefovir Dipivoxil Versus Overlapping Lamivudine and Adefovir for 12 Weeks Before Instituting Adefovir Dipivoxil Monotherapy in Patients with Chronic Hepatitis B Patients (Investigator-initiated phase 4 study).
PI: Hie-Won Hann, MD

Randomized, Open-Label, Comparative Study to Evaluate Early Viral Load Reductions and Exploratory Viral Kinetics Following Administration of Entecavir or Adefovir in Nucleoside-Naïve Adults with Chronic Hepatitis B Infection  
PI: Hie-Won Hann, MD

Comparison of PEG-Intron® 1.5 mg/kg/wk Plus REBETOL® vs PEG-Intron® 1 mg/kg/wk Plus REBETOL® vs PEGASYS® 180 mg/wk Plus COPEGUS® in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected with Genotype 1.
PI: Steven K. Herrine, MD

Randomized, Multicenter, Double-Blinded, Phase IV Study Evaluating the Efficacy (as measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys in Combination with Higher Copegus Doses in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater than or Equal to 85 kg.
PI: Steven K. Herrine, MD

P03523-A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects with Chronic Hepatitis C Infected with Genotype 1.
PI: Steven K. Herrine, MD

Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected with Hepatitis B Virus and Evidence of Hepatic Decompensation.
PI: Simona Rossi, MD

A Prospective, Multicenter, Open-Label, Comparative, Efficacy Study of Pegasys® plus Copegus®  in Treatment-Naïve Latino Patients with Chronic Hepatitis C-Genotype 1, as Compared to Treatment-Naïve Non-Latino Caucasian Patients with Chronic Hepatitis C-Genotype 1.
PI: Victor J. Navarro, MD

Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus- AI463109
PI: Victor J. Navarro, MD

A Multicenter, Randomized, Double Masked, Placebo Controlled Phase II Study to Assess the Safety and Efficacy of a Standardized Orally Administered Silymarin Preparation (Legalon®) for the Treatment of Non-Cirrhotic Patients with Non-Alcoholic Steatohepatitis (NASH) (IND 74,887) 
PI: Victor J. Navarro, MD

A Multi-Center, Randomized, Double Masked, Placebo Controlled Phase II Study to Assess the Safety and Efficacy of a Standardized Orally Administered Silymarin Preparation (Legalon®) for the Treatment of Non-Cirrhotic Patients
PI: Victor J. Navarro, MD