Thomas Jefferson University
Sidney Kimmel Medical College
Department of Medicine

Research Activity

Current 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.

Gastroenterology Trials

Celiac Disease

  1. Study: Evaluate for blood, stool, and urine markers of gluten ingestion, and for gastrointestinal symptoms, in non-celiac gluten sensitive (NCGS) patients who eat gluten.  
    Purpose: Enhance the understanding of laboratory markers of gluten ingestion found in blood, stool, and urine, as well as gastrointestinal symptoms, present after non-celiac gluten sensitive (NCGS) patients eat gluten.   
    Keywords: Gluten sensitivity, gluten, markers, non-celiac gluten sensitivity, symptom
    Investigators: Anthony DiMarino, MD, and Stephanie Moleski, MD
    Study Coordinator: Irene Dialino, 215-503-4683
  2. Study: Evaluate for blood and stool markers of gluten ingestion in celiac disease patients who follow a gluten free diet for at least 12 months.
    Purpose: Enhance the understanding of laboratory markers of gluten ingestion in blood, urine and stool in celiac disease patients on a gluten free diet by comparing markers to baseline values.
    Keywords: Celiac disease, gluten, markers
    Investigators: Anthony DiMarino, MD, and Stephanie Moleski, MD, stephanie.moleski@jefferson.edu
    Study Coordinator: Irene Dialino, 215-503-4683

Colon Cancer: Prevention

  1. Study: A vaccine (MUC 1) for patients at increased risk for colon polyps.
    Purpose: To assess a) whether patients respond to vaccine targeted at a cell protein that is abnormal (MUC1) in polyps, and b) whether the vaccine decreases the chance for future polyps in those who have had a high-risk (large or abnormal features) polyp within the past year.
    Keywords: MUC1, polyp, prevention, vaccine
    Investigator: David Kastenberg, MD
    Study Coordinator: Irene Dialino, 215-503-4683

Gastrointestinal Disorders

Crohn’s Disease

  1. Study: To better understand treatment for Crohn’s disease from a patient’s experience.
    Purpose: The purpose of the study is to learn about treatment for Crohn’s disease from the patient’s perspective – how treatment is chosen, how long a chosen treatment is followed, how much the treatment costs, and how well the treatment works.
    Keywords: Crohn’s disease, decision, patient, treatment
    Investigator: Patricia Kozuch, MD;
    Study Coordinator: Irene Dialino; 215-503-4683

Endoscopy: Bile duct cancer (cholangiocarcinoma)

  1. Study: Evaluate whether photodynamic therapy (PDT) is helpful and safe for treating bile duct cancer.
    Purpose: To evaluate the safety and effectiveness of photodynamic therapy (PDT) in the treatment of inoperable bile duct cancer. This study uses porfimer sodium, a light sensitizer, which is first administered intravenously and taken up by cancer cells in the bile duct. Endoscopically, a laser is placed into the bile duct and emits light that activates porfimer sodium and destroys cancer cells while limiting damage to surrounding healthy tissue.
    Keywords: Bile duct cancer, cholangiocarcinoma, treatment, PDT, photodynamic therapy, porfimer sodium
    Investigator: David Loren, MD
    Study Coordinator: Cynthia Miller, RN; 215-955-8108

Endoscopy: Esophagus

  1. Study: To evaluate the process of intentionally removing a covered stent from the esophagus.  
    Purpose: To evaluate the process of removing the Evolution Esophageal Fully Covered Stent, a flexible metal (nitinol) tube covered with a thin layer of silicone, from the esophagus in patients who had the stent placed to cover a hole or widen a narrowing.
    Keywords: Esophagus, removal, stent
    Investigator: Thomas Kowalski, MD
    Coordinator: Irene Dialino; 215-503-4683

Motility

  1. Study: To evaluate whether a protein found in the blood causes gastrointestinal problems commonly seen in patients with scleroderma.
    Purpose:  Test if there is a small protein in the blood of scleroderma patients that causes changes in the large intestine and rectum resulting in impaired function of the anal sphincter muscles.
    Keywords: Anal sphincter, blood test, scleroderma
    Investigator: Sidney Cohen, MD
    Study Coordinator: Irene Dialino 215-503-4683

Upcoming studies (not yet enrolling):

Capsule colonoscopy: Colon cancer screening
Investigator: David Kastenberg, MD
Clinical Coordinator: Irene Dialino; 215-503-4683

Achalasia: New medication
Investigator: Sidney Cohen, MDx

Crohn’s Disease: A new class of medication
Investigator: Leo Katz, MD

Hepatology Trials

Fatty Liver Disease (NASH or Nonalcoholic steatohepatitis)- Hepatology

  1. Study: To evaluate a new medication (BMS-986036) for NASH.
    Purpose:  Look at how the investigational medication BMS-986036 affects patients with NASH: Safety, how the medicine affects patients, and how the patients metabolize (break down) the medication.
    Keywords: NASH, steatohepatitis, treatment
    Investigator: Dina Halegoua-DeMarzio, MD
    Study coordinator: Cynthia Miller, RN, 215-955-8108
  2. Study: To evaluate a new medication for the treatment of cirrhosis (scarring of the liver) due to NASH.
    Purpose: NASH is a chronic inflammatory disease of the liver that may cause cirrhosis and related complications. This study is to determine if a new medication (GR-MD-02) reverses liver scarring and is safe.
    Keywords: Cirrhosis, NASH, nonalcoholic steatohepatitis, treatment,
    Investigator: Dina Halegoua-DeMarzio, MD
    Study Coordinator: Cynthia Miller, RN, 215-955-8108
  3. Study: To evaluate whether a new medication is safe and effective for treating NASH.
    Purpose: Study the effect of an investigational medication, obeticholic acid (a modified bile acid), on NASH.
    Keywords: NASH, nonalcoholic steatohepatitis, obeticholic acid, treatment
    Investigator: Dina Halegoua-DeMarzio, MD
    Study Coordinator: Hannah Ott, RN, 215-955-7979
     
  4. Study: To evaluate whether a new medication in combination with medicine for lowering cholesterol (Atorvastatin) is effective for treating patients with NASH.
    Purpose: Study the safety and effectiveness of obeticholic acid together with the cholesterol lowering medicine atorvastatin (Lipitor®) on LDL cholesterol metabolism in patients with NASH and liver fibrosis.
    Keywords: NASH, nonalcoholic steatohepatitis, obeticholic acid, treatment
    Investigator: Dina Halegoua-DeMarzio, MD
    Study Coordinator: Hannah Ott, RN, 215-955-7979

Liver Disorders

Cirrhosis: Portal hypertension

  1. Study: In patients with cirrhosis, to evaluate whether a new ultrasound test accurately measures pressures in the veins (portal veins) bringing blood to the liver. 
    Purpose: Determine if the combination of a new ultrasound technique (subharmonic-aided pressure estimation or SHAPE), combined with an ultrasound contrast agent (Sonazoid), can accurately assess for portal hypertension (high pressure in the veins bringing blood to the liver – portal vein). This study is for patients in whom a transjugular liver biopsy (procedure through the jugular vein to perform a liver biopsy) is planned.
    Key words: Cirrhosis, portal hypertension, transjugular liver biopsy, ultrasound
    Investigator:Flemming Forsberg, PhD and Jonathan Fenkel, MD
    Study Coordinators: Cynthia Miller, RN; 215-955-8108 or Hannah Ott, RN; 215-955-7979

Hepatitis B

  1. Study: To compare the effectiveness of two medications for treating chronic hepatitis B.
    Purpose: To evaluate the safety and effectiveness of tenofovir alafenamide (TAF) (new medication) to tenofovir disoproxil fumarate (TDF) (approved for treating hepatitis B) for treatment of hepatitis B.
    Keywords: Hepatitis B, tenofovir alafenamide, tenofovir disoproxil fumarate
    Investigator: Hie-Won Hann, MD
    Study Coordinator: Grace Park; 215-955-5806

Hepatitis C

  1. Study: To understand how doctors take care of patients with hepatitis C.
    Purpose: Collect and study information on patients with chronic hepatitis C virus (HCV) who are undergoing treatment for HCV. Find out how different HCV treatments are being used, the side effects, benefits, optimal duration, genetic variations, drug interactions, resistance, etc.
    Key words: Hepatitis C, treatment
    Investigator: Jonathan Fenkel, MD
    Study Coordinator: Irene Dialino; 215-503-4683

Hepatic encephalopathy (confusion from liver disease)

  1. Study: To evaluate a new medication (OCR-002) for treating hospitalized patients with cirrhosis who have hepatic encephalopathy. 
    Purpose: This study is for hospitalized patients with cirrhosis and hepatic encephalopathy. The study medication (OCR-002) aims to lower blood ammonia levels (implicated in causing confusion) and evaluate whether patients recover more quickly.
    Keywords: Ammonia, cirrhosis, hepatic encephalopathy, hospital, OCR-002
    Investigator: David Sass, MD
    Study Coordinators: Cynthia Miller, RN; 215-955-8108 or Hannah Ott, RN; 215-955-7979 

Liver cancer (hepatocellular carcinoma): Early detection

  1. Study: A new blood test to detect liver cancer (hepatocellular cancer)
    Purpose: Evaluate a new laboratory test to diagnose liver cancer at an early stage. 
    Keywords: Diagnosis, hepatocellular carcinoma, liver cancer
    Investigator: Jesse Civan, MD
    Study coordinator: Irene Dialino; 215-503-4683
  1. Study: Detection of hepatitis B DNA in urine.
    Purpose: To determine if detecting a form of hepatitis B DNA in the urine can aide in the early detection of hepatitis B related liver cancer.
    Keywords: DNA, Hepatitis B, hepatocellular carcinoma, urine
    Investigator: Hie-Won Hann, MD
    Study Coordinator: Grace Park; 215-955-5806
    1. Study: To evaluate whether ultrasound can accurately assess response to treatment in patients with liver cancer (hepatocellular carcinoma) who have undergone trans-arterial chemoembolization (TACE). Purpose: This study is for patients with liver cancer (hepatocellular carcinoma) who are being treated with trans-arterial chemoembolization (TACE). The purpose is to evaluate whether ultrasound with contrast is effective in monitoring the response to treatment with TACE. 
      Key words: Hepatocellular carcinoma, liver cancer, TACE, transarterial chemoembolization, ultrasound
      Investigators: John Eisenbrey, PhD and Jesse Civan, MD
      Coordinators: Cynthia Miller, RN; 215-955-8108 and Hannah Ott, RN; 215-955-7979
  2. Liver cancer (hepatocellular carcinoma): Treatment

  1. Study: To evaluate whether ultrasound can accurately assess response to treatment in patients with liver cancer (hepatocellular carcinoma) who have undergone trans-arterial chemoembolization (TACE). Purpose: This study is for patients with liver cancer (hepatocellular carcinoma) who are being treated with trans-arterial chemoembolization (TACE). The purpose is to evaluate whether ultrasound with contrast is effective in monitoring the response to treatment with TACE. 
    Key words: Hepatocellular carcinoma, liver cancer, TACE, transarterial chemoembolization, ultrasound
    Investigators: John Eisenbrey, PhD and Jesse Civan, MD
    Coordinators: Cynthia Miller, RN; 215-955-8108 and Hannah Ott, RN; 215-955-7979

Upcoming studies (not yet enrolling):

NASH cirrhosis: New medication
Investigator: Jonathan Fenkel, MD
Clinical Coordinator: Cynthia Miller, RN; 215-955-8108