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.

Learn more about registered studies by visiting clinicaltrials.gov.

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
    Learn more: go to ClinicalTrials.gov and enter study number NCT02389062
    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
    Learn more: go to ClinicalTrials.gov and enter study number NCT02389062
    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
    Learn more: go to ClinicalTrials.gov and enter study number NCT02134925
    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
    Learn more: go to ClinicalTrials.gov and enter study number NCT02082522
    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
    Learn more: go to ClinicalTrials.gov and enter study number NCT01900691
    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/Liver Disorders Trials

Fatty Liver Disease (NASH or nonalcoholic steatohepatitis)

  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
    Learn more: go to ClinicalTrials.gov and enter study number NCT02413372
    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,
    Learn more: go to ClinicalTrials.gov and enter study number NCT02462967
    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
    Learn more: go to ClinicalTrials.gov and enter study number NCT02548351
    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
    Learn more: go to ClinicalTrials.gov and enter study number NCT02633956
    Investigator: Dina Halegoua-DeMarzio, MD
    Study Coordinator: Hannah Ott, RN, 215-955-7979

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
Learn more: go to ClinicalTrials.gov and enter study number NCT02489045
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
2. 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
Learn more: go to ClinicalTrials.gov and enter study number NCT01940471  
Investigator: Hie-Won Hann, MD
Study Coordinator: Grace Park; 215-955-5806

Hepatitis C

3. 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.
    Keywords: Hepatitis C, treatment
   Learn more: go to ClinicalTrials.gov and enter study number NCT01474811    Investigator: Jonathan Fenkel, MD
    Study Coordinator: Irene Dialino; 215-503-4683

Hepatic encephalopathy (confusion from liver disease)

4. 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
Learn more: go to ClinicalTrials.gov and enter study number NCT01966419
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

5. 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

6. 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

7. 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

Liver cancer (hepatocellular carcinoma): Treatment

8. 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
Learn more: go to ClinicalTrials.gov and enter study number NCT02764801
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):

Capsule colonoscopy: Colon cancer screening
Investigator: David Kastenberg, MD; david.kastenberg@jefferson.edu
Clinical Coordinator: Irene Dialino; irene.dialino@jefferson.edu, 215-503-4683

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

Achalasia: New medication
Investigator: Sidney Cohen, MD; sidney.cohen@jefferson.edu

Crohn's Disease: A new class of medication
Investigator: Leo Katz, MD; leo.katz@jefferson.edu