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Current Clinical Trials

FOR PATIENTS AND PHYSICIAN REFERRALS

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Barrett's Esophagus

Eosinophilic Esophagitis

Hepatology

Inflammatory Bowel Disease

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BARRETT'S ESOPHAGUS
For all studies contact: Maureen DeMarshall 215-349-8546  Email

Wide Area Transepithelial Sample 3-Dimensional Esophageal Biopsy (WATS) combined with computer assisted analylsis for the Detection of Esophageal Dysplasia:  A Prospective, Randomized, Tandem Study:

The purpose of this study is to see if the addition of a brush biopsy to standard, forceps biopsy improves the detection of precancerous changes in the esophagus (food pipe) in people with Barrett's esophagus.  Barrett's esophagus is a change in the normal lining of the esophagus due to chronic acid reflux.  Funds for conducting this research are provided by CDx Diagnostics, the company that developed the brush biopsy instrument.

Notch Signaling and Novel Biomarkers for Barrett's Esophagus - BETRNet funded study

Prospective cohort study of patients with BE, with or without associated dysplasia or adenocarcinoma, and controls with and without GERD

This study hopes to identify new molecular markers in the tissue of Barrett's esophagus that will help physicians better understand and manage this condition. The investigators hope to use the information from this study to identify new molecular markers to better determine who will or will not go on to develop esophageal cancer. Patients who have been diagnosed in the past with Barrett's esophagus will be asked to participate. Patients without Barrett's esophagus will be asked to take part so that the investigators can compare tissue from patients without the conditions to those with the conditions.

Inclusion/Exclusion Criteria

Radiofrequency Ablation and Barrett's Esophagus - BETRNet funded study

The overall goals of the two aims are to identify biomarkers of non-response to therapy and of recurrent intestinal metaplasia after successful eradication.

This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for cancer progression as well as of response to ablation therapy. These results will result in improved risk stratification in Barrett’s esophagus and allow for better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.

Inclusion/Exclusion Criteria

Familial Barrett's Esophagus - BETRNet funded study

A collaborative multi-center study evaluating the genetic and environmental determinants of Barrett’s esophagus and esophageal adenocarcinoma.

The aim is to define the epidemiology and genetics of Barrett’s esophagus and esophageal cancer in families affected with Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus and esophageal cancer occur at a younger age in these families suggesting that familial Barrett’s esophagus is a genetically inherited disease.

Inclusion/Exclusion Criteria

BE Tissue Collection

Cell culture from GERD and Barrett's Esophagus

HEPATOLOGY

Abbott Pearl-I M13-393
Contact: Amina Wirjosemito 215-615-5471 Email

A randomized, Open-Label Study to evaluate the safety and efficacy of Coadministration of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in adults with chronic Hepatitis C Virus Infection.

Acute Liver Failure
Contact: Amina Wirjosemito 215-615-5471 Email

A multi center group to study acute liver failure

Acute Liver Injury
Contact: Amina Wirjosemito 215-615-5471 Email

A multi center group to study acute liver failure

AI447-029
Contact: Grace Kim-Lee 215-898-3981  Email

Entitled, Phase 3, Open-Label Study with BMS-790052 and BMS-650032 Plus Peginterferon Alfa-2a and Ribavirin (P/R) (QUAD) for subjects who are null/partial responders to P/R with chronic hepatitis C, Genotype 1a/1b.

BMS AI444-26
Contact: Grace Kim-Lee 215-898-3981 Email

An Open-Label re-treatment study with Peg-Interferon Alfa-2A, Ribavirin and BMS-790052 with or without BMS-650032 for subjects with chronic Hepatitis C.

DILIN (Prospective arm)
Contact: Amina Wirjosemito 215-615-5471 Email

Continuation and expansion of the drug induced liver injury network for patients who have suffered liver injury from drugs or complimentary and alternative medicines in the past 6 months.

DILIN (Retrospective arm)
Contact: Amina Wirjosemito 215-615-5471 Email

Continuation and expansion of the drug induced liver injury network for patients who have suffered liver injury from isoniazid (INH), phenytoin (Dilantin), combination clavulanic acid/amoxicillin (Augmentin), and valproic acid (Depakote), Nitrofurantoin, Trimethoprim-sulfamethoxazole, Minocycline, and Quinolone antibiotics since January 1, 1994.

Early TIPS
Contact: Michael Iskoe 215-615-3755 Email

The GORE® VIATORR® TIPS Endoprosthesis versus Large-Volume Paracentesis for the Treatment of Ascites in Patients with Portal Hypertension: A prospective, multi-center, randomized comparison of GORE® VIATORR® TIPS Endoprosthesis to Large Volume Paracentesis (LVP) for the treatment of difficult to treat ascites.

Eosinophilic Esophagitis/Aptalis Study
Contact: Maureen DeMarshall 215-349-8546 Email

A multicenter, randomized, double-blind, placebo-controlled, safety and tolerability phase 1/2a study of two dosing regimens of EUR-1100 for oral use, in subjects with eosinophilic esophagitis (EOE).  No longer enrolling new subjects.

Epidemiological Study:  VOCAL (Veteran's Outcomes from Cancer and LIver Disease)

Gilead 107
Contact: Aaron Blouin 215-349-8507 Email

GS-7977 or Placebo plus Ribavirin or Placebo for 12 weeks in treatment naïve patients with Genotype 2/3 Hepatitis C viral infections.  Not presently enrolling new subjects.

Gilead 108
Contact: Aaron Blouin 215-349-8507 Email

GS-7977 plus Ribavirin for 12 weeks or 16 weeks in treatment experienced patients with Genotype 2/3 Hepatitis C viral infections.  Not presently enrolling new subjects.

Gilead 109
Contact: Aaron Blouin 215-349-8507 Email

GS-7977 plus Ribavirin for 12 weeks for subjects who have previously enrolled in a 7977 study.  Enrolling August, 2012.

Gilead 110
Contact: Aaron Blouin 215-349-8507 Email

GS-7977, Pegylated interferon, plus Ribavirin for 12 weeks in treatment naïve patients with Genotype 1, 4, 5, or 6 Hepatitis C viral infections.  Not presently enrolling new subjects.

Gilead 122
Contact: Aaron Blouin 215-349-8507 Email

A follow-up observational study for previous Gilead study patients who have experienced a sustained virologic responde to therapy.  On-going enrollment limited to prior participation.

Gilead 123
Contact: Aaron Blouin 215-349-8507 Email

A follow-up observational study for previous Gilead study patients who have not experienced a sustained virologic response to therapy.  On-going enrollment limited to prior participation.

Gilead 131
Contact: Aaron Blouin 215-349-8507  Email

GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) compared with GS-5885, GS-9451 with Tegobuvir or RBV in treatment-experienced subjects with chronic genotype 1a or 1b Hepatitis C virus (HCV) Infection.  Not presently enrolling new subjects.

Gilead 132
Contact: Aaron Blouin 215-349-8507  Email

GS-5885, GS-9451, Tegobuvir and Ribavirin: GS-5885, GS-9451 and Tegobuvir: GS-5885, GS-9451 and Ribavirin in Interferon ineligible or intolerant subjects with chronic genotype 1a or 1b HCV infection.  Not presently enrolling new subjects.

Infections in Cirrhosis
Contact: Yifei Mu 215-615-3755 Email

Observational study for in patients presenting with comorbid and secondary infections.

REVERSE
Contact: Michael Iskoe 215-615-3755  Email

A Phase 3, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (REVERSE Trial)

SyNCH II (NASH)
Contact: Amina Wirjosemito 215-615-5471 Email         
    
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 with Non-Alcoholic Steatohepatitis

Sorafenib
Contact: Michael Iskoe 215-615-3755 Email  

A Multi-Center, Placebo-Controlled, Randomized Pilot Study of the Effect of Sorafenib on Portal Pressure in Patients with Cirrhosis, Significant Portal Hypertension and Hepatocellular Carcinoma Treated with Ablative Therapy and/or Transarterial Chemoembolization.

TMC435HPC3001
Contact: Grace Kim-Lee 215-898-3981  Email

A phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFNa-2a and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null or partial responders to prior PegIFNa and Ribavirin therapy.

VX11-950-116
Contact: Michael Iskoe 215-615-3755  Email

An Open-Label, Phase 4 study of Telaprevir, Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in treatment-experiences Black/African American and Non-Black/African American Subjects with Genotype 1 Chronic Hepatitis C who have not achieved a sustained viral response with a prior course of Interferon-based Therapy.

VX11-950-117
Contact: Aaron Blouin 215-349-8507  Email

A 2-part, Open-Label study of Telaprevir in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in subjects chronically infected with Genotype 1 Hepatitis C Virus following a liver transplantation.  Enrolling September, 2012.

INFLAMMATORY BOWEL DISEASE
For all studies contact: Susan Parrott 215-662-8919 Email

CZP4UC

Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study

MERIT-UC

Randomized, double blind, prospective trial investigating the efficacy of methotrexate in induction and maintenance of steroid free remission in ulcerative colitis (Methotrexate Response In Treatment of UC)

PIANO

Inflammatory Bowel Disease and Neonatal Outcomes

I3:  IBD IMMUNOLOGY INITIATIVE
Contact:  Research Coordinator, 215-898-0161, I3Study@uphs.upenn.edu

A translational clinical and tissue database study.

Actively enrolling all Crohn's disease and Ulcerative Colitis patients seen within the University of Pennsylvania Health System.  The aim is to understand abnormalities in the immune system and other factors that impact IBD.

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University of Pennsylvania | Perelman School of Medicine