Current Clinical Trials

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.

Barretts Esophagus/Metformin Study
Contact: Maureen DeMarshall 215-349-8546 Email

A randomized, double-blind, placebo controlled phase II trial of Barrett's Esophagus chemoprevention with Metaformin.

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: Alan Herbst 215-349-8563

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

IRB # 700135: The Crohn's Therapy, Resource Evaluation and Asseessment Tool (TREAT). This study has officially ended by instruction of the sponsor; however, we have not yet completed close-out procedures.

IRB #811262: Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study (CZP4UC)

IRB #812214: 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 (MERIT-UC)

IRB # 806902: in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO)

IRB #802121: Mid-Atlantic African American Inflammatory Bowel Disease Study (MAAAIS): The Search for New Genes. This study is also pending closure.

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.

EOSINOPHILIC ESOPHAGITIS

Meritage MPI-101-06
Contact: Maureen DeMarshall 215-349-8546  Email

A Phase II, Randomized, Double-blind, Placebo controlled study with an open-label extention of Oral Budesonide (OBS) in adolescent and young adult subjects with Eosinophilic Esophagitis.

BARRETT'S ESOPHAGUS

BETRNet Notch Signaling
Contact: Maureen DeMarshall 215-349-8546 Email

Biomedical research to identifying new molecular markers in the tissue of Barretts Esophagus.

BETRNet Recurrence after RFA
Contact: Maureen DeMarshall 215-349-8546 Email

Biomedical research to identify biomarkers of non-response to therapy and of recurrent intestinal metaplasia after successful eradication.

Familial Barrett's Esophagus
Contact: Maureen DeMarshall 215-349-8546 Email

Biomedical research to identify factors, including genes that contribute to the development of Barrett's Esophagus & esophageal cancer in families.

BE Tissue Collection
Contact:  Maureen DeMarshall 215-349-8546  Email

Cell culture from GERD and Barrett's Esophagus