Current Clinical Trials
SyNCH II (NASH)
Contact:
Amina Wirjosemito 215-615-547 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
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.
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
BMS AI444-40
Contact: Grace Kim-Lee 215-898-3981 email
A Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of PSI-7977 in Combination with BMS-790052 with or without
Ribavirin in Treatment Naive Subjects Chronically Infected with Hepatitis C Virus
Genotypes 1, 2, or 3.
Early TIPS
Contact: Michael Iskoe 215-615-3755
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.
Sorafenib
Contact: Michael Iskoe 215-615-3755
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
REVERSE
Contact: Michael Iskoe 215-615-3755
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)
Infections in Cirrhosis
Contact: Aaron Blouin 215-349-8507
Observational study for in patients presenting with comorbid and secondary infections.
VX11-950-116
Contact: Aaron Blouin 215-349-8507
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
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.
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study
Contact: Aaron Blouin 215-349-8507
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.
A Phase 2 Randomized, Double-Blind, Placebo-controlled Study
Contact: Aaron Blouin 215-349-8507
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.
Merck
Contact: Aaron Blouin 215-349-8507
A dose-ranging study to test the safety, tolerability and effectiveness of different doses of MK-5172 when given with Peginterferon alfa-2b and Ribavirin in patients with Hepatitis C Virus Infection.
TMC435HPC3001
Contact: Grace Kim-Lee 215-898-3981
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-1infected subjects who were null or partial responders to prior PegIFNa and Ribavirin therapy.
AI447-028
Contact: Grace Kim-Lee 215-898-3981
Entitled, A Phase 3, Open-Label Study with BMS-790052 and BMS-650032 (DUAL) for null-/partial responders to PegInterferon Alfa-2a and Ribavirin (P/R) therapy and PegInterferon Alfa-2a and Ribavirin ineligible-naive/tolerant subjects with chronic hepatitis C, Genotype 1b.
AI447-029
Contact: Grace Kim-Lee 215-898-3981
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.
Quantum Phase 2
Contact: Amina Wirjosemito 215-615-5471
Expected enrollment oct/Nov, twelve patients at Penn: Treatment Naive HCV Genotype 1 patients only. 24 weeks of Ribavirin treatment alone or in combination with two novel drug compounds. A cyclic phosphate prodrug P2938-0212, and a phosphoramidate prodrug PSI-7977. This study is appealing in that it offers patients an all-oral alternative to Pegylated-interferon alfa treatments.
Eosinophilic Esophagitis / Aptalis Study:
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)
Barretts Esophagus / Metformin Study
A randomized, double-blind, placebo controlled phase II trial of Barrett's Esophagus chemoprevention with Metaformin.