Site Principal Investigator
Andrew de la Torre MD

New Jersey Medical School

Efficacy and Safety Study of PEG-Interferon (IFN) Lambda (PEG-rIL-29) Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection (EMERGE)

Call 973-972-0607 for an appointment

The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.

http://clinicaltrials.gov/ct2/show/NCT01001754

The Liver Center at the New Jersey Medical School recently participated in a naive and relapse patient phase I clinical trial to investigate the use of type III lambda (λ) interferon to treat hepatitis C infection. The IFN-λ receptor, compared to theIFN-α receptor, is expressed only on epithelial-derived cells, including hepatocytes. The IFN-λ receptor is not expressed on CD34+ hematopoietic cells, circulating T lymphocytes or monocytes. PEGylated IFN-λ (PEG IFN-λ) is under development as a potential treatment for hepatitis C virus (HCV) infection and liver cancer. (results to be published in Hepatology). Phase I data in HCV relapse patients treated with PEG IFN-λ mono-therapy showed an average 2-4 log fold decrease in viral load within 28 days of beginning treatment.

We will be recruiting patients for phase IIb trial in the treatment of HCV patients naive to treatment starting March 2010. If you have a patient that that you would like to refer for this trial please contact Susan Rivera RN at our Clinical Research Center at 973-972-3197 or Ismael Castaneda MD at 973-972-6812.

Mean (SE) Change in HCV RNA from Baseline following Four-Weeks of PEG-IFN-lambda + RBV in IFN-alpha Relapse and Treatment-Naïve Patients



PEG-IFN-lambda Virological Response



Neutrophil and Platelet Counts following Four Weeks of PEG-IFN-lambda + RBV in IFN-alpha Relapse and Treatment-Naïve Patients