Hepatitis C

Interferon Resistance in Genotype 1 Infected Patients
Available for genotype 1-infected patients who have never been treated for Hepatitis C. The purpose behind the study is to assess the viral kinetics in patients receiving treatment with pegylated interferon and ribavirin.

Phase 2a, Randomized, Dose-Ranging, Open-label Study of the Safety and Tolerability of Consensus Interferon-Alpha (CIFN) plus Interferon Gamma-1b (IFN-? 1b) with or without Ribavirin (RBV) in the Treatment of Patients with Chronic Hepatits C who are Non-responders to PEG-IFN-a (2a or 2b) plus RBV.
Available for patients (all genotypes) who have not responded to pegylated interferon (Peg-Intron or Pegasys) and ribavirin. Patients will be randomized into cohorts with differing doses of daily CIFN, thrice weekly IFN-Gamma 1b, and ribavirin.

A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Afacon-1 (Infergen, CIFN) plus Rivavirin Administered for 48 Weeks Versus No-treatment in Hepatitis C Infected Patiuents Who are Nonresponders to Previous Pegylated Interferon Alfa Plus Ribavirin Therapy
Available for patients (all genotypes) who have not responded to pegylated interferon (Peg-Intron or Pegasys) and ribavirin. Patients will be randomized into a control group, receiving no treatment, or into a treatment group receiving daily CIFN and ribavirin for 48 weeks.

Evaluation of Viral Kinetics and Pharmacokinetics of Pegasys and Copegus and PEG-Intron and Rebetol in Patients Who Have Never Been Treated for Hepatitis C
Available for genotype 1-infected patients who have never been treated for Hepatitis C. Patients will be randomized into two groups using either Pegasys and Copegus or PEG-Intron and Rebetol for 12 weeks. Patients who wish to continue with treatment after 12 weeks will be given Pegasys and Copegus. The first 12 weeks of this study is fully funded by Roche.

Hepatitis C Virus Kinetics after Liver Transplantation: Impact of Living Donor Liver Transplantation and Pre-Transplant Antiviral Therapy
Available for patients waiting for liver transplantation with Hepatitis C. Patients will be randomized into 3 groups: cadaveric liver transplantation, living donor liver transplantation, or living donor transplantation who will receive treatment for HCV with pegylated interferon and ribavirin for 12 weeks before the transplant operation.

Hepatitis C in Hispanics
Available for the 1,225 patients (Hispanic, Caucasian, African American) identified during the retrospective chart review of patients with HCV infection seen in the Digestive Disease and Liver Clinic at UIC. Involves calling the patient to ask questions about height, history of diabetes, medicine – if any – for diabetes, family history of diabetes, history of high cholesterol, medicines – if any – for high cholesterol, history of high blood pressure, and alcohol use. The study will further evaluate whether nonalcoholic fatty liver disease might be a co-factor leading to more rapid progression to cirrhosis in some Hispanics with hepatitis C.

Hepatocellular Carcinoma

Study of DENSPM in Patients with Hepatocellular Carcinoma
Available for patients with unresectable (non-surgically removable) liver tumors. Patients will receive infusions of DENSPM to reduce the size or stop the growth of liver tumors.

NASH

An Evaluation of Hepatic Fat Quantitation by MRI
Available for patients needing a standard liver biopsy for clinical evaluation of suspected NASH (nonalcoholic steatohepatitis). One-third of the liver biopsy will be frozen for research fat extraction and the rest will be analyzed in the standard clinical way. Patients will have an MRI scan of their liver. The scan will be compared to the biopsy to determine if an MRI is a viable alternative to a liver biopsy for analyzing the amount of fat in the liver.

A Pilot Study to Evaluate the Effect of Combination Therapy of Omega-3 Fatty Acids and Vitamin E on Hepatic Steatosis and Factors Associated with Steatohepatitis
Available for patients (liver) biopsy-proven NASH (nonalcoholic steatohepatitis). Patients will receive an MRI scan before treatment starts to measure the amount of fat in and around the liver. Patients will meet with a dietitian regarding gradual weight loss and will be randomized into two groups – one receiving omega-3 fatty acids (fish oil) and vitamin E – and one receiving no supplementation. Another MRI scan will be performed on all patients at the end of the study. There is no standard-of-care treatment for fatty liver and the effect of supplementation with omega-3 fatty acids combined with vitamin E needs to be studied.

A Pilot Study of the Interaction Among Sleep Apnea, Nonalcoholic Fatty Liver Disease and Oxidative Stress
Available for patients with (liver) biopsy-proven diagnosis of NASH (nonalcoholic steatohepatitis) and a BMI (body mass index) of >30. Patients will be admitted to the General Clinical Research Center (GCRC) for an overnight sleep study with blood tests to evaluate whether they have sleep apnea. If a patient does have sleep apnea, they will be asked to return for another overnight sleep study using a CPAP machine to control the apnea and for blood tests. This study will evaluate whether NASH, combined with sleep apnea increases oxidative stress and consequently increases liver damage.

Paracentesis for Ascites

A Comparative Safety and Efficacy Study of Octalbin 25% and BUMINATE 25% in the Prevention of Central Volume Depletion in Subjects with Cirrhotic Ascites
Available for patients requiring multiple paracenteses or patients who have undergone one or no paracentesis for ascites. This study will investigate the safety and efficacy of Octalbin, a human blood product versus BUMINATE following paracentesis.