The ALF Illinois Chapter tries to bring you a complete list of ongoing clinical trials and research. However, we suggest you ask your nurse or physician if there are any other studies affiliated with their hospital.  Updated 09.12.06.

Northwestern University

Hepatitis C

PEG-Intron Plus Rebetol for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (any alpha Interferon Treatment in Combination with Ribavirin)
Patients who were non-responders or relapsers to any type of interferon (including pegylated interferon) and ribavirin with METAVIR F2, F3, or F4 to be treated with pegylated interferon and ribavirin. This study is one part of a two part program which first offers PEG-Intron plus Rebetol to patients with METAVIR F2, F3 or F4 who have failed alpha interferon plus ribavirin therapy. The second part of the program identifies non-responders and offers them entrance into a maintenance therapy study.
Contact: Noreen Osman @ 312-503-0122

PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects with Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy with Any Alpha Interferon Plus Ribavirin
To assess the safety and efficacy of PEG-Intron 0.5 ug/kg weekly as maintenance therapy vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with any alpha interferon (including pegylated interferon) plus ribavirin.
Contact: Noreen Osman @ 312-503-0122

PEG-Intron Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects with Chronic Hepatitis C with Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), who Failed Therapy with PEG-Intron plus Rebetol
To assess the safety and efficacy of PEG-Intron 0.5 ug/kg weekly as maintenance therapy vs. an untreated control group in adult subjects with chronic Hepatitis C with hepatic fibrosis (METAVIR Fibrosis score F2 or F3) to determine if longer maintenance therapy with PEG-Intron will retard or reverse the progression of fibrosis, thus preventing the development of cirrhosis.
Contact: Noreen Osman @ 312-503-0122

Peg Intron plus Rebetol vs. Pegasys plus Copegus for HCV patients with genotype 1 who have never been treated with any interferon or ribavirin product.
Two different doses of Peg-Intron plus Rebetol will be compared to standard doses of Pegasys plus Copegus.
Contact: Mary Kozlowski, RN @ 312-503-0125

CPG10101 Combination therapy for the treatment of hepatitis C: a phase 1B open-label, randomized trial of CPG10101 alone, with interferon, ribavirin, or interferon and ribavirin in the treatment of relapsed HCV subjects
The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called CPG10101 (Actilon- a toll-like receptor 9 antiviral agonist), when it is combined with pegylated interferon and ribavirin, for patients who have relapsed during previous treatment attempts.
Contact: Noreen Osman @ 312-503-0122

PEG-Intron/Rebetol vs PEG-Intron/SCH 503034 With and Without Ribavirin in Chronic Hepatitis C HCV 1 Peginterferon alfa/Ribavirin Nonresponders: A SCH 503034 Dose Finding Phase 2 Study (P03659)
The purpose of this study is to evaluate the safety and effectiveness of an investigational protease inhibitor when it is combined with pegylated interferon and ribavirin, for refractory patients.
Contact: Kim Sipich @ 312-503-0121

Rush University

Contact: Monique L. Williams, RN, BSN, Senior Research Coordinator, Section Of Hepatology, (312) 563-3919 office

Hepatitis B

Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the treatment of Chronic Hepatitis B subjects with Decompensated Liver Disease and in the Prevention of Hepatitis B Recurrence Post-Transplantation.

Inclusion
-Age 18-69
-Positive HBsAg for at least 6 mon.
-Plasma HBV Dna = 104 copies/ml
Decompensated Liver Disease:
-CPT score of 7-12
-Serum ALT < 10xULN
-Hgb = 7.5g/dl
-Total WBC = 1,500/mm3
-Platelet count = 30,000mm3
-AFP= 20mg/ml and u/s or other
-HCC, or AFP 21-50 and CT/MRI of no evidence of HCC w/n 6 months of screening.
-Negative for HIV, HCV and HDV Serologies.

Exclusion
-Prior use of tenofovir DF or entecavir
-Hx of variceal bleed, Grade 3 or 4 Encephalopathy
-Grade 2 hepatic encephalopathy at screening
-History of solid organ or bone marrow transplant
-Current use of hepatotoxic or nephrotoxic drugs
-Current therapy with immunomodulators
-Dx or proximal tubulopathy
-Use of any investigational agent w/n 30 days of screening
-Known sensitivity to tenofovir DF,emtricabine,imaging with no evidence of entecavir or formulation excipients of any of the study drug products.

Fully funded Latino study for genotypes 1 Naive patients. Accepting hispanic and caucasian patients. Must already have their genotypes confirmed.

Hepatitis C (Naive)
Pegays plus Copegus in a Double-Blinded Study. To compare the efficacy and safety of 360 ug  induction dosing of Pegasys for 12 weeks followed by a 180 ug maintenance dose of Pegasys for 36 weeks. Patients with Chronic Hepatitis C Genotype 1 Virus Infecton of high viral titer and baseline body weight greater than or equal to 85kg(187lbs). Exclusion: Previous HCV treatment, any other genotypes such as 2 or 3. No major organ transplantation and no co-infection. Contact: Monique L. Williams @ 312-563-3919 for detailed enrollment requirements.

University of Chicago

The University of Chicago's Liver Study Unit was established in 1971 to improve the treatment of patients with liver diseases and to encourage teaching and research about liver disorders. We are conducting many clinical trials including trials for patients with Hepatitis C, Hepatocellular Carcinoma (HCC) and Esophageal Varies. Listed below are the trials in which we are actively enrolling patients.

Hepatitis C (Treatment Naïve)
A Phase 2 Study of VX-950 in Combination with Pegylated Interferon With Ribavirin for Patients with Hepatitis C and liver biopsy within past 2 years. Inclusion criteria: Age 18-65 years, HCV, Genotype 1. Exclusion criteria: Previous HCV treatment, Cirrhosis, Decompensated liver disease, Alcohol or drug abuse within last 12 months.

Hepatitis C (Treatment Non-Responders, Naïve and Relapsers)
A Phase 1, Double-blind, Placebo Controlled, Dose-Escalation, Multi-Center Therapeutic Trial of the Safety, Immunogenicity and Efficacy of GI-5005; an Inactivated Recombinant Saccharomyces cerevisiae Expressing a Hepatitis C Virus NS3- Core Fusion Protein, in Patients with Chronic Hepatitis C Infection. Inclusion Criteria: HCV RNA level>1000 IU/mL, age 18 or older, liver biopsy w/in past 2 years, negative scratch test to S. cerevisiae. Exclusion Criteria: Decompensated liver disease, including portal hypertension, varices, ascites, cirrhosis, encephalopathy, HCC, HCV treatment w/in 3 months prior to screening, diabetes.

Hepatocellular Carcinoma (HCC)
A national registry of patients with hepatocellular carcinoma, which will evaluate the etiologic factors associated with HCC and to survey and stage the potential treatability of patients with HCC.

If you have any patients who may be interested in participating or you have any questions regarding the study, please do not hesitate to contact Dr. Helen Te, Dr. Smruti Mohanty, or Dr. Donald Jensen at (773) 702-2395 or Katie Wherity, R.N, BSN at (773) 702-4477.

University of Illinois at Chicago
Section of Hepatology

Investigators: Dr. Scott Cotler and Dr. Thomas Layden
Contact Person(s): Rebecca Duke, NP; Scott Cotler, MD
Telephone Number(s): 312-996-8907; 312-996-6929

Hepatitis C

A Phase IIb Clinical Trial to Evaluate the Combination of Pegylated Interferon Alfa plus Valopicitabine (NM283) in Treatment-Naïve Patients with Chronic Hepatitis C
Available for treatment-naïve patients with Hepatitis C. The purpose of this study is to evaluate the safety and viral activity of the protease inhibitor NM283 with peg-interferon alfa-2a in genotype 1a or 1b-infected patients who have a baseline viral load of at least 500,000. No liver biopsy will be required. The patients will be randomized to one of 4 treatment arms which all include NM283 and IFN. Patients will receive at least 24 weeks of treatment. If the patient demonstrates < 250,000 RNA at week 24 they will continue on study drug for up to week 48.

Interferon Resistance in Genotype 1 Infected Patients
Available for genotype 1-infected patients who have never been treated for Hepatitis C. The purpose of this study is to assess viral kinetics in patients receiving the standard treatment with peg-interferon alfa-2a and ribavirin. The study is available for African-American, Hispanic and Caucasian patients only. The study involves frequent blood draws and one overnight stay in the GCRC in the hospital.

Phase 2, 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-(2a or 2b) plus RBV. (CLOSED FOR ENROLLMENT AND WILL REOPEN SOON.)
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 daily ribavirin. If there is a > 2log drop in viral load at week 24, the patient will be continued on the treatment regimen until week 48

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 the primary liver disease of Hepatitis C. Patients will be placed in 3 groups: cadaveric liver transplantation, living donor liver transplantation, or living donor transplantation who will receive "standard" treatment for HCV with pegylated interferon and ribavirin for 12 weeks before the transplant operation. The study involves frequent blood draws one day before the operation, during the operation and up to 8 weeks post-op.

Hepatocellular Carcinoma

Study of DENSPM in Patients with Hepatocellular Carcinoma
Study of a new chemotherapeutic agent, DENSPM in patients with hepatocellular carcinoma. Available for patients with unresectable (cannot be surgically removed) liver tumors and who are not eligible for chemoembolization. Patients will receive infusions of DENSPM to reduce the size or stop the growth of liver tumors.

NASH

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 with 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 omega-3 fatty acid supplementation. Another MRI scan will be performed on all patients at the end of the study. Patients will receive treatment for 24 weeks. 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 and to track changes in liver enzymes overnight. 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 to evaluate if liver enzymes improve with treatment for the sleep apnea. This study will evaluate whether NASH, combined with sleep apnea increases oxidative stress and consequently increases liver damage.

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American Liver Foundation - Illinois Chapter
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