The majority of research done within the section examines the efficacy and safety of various treatments for chronic hepatitis C, however, there are ongoing clinical trial assessing treatments of other Gastroenterology and Hepatology problems which the section may participate in. In addition, research is being initiated looking at risk factors for hepatitis C in respect to treatment response, as well as doing an analysis of quality of life and the cost involved in treatment.

Clinical Research Studies

1. A Multicenter Double- blinded study in non-cirrhotic patients with chronic Hepatitis C who are non-responders to prior Interferon Alfa or Interferon + Ribavirin therapy, comparing treatment with Thymosin Alpha 1+ Peginterferon Alfa-2a with Peginterferon Alfa-2a + placebo.

Sponsoring agency is SciClone Pharmaceuticals

2. A phase II multi-center, randomized, placebo controlled study of the safety and efficiency of InterferonGamma-1b (IFN-y1b) in patients with severe liver Fibrosis or compensated cirrhosis due to Hepatitis C.

Sponsoring agency is InterMune Inc.

3. PEG-tron (tm) maintenance therapy vs. untreated control group for prevention of progression of Fibrosis in adult subjects with Chronic Hepatitis C with Hepatic Fibrosis who failed therapy with PEG-intron plus Rebetol.

Sponsoring agency is Schering-Plough

4. A multicenter double-blinded study in patients with compensated Cirrhosis due to Chronic Hepatitis C, who are non-responders to prior Interferon Alfa+ Ribavirin therapy, comparing treatment with Thymosin Alpha 1 + Peginterferon Alfa 2a with Peginterferon Alfa-2a + Placebo.

Sponsoring agency is SciClone Pharmaceuticals

5. 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 Interferon plus Ribavirin.

Sponsoring agency is Schering- Plough

6. PEG- Intron plus REBETOL for the treatment of subjects with Chronic Hepatitis C who failed to respond to previous combination therapy (any Interferon treatment in combination with Ribavirin).

Sponsoring agency is Schering-Plough

7. Randomized, partially blinded, multicenter, phase III, three arm study evaluating the efficiency and safety of Pegyated-Interferon alfa-2a monotherapy vs combination therapy of Pegyated-Interferon alfa2-a with Ribavirin vs combination therapy of Interferon alfa-2a with Ribavirin for 48 weeks and 24 weeks of follow-up in patients with Chronic Hepatitis C co-infected with Human Immunodeficiency Virus.

Sponsoring agency is Hoffmann-La Roche Inc

8. An extension protocol to evaluate the long term effects of treatments with Peginterferon alfa-2a(PEG-IFN) or Interferon (IFN) based therapies for patients with Chronic Hepatitis C.

Sponsoring agency is Hoffmann- La Roche Inc.