Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Peg interferon and ribavirin currently represent the standard approved association for treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is expected to gain about 10 % of sustained virological response (SVR) . Unfortunately, about 50 % of the patients remain relapsers or virological non responders. The main predictive factors of SVR are HCV genotype and body weight (BW). The impact of the drug pharmacological properties, particularly those of ribavirin requires complementary studies. This drug has a large distribution volume and its concentrations display large inter-individual variability. Two studies performed in HCV patients found no correlation between ribavirin dose adjusted on BW and a single ribavirin time point serum concentration at steady state.

The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of ribavirin in hepatitis C patient

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Collaborator: Hoffmann-La Roche
• Treatments: Amantadine; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Male and female patients >18 years of age and <65 years of age

• Génotype non2 non3

• Chronic liver disease consistent with chronic hepatitis C infection on a biopsy (obtained within the past 24 months) as judged by a local pathologist (Metavir >A1and >F1)

• Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug

Exclusion Criteria:

• Women with ongoing pregnancy or breast feeding

• IFN or ribavirin therapy at any previous time

• Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab

• History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)

• Serum creatinine level >1.5 times the upper limit of normal at screening

• History of severe psychiatric disease, especially depression