CompletedPhase 2

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

France30 participantsStarted 2003-06

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

-Study of the complete pharmacokinetics of ribavirin at day 1, and day 84 (week 12).

-Study of the complete pharmacokinetics of amantadin and ribavirin at week 12 + one day and at week 24

Trial details

NCT IDNCT00199719

SponsorUniversity Hospital, Limoges

Sponsor typeOTHER

Study typeINTERVENTIONAL