At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C Non 2 -3 Genotype naïve Patients Treated With a 12 Weeks Bitherapy of Peginterferon Alpha 2a-ribavirin, and Followed by a Tritherapy of Peginterferon Alpha 2a-ribavirin-amantadine for 36 Weeks
In Brief
A Phase 2 clinical trial evaluating Ribavirine for Chronic Hepatitis C. Completed, enrolled 30 participants across 2 sites.
Detailed 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