Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199719
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2005-09-14
Brief Title:
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C CINAM
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CINAM
Brief 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
The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of ribavirin in hepatitis C patient
Detailed Description:
The study is conducted in naive patients infected with genotype non 2 non 3 administered peginterferon alpha 2-a 40KD weekly and ribavirin with dose adjusted on BW 75 kg 1000 mgday 75 kg 1200 mgday for the first three months with adjunction of amantadine 200 mg daily for the following 9 months
Plasma concentration profiles of ribavirin were studied after the first dose D0 and at W12 At each period blood samples were collected pre-dose and 30 minutes 1 15 2 3 4 6 8 and 10 hours post-dosing Ribavirin concentrations were measured using liquid chromatography-tandem mass spectrometry and ribavirin area under the concentration-timcurves AUC0-10h were derived from plasma concentrations profiles using the linear trapezoidal rule
Virological follow-up was performed at W2 W4 W6 W8 W12 W24 and W72 Early virological response was defined by undetectable viral load at W12
Plasma concentration profiles of ribavirin were studied after the first dose D0 and at W12 At each period blood samples were collected pre-dose and 30 minutes 1 15 2 3 4 6 8 and 10 hours post-dosing Ribavirin concentrations were measured using liquid chromatography-tandem mass spectrometry and ribavirin area under the concentration-timcurves AUC0-10h were derived from plasma concentrations profiles using the linear trapezoidal rule
Virological follow-up was performed at W2 W4 W6 W8 W12 W24 and W72 Early virological response was defined by undetectable viral load at W12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None