Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122629
Status:
TERMINATED
Last Update Posted:
2005-07-29
First Post:
2005-07-20
Brief Title:
Triple Therapy With Peg-Interferon Alfa-2bRibavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2bRibavirin for Previous Hepatitis C Virus HCV Non Responders
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Triple Therapy With Peg-Interferon Alfa-2bRibavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2bRibavirin for Previous HCV Non Responders ANRSHC03 BITRI
Status:
TERMINATED
Status Verified Date:
2005-07
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:
None
Brief Summary:
Triple antiviral therapy with peg-interferon-alfaribavirinamantadine was suggested to increase sustained virological response SVR rates in HCV non-responders to a standard interferonribavirin combination
Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferonribavirin combination therapy Non-response was defined as persistent HCV RNA in the serum during the last month of treatment
This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks
Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferonribavirin combination therapy Non-response was defined as persistent HCV RNA in the serum during the last month of treatment
This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks
Detailed Description:
Triple antiviral therapy with peg-interferon-alfaribavirin amantadine was suggested to increase sustained virological response SVR rates in HCV non-responders to a standard interferonribavirin combination
The aim of this study is to determine if the addition of amantadine to PEG-IFNribavirin enhances SVR
This study is a double blind comparative prospective multicenter randomized study Patients are recruited from 23 hepatology centers in France The protocol was approved by the French ethical committee and all patients provided written informed consent Eligible subjects are randomly assigned to the two treatment groups in equal proportions The randomization process is generated by the Department of Biostatistics Hospices Civils de Lyon Lyon France
Main inclusion criteria are elevated ALT detectable HCV RNA Metavir score over or equal to A1F1 and below or equal to F3 Patients received PEG-IFN 15µgkgweek ribavirin 800-1200mgday and amantadine 200mgday or placebo during 48 weeks
The primary endpoint is a sustained virological response defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation week 72 Secondary endpoints are the biochemical response at week 72 defined as ALT normalization histological benefit tolerance and virological and biochemical responses during therapy at weeks 12 24 and 48
The aim of this study is to determine if the addition of amantadine to PEG-IFNribavirin enhances SVR
This study is a double blind comparative prospective multicenter randomized study Patients are recruited from 23 hepatology centers in France The protocol was approved by the French ethical committee and all patients provided written informed consent Eligible subjects are randomly assigned to the two treatment groups in equal proportions The randomization process is generated by the Department of Biostatistics Hospices Civils de Lyon Lyon France
Main inclusion criteria are elevated ALT detectable HCV RNA Metavir score over or equal to A1F1 and below or equal to F3 Patients received PEG-IFN 15µgkgweek ribavirin 800-1200mgday and amantadine 200mgday or placebo during 48 weeks
The primary endpoint is a sustained virological response defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation week 72 Secondary endpoints are the biochemical response at week 72 defined as ALT normalization histological benefit tolerance and virological and biochemical responses during therapy at weeks 12 24 and 48
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