Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310336
Status:
COMPLETED
Last Update Posted:
2010-10-28
First Post:
2006-03-31
Brief Title:
Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Chronic Hepatitis C Treatment of PegInterferon Alpha - Ribavirin Non-Responders With Pegylated Interferon alpha2b Ribavirin AdoMet and Betaine
Status:
COMPLETED
Status Verified Date:
2010-10
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:
50-60 of patients with chronic hepatitis C are not cured by treatment with pegylated IFNα plus ribavirin
Retreatment of non-responders of previous pegylated IFNα plus ribavirin therapies with pegylated IFNα plus ribavirin results in a sustained response in less than 10 of the patients
Extensive analysis of IFNα signaling in cells expressing HCV proteins in transgenic mice expressing HCV proteins and in liver biopsies from patients with chronic hepatitis C point to STAT1 methylation as an important posttranslational modification targeted by HCV to inhibit IFNα signaling
STAT1 methylation can be increased and IFNα can be improved by adding AdoMet and betaine
The study is designed to test the hypothesis that a combination treatment with pegylated IFNα2b ribavirin AdoMet and betaine is superior to the current standard combination therapy with pegylated IFNα plus ribavirin
Retreatment of non-responders of previous pegylated IFNα plus ribavirin therapies with pegylated IFNα plus ribavirin results in a sustained response in less than 10 of the patients
Extensive analysis of IFNα signaling in cells expressing HCV proteins in transgenic mice expressing HCV proteins and in liver biopsies from patients with chronic hepatitis C point to STAT1 methylation as an important posttranslational modification targeted by HCV to inhibit IFNα signaling
STAT1 methylation can be increased and IFNα can be improved by adding AdoMet and betaine
The study is designed to test the hypothesis that a combination treatment with pegylated IFNα2b ribavirin AdoMet and betaine is superior to the current standard combination therapy with pegylated IFNα plus ribavirin
Detailed Description:
None
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