Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine
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.
|Hepatitis C||Drug: S-adenosyl-L-methionine Drug: betaine Drug: pegylated interferon alpha2b Drug: ribavirin||Phase 2 Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Chronic Hepatitis C: Treatment of (Peg)Interferon Alpha - Ribavirin Non-Responders With Pegylated Interferon alpha2b, Ribavirin, AdoMet and Betaine|
- Sustained response rate
- Early virologic response after 12 weeks of therapy with PegIntron, Rebetol, AdoMet and betaine.
|Study Start Date:||August 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310336
|University Hospital Basel|
|Basel, BS, Switzerland, 4031|
|Principal Investigator:||Markus H Heim, MD||University Hospital, Basel, Switzerland|