Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine
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|ClinicalTrials.gov Identifier: NCT00310336|
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : October 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: S-adenosyl-L-methionine Drug: betaine Drug: pegylated interferon alpha2b Drug: ribavirin||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chronic Hepatitis C: Treatment of (Peg)Interferon Alpha - Ribavirin Non-Responders With Pegylated Interferon alpha2b, Ribavirin, AdoMet and Betaine|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||September 2009|
- Sustained response rate
- Early virologic response after 12 weeks of therapy with PegIntron, Rebetol, AdoMet and betaine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310336
|University Hospital Basel|
|Basel, BS, Switzerland, 4031|
|Principal Investigator:||Markus H Heim, MD||University Hospital, Basel, Switzerland|