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Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine

NCT00310336 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-10-28

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DRUG

S-adenosyl-L-methionine

DRUG

betaine

DRUG

pegylated interferon alpha2b

DRUG

ribavirin

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Markus H Heim, MD · University Hospital, Basel, Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00310336 on ClinicalTrials.gov