Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers
Status:
Terminated
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
This is a non-randomized, open-label study examining the safety and efficacy of betaine in
addition to standard anti-viral therapy in genotype 1 hepatitis C non-responders or relapsers
to previous pegylated interferon plus ribavirin. Betaine (20 gm/day) in 2 divided doses will
be added to Peginterferon alpha 2a (180 mcg) plus weight-based Ribavirin (1000 or 1200
mg/day, for body weight < or > 75 kg, respectively, for 48 weeks. Patients must be diagnosed
with chronic hepatitis C, genotype I, and have undergone therapy for hepatitis C with
pegylated interferon plus ribavirin. Subjects will be followed for safety, tolerability,
hepatitis C viral response and the effect on interferon gene signaling in peripheral blood
mononuclear cells during therapy.