The Effects of Oral Hypoglycemic Agents on Chronic Hepatitis C Patients Receiving Peg-Intron Plus Ribavirin
Status:
Unknown status
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Pegylated interferon in combination with ribavirin is the current standard treatment of
chronic hepatitis C virus infection, but is expensive and has several adverse effects. To
modify this standard treatment by optimizing its therapeutic effect and decreasing its
adverse events are important. Recent studies have identified a close link between metabolic
profiles, insulin resistance and Hepatitis C Virus (HCV) infection. Several pilot studies in
western world have have found beneficial effects of oral hypoglycemic agents on chronic
Hepatitis C (CHC) genotype 1 infected patients. Whether this concept still holds true in
Taiwanese people remains unknown.
The objective of this clinical trial is to evaluate the effect of oral hypoglycemic agents
(daily for 4 weeks of run-in period and 8 weeks of combination treatment) on CHC genotype 1
infected Taiwanese patients receiving 48 weeks of Peg-IFN plus ribavirin (RBA), and the
enrolled subjects will be randomized into 4 treatment groups (including Acarbose, Metformin,
Pioglitazone and standard care control groups). During the trial and 24 weeks after the end
of treatment, serial serum HCV RNA, alanine aminotransferase (ALT) levels, and other clinical
data will be evaluated to determine the therapeutic response and adverse events of the CHC
patients.