Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
Summary
This is an open-label, randomized, comparative, multicenter, 48-week study designed to
evaluate the efficacy and safety of combination treatment with pegylated interferon and
ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C
virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24
weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects
will be randomly assigned to one of two study groups. One group will be followed for an
additional 48 weeks without study medication, while the other will be continuously treated
for an additional 24 weeks and then followed for another 24 weeks without study medication.
Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the
follow-up period, will be measured along with other outcomes.