Women able to become pregnant have regular pregnancy tests. All patients are followed for an additional 24 weeks after treatment discontinuation. Phase Phase II A phase two trial follows phase one. It consists of a larger, randomized sample of patients. The purpose of a phase two trial is to see if the drug is effective at doing what the manufacturer claims it should do.
Researchers also watch closely for unexpected adverse reactions.
Chronic liver disease consistent with chronic hepatitis C infection on a liver biopsy obtained within the 48 weeks prior to study entry, as judged by a local pathologist. Eligible patients must have a total Knodell Histologic Activity Index score of greater than 0. Within 35 days before study entry. Not breast-feeding Not pregnant Negative pregnancy test. The 2 substudies are not suitable for the inclusion of prisoners.