Schering-Plough is initiating two large Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, in patients chronically infected with hepatitis C virus genotype 1.
One study will be in untreated patients. The other will be in patients who failed prior treatment. The two randomized, double-blind, placebo-controlled studies will evaluate the efficacy of boceprevir in combination with Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) compared with treatment with Pegintron and Rebetol alone.
The company said the two studies will run concurrently and are projected to enroll more than 1,400 patients at U.S. and international sites.