Critical Hepatitis C Phase III Trial
Schering-Plough completes enrollment in registration studies of hepatitis drug
By Datamonitor staff writer
Schering-Plough has completed patient enrollment in the boceprevir hepatitis C virus Sprint-2 study, a pivotal Phase III study in treatment-naive patients.
Together with the hepatitis C virus (HCV) Respond-2 study, a pivotal Phase III study in patients who failed prior treatment that completed enrollment in November 2008, the company has fully enrolled its registration studies for boceprevir, its lead investigational oral hepatitis C protease inhibitor. A total of more than 1,500 patients were enrolled in these studies at US and international sites.
The HCV Sprint-2 study evaluates the efficacy of 28- and 48-week regimens of boceprevir (800mg TID) in combination with Pegintron (1.5mcg/kg/week) and Rebetol (600-1,400mg/day) compared to a control of Pegintron and Rebetol alone for 48 weeks in treatment-naive adult patients with chronic HCV genotype 1. The study enrolled a total of 1,099 patients, including 158 African-American or black patients.
The HCV Respond-2 study evaluates 36- and 48-week regimens of boceprevir in combination with Pegintron and Rebetol at the same doses as described above compared to a control of Pegintron and Rebetol alone for 48 weeks in adult patients with chronic HCV genotype 1 who failed prior treatment (relapsers and nonresponders) with peginterferon and ribavirin combination therapy. The study enrolled a total of 404 patients.
In both studies, RVR criteria at four weeks of boceprevir treatment (treatment week eight) is used to determine which boceprevir patients can stop all treatment at 28 weeks (HCV Sprint-2) or 36 weeks (HCV Respond-2). The company expects to complete the studies in mid-2010.
Thomas Koestler, executive vice president and president of Schering-Plough Research Institute, said: “We believe boceprevir has the potential to be a first-in-class and best-in-class protease inhibitor for treating chronic hepatitis C. We are very encouraged by the boceprevir study results reported to date and look forward to the completion of these registration studies.”
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