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news.Romark Laboratories has started enrolling patients in a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate nitazoxanide for the treatment of chronic hepatitis C.
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The study, Stealth C-3, is designed to evaluate the safety and efficacy of nitazoxanide in combination with (Pegasys, Roche) and ribavirin (Copegus, Roche) in treatment naive patients with chronic hepatitis C infected with genotype 1.
The primary objective of Stealth C-3 is to evaluate sustained virologic response (SVR) with a treatment regimen of four weeks of nitazoxanide lead-in therapy followed by 48 weeks of standard of care plus nitazoxanide versus four weeks of placebo lead-in followed by 48 weeks of standard of care and placebo. The trial will enroll 60 patients at 15 centers in the US. Preliminary data from the study is expected in the second half of 2008.
Emmet Keeffe, chief medical officer of Romark, said: “This study and our ongoing Stealth C-2 trial are designed to evaluate the effect of treatment with nitazoxanide plus standard of care in patients with genotype 1. Future clinical trials will explore new combinations and treatment durations, including current and emerging hepatitis C virus (HCV) therapies.”