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news.Romark Laboratories has announced the completion of enrollment into its Phase II clinical trial to evaluate the safety and efficacy of nitazoxanide in combination with standard of care therapy in US patients with chronic hepatitis C genotype 1 who have previously failed to respond to the standard of care therapy.
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The study, called Stealth C-2, is the second in a series of clinical trials designed to evaluate the safety and efficacy of nitazoxanide tablets in combination with Pegasys (peginterferon alfa-2a) or peginterferon and Copegus (ribavirin) in patients with chronic hepatitis C. STEALTH C-2 is a randomized, double-blind, placebo-controlled trial conducted in the US in 60 patients with chronic hepatitis C genotype 1, who are non-responders to prior peginterferon and ribavirin therapy.
The study is designed to evaluate the effectiveness and safety of nitazoxanide administered 500mg twice daily for four weeks followed by nitazoxanide plus Pegasys plus Copegus combination therapy for 48 weeks, compared to placebo for four weeks followed by placebo plus Pegasys plus Copegus combination therapy for 48 weeks. Pegasys and Copegus are being provided under a collaborative agreement between Romark and Hoffmann-La Roche.
Marc Ayers, CEO of Romark, said: “We believe nitazoxanide represents a promising approach to the treatment of hepatitis C for the millions of people who are infected with this serious liver disease.”