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Romark Announces Final Data From Clinical Trial of Nitazoxanide in Treatment-Naive Patients With Genotype 1 Chronic Hepatitis C
Date:5/4/2010

TAMPA, Fla., May 4 /PRNewswire/ -- Romark Laboratories announced results from its STEALTH C-3 clinical trial, a phase 2 clinical study of nitazoxanide in treatment-naive patients with genotype 1 chronic hepatitis C.  Study results were presented this afternoon as an oral communication at a late breaking forum of the American Gastroenterological Association Institute (AGA Institute) during Digestive Disease Week 2010 in New Orleans, Louisiana.

(Logo: http://www.newscom.com/cgi-bin/prnh/20100201/FL47022LOGO )

The study was a randomized, double-blind, placebo controlled trial conducted at thirteen centers in the United States in patients with genotype 1 chronic hepatitis C, 35% of whom had advanced stage 3 or 4 fibrosis.  One-hundred and twelve patients were randomized to receive either nitazoxanide (500 mg twice daily) plus peginterferon alfa-2a (Pegasys®, F. Hoffman LaRoche) and ribavirin (Copegus®, F. Hoffman LaRoche) (n=75) or placebo plus Pegasys® and Copegus® (n=37).  The primary endpoint of the study was sustained virologic response (SVR, undetectable HCV RNA 24 weeks after the end of treatment).  SVR occurred in 44% of patients treated with nitazoxanide plus standard therapy for 48 weeks versus 32% of patients treated with placebo plus standard therapy. SVR rates were consistently higher in subsets of patients with high baseline viral load (41% vs. 29%) and in African Americans (38% vs. 20%).  Safety analyse
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SOURCE Romark Laboratories, L.C.
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