Alinia Tablets and Hepatitis C
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RxTrials Institute Drug Pipeline Alert
Aug. 20, 2007 | Vol. 5 No. 163
http://fdanews.com
Romark Begins Trial of Alinia for Chronic Hepatitis C
Romark Laboratories has initiated a Phase II clinical trial of Alinia for treating chronic hepatitis C in the U.S.
According to Romark, the clinical trial is designed to evaluate the effectiveness and safety of Alinia (nitazoxanide) tablets administered in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in 60 patients with chronic hepatitis C genotype 1 who have failed to respond to standard therapy (peginterferon and ribavirin).
The trial is part of the company’s Studies to Evaluate Alinia for Treatment of Hepatitis C (STEALTH C) clinical development program, a series of clinical trials designed to evaluate the safety and efficacy of Alinia tablets in combination with peginterferon or peginterferon and ribavirin in patients with chronic hepatitis C.
The trial is designed to evaluate the effectiveness and safety of Alinia administered 500 mg twice daily for four weeks followed by Alinia-Pegasys-Copegus combination therapy for 48 weeks compared to placebo for four weeks followed by placebo-Pegasys-Copegus combination therapy for 48 weeks, which is the standard of care.
