Liver Cirrhosis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications in Subjects With Early Decompensated Liver Cirrhosis
The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo
in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all
causes) or hospitalization, in subjects with early decompensated liver cirrhosis.
Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for
the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver
cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin.
Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for
24 weeks.
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