NCT01904409

Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	Rifaximin SSD 40 mg IR tablet
DRUG	Rifaximin SSD 80 mg IR tablet
DRUG	Rifaximin SSD 40 mg SER tablet
DRUG	Rifaximin SSD 80 mg SER tablet
DRUG	Rifaximin SSD 80mgIR/80mgSER tablet

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2013-07-22
• Last updated: 2019-10-23

Locations

120 sites across 2 countries: United States, Russia