Trials / Active Not Recruiting
Active Not RecruitingNCT05297448
Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 466 (estimated)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rifaximin SSD | Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily |
| DRUG | Placebo | Placebo Twice Daily |
Timeline
- Start date
- 2022-08-03
- Primary completion
- 2026-01-01
- Completion
- 2026-01-01
- First posted
- 2022-03-28
- Last updated
- 2025-09-10
Locations
188 sites across 17 countries: United States, Australia, Belgium, Bulgaria, Canada, France, Germany, Hungary, India, Italy, Mongolia, New Zealand, Poland, Puerto Rico, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05297448. Inclusion in this directory is not an endorsement.