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NCT05071716 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
A Phase 3 study of Hepatic Encephalopathy, sponsored by Bausch Health Americas.
- Active
- Registry status
- Phase 3
- Development phase
- 524
- Enrollment target
- 20
- Study locations
NCT05071716 is a Phase 3 study of Hepatic Encephalopathy that is active but no longer recruiting, run by Bausch Health Americas. The registered enrollment target is 524 participants, above the 133-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (294% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT05071716, a Phase 3 study of Hepatic Encephalopathy, is active but no longer recruiting, sponsored by Bausch Health Americas.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 524 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study RNLC3131 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 Studied
Interventions
- DRUG Placebo
- DRUG Rifaximin SSD
Study Locations (20)
California
- Bausch Site 164 - Bakersfield
- Bausch Site 196 - Chula Vista
- Bausch Site 226 - Chula Vista
- Bausch Site 174 - Escondido
- Bausch Site 163 - Fresno
- Bausch Site 242 - Garden Grove
- Bausch Site 115 - La Jolla
- Bausch Site 141 - Lancaster
- Bausch Site 140 - Los Angeles
- Bausch Site 189 - Los Angeles
- Bausch Site 227 - Orange
- Bausch Site 199 - Pasadena
Arizona
- Bausch Site 129 - Chandler
- Bausch Site 103 - Peoria
- Bausch Site 180 - Phoenix
- Bausch Site 153 - Phoenix
- Bausch Site 248 - Tempe
- Bausch Site 222 - Tucson
Alabama
- Bausch Site 182 - Dothan
Arkansas
- Bausch Site 150 - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 524 participants |
| Start Date | 2022-04-07 |
| Est. Completion | 2025-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05071716
The ClinicalTrials.gov registry entry for NCT05071716 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 524 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 133-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (294% higher). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatic Encephalopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05071716 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05071716 about?
NCT05071716 is a clinical study titled "Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis". Study RNLC3131 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 con...
What is the current status of trial NCT05071716?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 524 participants. The study started on 2022-04-07. Estimated completion is 2025-09.
What conditions does trial NCT05071716 study?
This clinical trial studies the following conditions: Hepatic Encephalopathy.
What interventions are being tested in trial NCT05071716?
The interventions under investigation include: Placebo (DRUG), Rifaximin SSD (DRUG).
Who is sponsoring clinical trial NCT05071716?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05071716 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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