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NCT05297448 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis
A Phase 3 study of Hepatic Encephalopathy, sponsored by Bausch Health Americas.
- Active
- Registry status
- Phase 3
- Development phase
- 466
- Enrollment target
- 20
- Study locations
NCT05297448: Active Phase 3 study of Hepatic Encephalopathy, sponsored by Bausch Health Americas.
NCT05297448 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 466 participants, above the 138-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (238% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05297448, 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
- 466 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Rifaximin SSD
Study Locations (20)
California
- Bausch Site 550 - Bakersfield
- Bausch Site 415 - Coronado
- Bausch Site 585 - Covina
- Bausch Site 585 - Covina
- Bausch Site 592 - Fresno
- Bausch Site 582 - Lancaster
- Bausch Site 590 - Long Beach
- Bausch Site 414 - Los Angeles
- Bausch Site 405 - Orange
- Bausch Site 482 - Valencia
Florida
- Bausch Site 425 - Doral
- Bausch Site 449 - Hialeah
- Bausch Site 558 - Hialeah
- Bausch Site 418 - Hialeah
- Bausch Site 468 - Hollywood
Arizona
- Bausch Site 445 - Chandler
- Bausch Site 453 - Sun City
- Bausch Site 587 - Tucson
Alabama
- Bausch Site 591 - Homewood
Colorado
- Bausch Site 575 - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 466 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2026-01 |
| Phase | Phase 3 |
What the registry record for NCT05297448 still lists
NCT05297448 is an interventional study that assigns participants to a tested intervention. The registered 466 participants enrollment target is mid-sized for trials with a published cap, above the 138-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (238% higher).
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.
NCT05297448 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05297448 about?
NCT05297448 is a clinical study titled "Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis". 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 con...
What is the current status of trial NCT05297448?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 466 participants. The study started on 2022-08-03. Estimated completion is 2026-01.
What conditions does trial NCT05297448 study?
This clinical trial studies the following conditions: Hepatic Encephalopathy.
What interventions are being tested in trial NCT05297448?
The interventions under investigation include: Placebo (DRUG), Rifaximin SSD (DRUG).
Who is sponsoring clinical trial NCT05297448?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05297448 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Encephalopathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05297448's enrollment target sits among peer trials
466 2nd of 12 the highest of 12 other Hepatic Encephalopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Encephalopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
ACTIVE NOT RECRUITING · Phase 3
-
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
COMPLETED · Phase 3
-
Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement
RECRUITING · Phase 2
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Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
RECRUITING · NA
-
TReatment for ImmUne Mediated PathopHysiology
RECRUITING · Phase 2
-
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
RECRUITING · NA
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