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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05297448
The ClinicalTrials.gov registry entry for NCT05297448 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 466 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 138-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target (238% 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.
NCT05297448 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
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