Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis

NCT05297448 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 466 participants
Start Date 2022-08-03
Est. Completion 2026-01
Phase Phase 3

Sponsor

Bausch Health Americas

55 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 466 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05297448 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05297448?

The interventions under investigation include: Placebo (DRUG), Rifaximin SSD (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05297448?

This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial