Evaluation of Rifaximin SSD for Delaying Encephalopathy D... | NCT05297448

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

NCT05297448

Sponsor

Bausch Health Americas, Inc.

Status

Active, not recruiting

Last Update Posted

Sep 10, 2025Actual

Enrollment

466Estimated

Phase

Phase 3

Conditions

Hepatic Encephalopathy

Interventions

Rifaximin SSD
Placebo

Countries

United States
Australia
Belgium
Bulgaria
Canada
France
Germany
Hungary
India
Italy
Mongolia
New Zealand
Poland
Puerto Rico
South Korea
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2022Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Mar 17, 2022

First Submission Date that Met QC Criteria

Mar 17, 2022

First Posted Date

Mar 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2025

Last Update Posted Date

Sep 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

466Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rifaximin SSD-40mg IR	Experimental		Drug: Rifaximin SSD
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin SSD	Drug	Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily	Rifaximin SSD-40mg IR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first event of overt hepatic encephalopathy requiring medical intervention in hospital/ER/ED/clinic or death.		72 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to first Conn score ≥ 2 or confirmed OHE requiring medical intervention in hospital/ER/ED/clinic or death		72 weeks
Time to all-cause hospitalization		72 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
Conn (West Haven Criteria) score of < 2.
Mini-Mental State Examination (MMSE) score > 24 at screening.
≥ 18 and ≤ 85 years of age.

Key Exclusion Criteria:

Active COVID-19 that is unresolved
History of SBP
History of EVB or AKI-HRS within 6 months
History of OHE episode (Conn score ≥ 2)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Mader	Bausch Health Americas, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bausch Site 591		Homewood	Alabama	35209	United States
Bausch Site 445

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases
D001928	Brain Diseases, Metabolic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases