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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05071716




Registration number
NCT05071716
Ethics application status
Date submitted
28/09/2021
Date registered
8/10/2021
Date last updated
22/03/2024

Titles & IDs
Public title
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Secondary ID [1] 0 0
RNLC3131
Universal Trial Number (UTN)
Trial acronym
RED-C-3131
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatic Encephalopathy 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rifaximin SSD
Treatment: Drugs - Placebo

Experimental: Rifaximin SSD-40mg IR -

Placebo comparator: Placebo -


Treatment: Drugs: Rifaximin SSD
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

Treatment: Drugs: Placebo
Placebo Twice Daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first event of overt hepatic encephalopathy requiring hospitalization
Timepoint [1] 0 0
72 weeks
Secondary outcome [1] 0 0
Time to first Conn score = 2
Timepoint [1] 0 0
72 weeks
Secondary outcome [2] 0 0
Time to all-cause hospitalization
Timepoint [2] 0 0
72 weeks
Secondary outcome [3] 0 0
Time to first event of OHE that requires hospitalization, or all-cause death
Timepoint [3] 0 0
72 weeks

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
Accrual to date
Final
524
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Bausch Site 307 - Concord
Recruitment hospital [2] 0 0
Bausch Site 300 - Kingswood
Recruitment hospital [3] 0 0
Bausch Site 306 - Bedford Park
Recruitment hospital [4] 0 0
Bausch Site 304 - Box Hill
Recruitment hospital [5] 0 0
Bausch Site 302 - Parkville
Recruitment hospital [6] 0 0
Bausch Site 305 - Murdoch
Recruitment hospital [7] 0 0
Bausch Site 303 - Perth
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2750 - Kingswood
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
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Alabama
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Arizona
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Mississippi
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Missouri
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New Mexico
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North Carolina
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Wisconsin
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Canada
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Alberta
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Canada
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Ontario
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Puerto Rico
State/province [37] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bausch Health Americas, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05071716
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Mader
Address 0 0
Bausch Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05071716