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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05297448




Registration number
NCT05297448
Ethics application status
Date submitted
17/03/2022
Date registered
28/03/2022
Date last updated
9/05/2024

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
RNLC3132
Universal Trial Number (UTN)
Trial acronym
RED-C-3132
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
3/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
466
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Bausch Site 709 - Camperdown
Recruitment hospital [2] 0 0
Bausch Site 710 - Westmead
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bausch Health Americas, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05297448
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/NCT05297448