Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Vermont
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
Belgium
State/province [26] 0 0
Antwerpen
Country [27] 0 0
Belgium
State/province [27] 0 0
Genk
Country [28] 0 0
Belgium
State/province [28] 0 0
Gent
Country [29] 0 0
Belgium
State/province [29] 0 0
Kortrijk
Country [30] 0 0
Belgium
State/province [30] 0 0
Liege
Country [31] 0 0
Belgium
State/province [31] 0 0
Mechelen
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Ruse
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Sliven
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Sofia
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Stara Zagora
Country [36] 0 0
Canada
State/province [36] 0 0
Alberta
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
France
State/province [40] 0 0
Angers
Country [41] 0 0
France
State/province [41] 0 0
Belfort
Country [42] 0 0
France
State/province [42] 0 0
Besançon
Country [43] 0 0
France
State/province [43] 0 0
Clermont-Ferrand
Country [44] 0 0
France
State/province [44] 0 0
Limoges
Country [45] 0 0
France
State/province [45] 0 0
Lyon
Country [46] 0 0
France
State/province [46] 0 0
Nice
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
France
State/province [48] 0 0
Pessac
Country [49] 0 0
France
State/province [49] 0 0
Rennes
Country [50] 0 0
France
State/province [50] 0 0
Toulouse
Country [51] 0 0
France
State/province [51] 0 0
Vandœuvre-lès-Nancy
Country [52] 0 0
France
State/province [52] 0 0
Villejuif
Country [53] 0 0
Germany
State/province [53] 0 0
Berlin
Country [54] 0 0
Hungary
State/province [54] 0 0
Budapest
Country [55] 0 0
Hungary
State/province [55] 0 0
Debrecen
Country [56] 0 0
India
State/province [56] 0 0
Belgaum
Country [57] 0 0
India
State/province [57] 0 0
Mangaluru
Country [58] 0 0
India
State/province [58] 0 0
Nagpur
Country [59] 0 0
India
State/province [59] 0 0
Nashik
Country [60] 0 0
India
State/province [60] 0 0
Secunderabad
Country [61] 0 0
India
State/province [61] 0 0
Surat
Country [62] 0 0
Italy
State/province [62] 0 0
Milano
Country [63] 0 0
Italy
State/province [63] 0 0
Napoli
Country [64] 0 0
Italy
State/province [64] 0 0
Novara
Country [65] 0 0
Italy
State/province [65] 0 0
Palermo
Country [66] 0 0
Italy
State/province [66] 0 0
Rozzano
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Busan
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Daegu
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Daejeon
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Gangwon-do
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Goyang-si
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Gyeonggi-do
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Gyeongsang
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Seongnam-si
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Seoul
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Yongin-si
Country [77] 0 0
Mongolia
State/province [77] 0 0
Ulaan Baatar
Country [78] 0 0
New Zealand
State/province [78] 0 0
Christchurch
Country [79] 0 0
New Zealand
State/province [79] 0 0
Grafton
Country [80] 0 0
New Zealand
State/province [80] 0 0
Hamilton
Country [81] 0 0
Poland
State/province [81] 0 0
Bydgoszcz
Country [82] 0 0
Poland
State/province [82] 0 0
Katowice
Country [83] 0 0
Poland
State/province [83] 0 0
Kraków
Country [84] 0 0
Poland
State/province [84] 0 0
Myslowice
Country [85] 0 0
Poland
State/province [85] 0 0
Staszów
Country [86] 0 0
Poland
State/province [86] 0 0
Wroclaw
Country [87] 0 0
Puerto Rico
State/province [87] 0 0
Guaynabo
Country [88] 0 0
Puerto Rico
State/province [88] 0 0
San Juan
Country [89] 0 0
Spain
State/province [89] 0 0
Barcelona
Country [90] 0 0
Spain
State/province [90] 0 0
Madrid
Country [91] 0 0
Spain
State/province [91] 0 0
Málaga
Country [92] 0 0
Spain
State/province [92] 0 0
Pontevedra
Country [93] 0 0
Spain
State/province [93] 0 0
Valencia
Country [94] 0 0
Spain
State/province [94] 0 0
Zaragoza
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Dundee
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Hull
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Liverpool
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Nottingham
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Plymouth

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/ct2/show/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