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Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C-3132)

Primary Purpose

Hepatic Encephalopathy

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rifaximin SSD
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Encephalopathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of advanced liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (prophylactic variceal banding allowed if no history of previous variceal bleeding).
  • Conn (West Haven Criteria) score of < 2.
  • Mini-Mental State Examination (MMSE) score > 24 at screening and baseline.
  • ≥ 18 and ≤ 85 years of age.

Key Exclusion Criteria:

  • Active COVID-19, history of SBP, EVP or AKI-HRS
  • History of OHE episode (Conn score ≥ 2)
  • Use, among others, non-study rifaximin, lactulose/lactitol (with exception of prior occasional, intermittent use of lactulose for non-OHE indications), benzodiazepine, and chronic antibiotics.

Sites / Locations

  • Bausch Site 543Recruiting
  • Bausch Site 552Recruiting
  • Bausch Site 537Recruiting
  • Bausch Site 531Recruiting
  • Bausch Site 519Recruiting
  • Bausch Site Heritage Medical Research Clinic
  • Bausch Site University of Alberta Hospital
  • Bausch Site G.I.R.I. GI Research Institute
  • Bausch Site Barrie GI Associates
  • Bausch Site Brampton Civic Hospital
  • Bausch Site McMaster University Medical Centre - Hamilton Health Services
  • Bausch Site Albany Medical Clinic
  • Bausch Site Toronto General Hospital
  • Bausch Site: Pharmaceutical Integrated Research Corporation
  • Bausch Site Clinique Medicale L'Actuel
  • Bausch Site: CHUM Centre de Recherche
  • Bausch Site DIEX Recherche Quebec Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rifaximin SSD-40mg IR

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time to first event of overt hepatic encephalopathy requiring hospitalization

Secondary Outcome Measures

Time to first Conn score ≥ 2
Time to all-cause hospitalization
Time to first event of OHE that requires hospitalization, or all-cause death

Full Information

First Posted
March 17, 2022
Last Updated
April 7, 2023
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05297448
Brief Title
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Acronym
RED-C-3132
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
466 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin SSD-40mg IR
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rifaximin SSD
Intervention Description
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Twice Daily
Primary Outcome Measure Information:
Title
Time to first event of overt hepatic encephalopathy requiring hospitalization
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Time to first Conn score ≥ 2
Time Frame
72 weeks
Title
Time to all-cause hospitalization
Time Frame
72 weeks
Title
Time to first event of OHE that requires hospitalization, or all-cause death
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nupur Murali
Phone
6092189883
Email
nupur.murali@bauschhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Mader
Organizational Affiliation
Bausch Health
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 543
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 552
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 537
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 531
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 519
City
Denison
State/Province
Texas
ZIP/Postal Code
75929
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site G.I.R.I. GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site Barrie GI Associates
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site Brampton Civic Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site McMaster University Medical Centre - Hamilton Health Services
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site Albany Medical Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0A9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site: Pharmaceutical Integrated Research Corporation
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site Clinique Medicale L'Actuel
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site: CHUM Centre de Recherche
City
Montreal
State/Province
Quebec
ZIP/Postal Code
HSX 0A9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bausch Site DIEX Recherche Quebec Inc.
City
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

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