The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C-3131)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05071716
Recruitment Status : Active, not recruiting
First Posted : October 8, 2021
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE September 28, 2021
First Posted Date  ICMJE October 8, 2021
Last Update Posted Date March 22, 2024
Actual Study Start Date  ICMJE April 7, 2022
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2021)
Time to first event of overt hepatic encephalopathy requiring hospitalization [ Time Frame: 72 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2023)
  • Time to first Conn score ≥ 2 [ Time Frame: 72 weeks ]
  • Time to all-cause hospitalization [ Time Frame: 72 weeks ]
  • Time to first event of OHE that requires hospitalization, or all-cause death [ Time Frame: 72 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2021)
Time to all-cause hospitalization [ Time Frame: 72 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Hepatic Encephalopathy
Intervention  ICMJE
  • Drug: Rifaximin SSD
    Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
  • Drug: Placebo
    Placebo Twice Daily
Study Arms  ICMJE
  • Experimental: Rifaximin SSD-40mg IR
    Intervention: Drug: Rifaximin SSD
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 13, 2024)
524
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2021)
466
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05071716
Other Study ID Numbers  ICMJE RNLC3131
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Bausch Health Americas, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bausch Health Americas, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Mader Bausch Health
PRS Account Bausch Health Americas, Inc.
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP