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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05071716
Recruitment Status : Recruiting
First Posted : October 8, 2021
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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 advanced liver cirrhosis, defined by the presence of medically controlled ascites.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: Rifaximin SSD Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : April 7, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025


Arm Intervention/treatment
Experimental: Rifaximin SSD-40mg IR Drug: Rifaximin SSD
Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily

Placebo Comparator: Placebo Drug: Placebo
Placebo Twice Daily




Primary Outcome Measures :
  1. Time to first event of overt hepatic encephalopathy requiring hospitalization [ Time Frame: 72 weeks ]

Secondary Outcome Measures :
  1. Time to all-cause hospitalization [ Time Frame: 72 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05071716


Contacts
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Contact: Nupur Murali (609) 218-9883 nupur.murali@bauschhealth.com

Locations
Show Show 98 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: John Lahey Bausch Health
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT05071716    
Other Study ID Numbers: RNLC3131
First Posted: October 8, 2021    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents