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Antibiotic

Rifaximin SSD for Encephalopathy (RED-C-3131 Trial)

Phase 3
Waitlist Available
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you between the ages of 18 and 85 years old?
Have you been diagnosed with liver cirrhosis?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights

RED-C-3131 Trial Summary

This trial is testing whether a drug can help prevent hepatic encephalopathy, a complication of liver cirrhosis, in people who have not had it before.

Who is the study for?
This trial is for adults aged 18-85 with liver cirrhosis who haven't had an overt hepatic encephalopathy episode yet. Participants should not have a recent history of substance abuse, excessive alcohol consumption, or be in another clinical study. They must not have used Rifaximin or lactulose for hepatic encephalopathy before.Check my eligibility
What is being tested?
The study is testing if a new form of the drug Rifaximin (40mg SSD) can prevent worsening brain function problems in people with liver cirrhosis compared to a placebo. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug.See study design
What are the potential side effects?
While specific side effects are not listed here, Rifaximin may commonly cause gastrointestinal symptoms like nausea or create an environment where resistant bacteria can grow.

RED-C-3131 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

RED-C-3131 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first event of overt hepatic encephalopathy requiring hospitalization
Secondary outcome measures
Time to all-cause hospitalization
Time to first Conn score ≥ 2
Time to first event of OHE that requires hospitalization, or all-cause death

RED-C-3131 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rifaximin SSD-40mg IRExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin SSD
2015
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,562 Total Patients Enrolled
John LaheyStudy DirectorBausch Health
5 Previous Clinical Trials
1,012 Total Patients Enrolled
Michael MaderStudy DirectorBausch Health
1 Previous Clinical Trials
466 Total Patients Enrolled

Media Library

Rifaximin SSD (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05071716 — Phase 3
Encephalopathy Research Study Groups: Placebo, Rifaximin SSD-40mg IR
Encephalopathy Clinical Trial 2023: Rifaximin SSD Highlights & Side Effects. Trial Name: NCT05071716 — Phase 3
Rifaximin SSD (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05071716 — Phase 3
Encephalopathy Patient Testimony for trial: Trial Name: NCT05071716 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this particular medication testing be open to elderly participants?

"Eligibility criteria for this clinical trial includes being between 18-85 years old."

Answered by AI

Are we still looking for new participants in this experiment?

"That is correct. The most recent update on clinicaltrials.gov shows that this trial was last updated on 9/22/2022 and is actively recruiting patients. In total, 466 patients are needed for the study which will take place at 91 sites."

Answered by AI

Where are patients able to participate in this trial?

"Currently, 91 locations are running this study. Some examples of these clinical trial sites include Bausch Site 146 in Burlington, Bausch Site 189 in Los Angeles, and Bausch Site 127 in Murray."

Answered by AI

Are there any recorded side effects of Rifaximin SSD?

"There is some clinical data to support the efficacy of Rifaximin SSD and it has been tested for safety multiple times, so it received a score of 3."

Answered by AI

How can I sign up for this opportunity to help with this research?

"This study requires potential participants to have hepatic coma and be between 18-85 years old. There is space for 466 patients in total."

Answered by AI

What are the main conditions that Rifaximin SSD is used to treat?

"Rifaximin SSD is most commonly used to prevent Clostridium difficile infection recurrence, but it can also be taken as a treatment for irritable bowel syndrome (IBS), bacterial infections, and diarrhea."

Answered by AI

How many people fit the requirements for this clinical trial?

"The sponsor, Bausch Health Americas, Inc., needs 466 eligible patients to proceed with the study. They will be conducting clinical trials at different sites including Bausch Site 146 in Burlington, Massachusetts and Bausch Site 189 in Los Angeles, California."

Answered by AI

What other scientific investigations have utilized Rifaximin SSD?

"The Rifaximin SSD was first studied in 2009 at New mexico VA Healthcare System. Out of the 18,333 completed trials, 28 are still ongoing with many taking place in Burlington, Massachusetts."

Answered by AI

Who else is applying?

What state do they live in?
California
South Carolina
Massachusetts
Other
What site did they apply to?
Bausch Site 129
Bausch Site 143
Bausch Site 132
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've been wanting to try something for my liver. I hope the study will enlighten me of my condition.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
2022. "Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05071716.
~116 spots leftby Jan 2025
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