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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.
- Liver Encephalopathy
RED-C-3131 Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
RED-C-3131 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
RED-C-3131 Trial Design
Find a Location
Who is running the clinical trial?
- Have you been diagnosed with liver cirrhosis?Do you have a history of substance abuse in the last 6 months?How many alcoholic drinks do you have per day?Are you currently enrolled in another clinical trial or have participated in one in the last 30 days?What is the potential participant's sex (assigned at birth)?Are you between the ages of 18 and 85 years old?Have you used or are currently using Rifaximin and/or lactulose for the treatment of hepatic encephalopathy?
- Group 1: Rifaximin SSD-40mg IR
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Would this particular medication testing be open to elderly participants?
"Eligibility criteria for this clinical trial includes being between 18-85 years old."
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."
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."
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."
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."
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."
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."
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, Massachusettst New Mexico VA Healthcare System. Out of the 18,333 completed trials, 28 are still ongoing with many taking place in Burlington, Massachusetts."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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