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Rifaximin for Hepatic Encephalopathy (RED-C-3132 Trial)
RED-C-3132 Trial Summary
This trial will test whether rifaximin can help delay the first episode of overt hepatic encephalopathy (OHE) in people with advanced liver cirrhosis.
RED-C-3132 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRED-C-3132 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RED-C-3132 Trial Design
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Who is running the clinical trial?
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- I currently have COVID-19.I have a history of spontaneous bacterial peritonitis.You have a history of severe liver swelling (Conn score ≥ 2).Your memory and thinking skills are good, and you score more than 24 on a test called Mini-Mental State Examination (MMSE).I have liver cirrhosis with stable fluid buildup not needing fluid removal.I am between 18 and 85 years old.I have had bleeding from enlarged veins or kidney issues due to liver disease in the last 6 months.You do not have severe liver disease.You have a Conn (West Haven Criteria) score of less than 2.
- Group 1: Placebo
- Group 2: Rifaximin SSD-40mg IR
- 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
Is the age limit for this research project 25 years or older?
"This study's age requirements for participants are that they must be 18 or older, and no more than 85 years old."
Can people with the target condition participate in this research project at this time?
"Yes, the trial is still open for recruitment and recent updates to the posting on clinicaltrials.gov were made on September 22nd, 2020. The trial is looking for 466 participants total, which will be recruited from 54 different medical facilities."
Could I potentially be a candidate for this research project?
"Up to 466 patients, who are between 18-85 years old and have hepatic coma, will be accepted into this trial. In addition to meeting the age requirements, it is essential that patients also meet the followingConn (West Haven Criteria) score of < 2., ≥ 18 and ≤ 85 years of age., Key, 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)., Mini-Mental State Examination (MMSE) score > 24 at screening and"
Has Rifaximin SSD gone through the FDA's okay process?
"As this is a Phase 3 trial, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety, Rifaximin SSD is estimated to be a 3 on a scale of 1 to 3 by our team at Power."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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