Rifaximin SSD for Hepatic Coma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hepatic Coma+1 More
Rifaximin SSD - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether rifaximin can help delay the first episode of overt hepatic encephalopathy (OHE) in people with advanced liver cirrhosis.

Eligible Conditions
  • Hepatic Coma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 72 weeks

72 weeks
Time to all-cause hospitalization
Time to first event of overt hepatic encephalopathy requiring hospitalization

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Rifaximin SSD-40mg IR
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

466 Total Participants · 2 Treatment Groups

Primary Treatment: Rifaximin SSD · Has Placebo Group · Phase 3

Rifaximin SSD-40mg IR
Drug
Experimental Group · 1 Intervention: Rifaximin SSD · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin SSD
2015
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 72 weeks

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
260 Previous Clinical Trials
81,582 Total Patients Enrolled
John LaheyStudy DirectorBausch Health
5 Previous Clinical Trials
1,012 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced liver cirrhosis with medically controlled ascites (>30 days) not requiring therapeutic paracentesis (prophylactic variceal banding allowed if no history of previous variceal bleeding).
You have a mini-mental state examination score of > 24 at screening and baseline.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.