Status:
COMPLETED
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.
Detailed Description
Eligible participants had a history of HE, a Conn score of 0 to 2 at enrollment, and either had successfully participated in a previous HE study with rifaximin (that is, RFHE3001 \[NCT00298038\]), or ...
Eligibility Criteria
Inclusion
- Must sign an Informed Consent Form
- In remission from past HE
- Appropriate birth control measures
- More than or equal to 18 years of age
- Must be potential for benefit from treatment
- Recent HE episodes
- Capable and willing to comply with all study procedures
- Participant has support network
Exclusion
- Significant medical conditions or Investigator decision not to include the participant
- Allergies to the study drug or similar drugs
- Laboratory abnormalities
- Recent participation in another clinical trial
- Problems experienced in a previous HE trial
- Pregnant or at risk of pregnancy
- Recent alcohol consumption
- Active or latent bacterial or viral Infections
- Bowel issues
- Recent Active Cancer
- On a prohibited medication
Key Trial Info
Start Date :
March 7 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2010
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT00686920
Start Date
March 7 2007
End Date
December 8 2010
Last Update
August 14 2019
Active Locations (35)
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1
Birmingham, Alabama, United States
2
Aurora, California, United States
3
Fresno, California, United States
4
La Jolla, California, United States