Status:
COMPLETED
A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).
Eligibility Criteria
Inclusion
- Must sign an Informed Consent Form
- In remission from past HE
- Uses appropriate birth control measures
- More than or equal to 18 years of age
- Must have potential to benefit from treatment
- Recent prior HE episodes
- Capable and willing to comply with all study procedures
- Participant has personal support available
- Has a certain Model End Stage Liver Disease (MELD) score
- Recent transjugular intrahepatic portosystemic shunt (TIPS) placement or revision
Exclusion
- Significant medical conditions, medical conditions that may impact study participation, or Investigator decision not to include
- Allergies to the study drug or similar drugs
- Laboratory abnormalities
- Recent participation in another clinical trial
- History of non-compliance
- Pregnant or at risk of pregnancy, or is lactating
- Recent alcohol consumption
- Active bacterial or viral Infections
- Bowel issues
- Active malignancy
- On a prohibited medication
- Liver transplant expected in near term
- Lactulose intolerance
- Participant shows presence of intestinal obstruction or has inflammatory bowel disease
- Ongoing or recent GI bleed
Key Trial Info
Start Date :
December 19 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2008
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT00298038
Start Date
December 19 2005
End Date
August 15 2008
Last Update
September 18 2019
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