A 6-Month Efficacy, Safety and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
Information source: Salix Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatic Encephalopathy
Intervention: Rifaximin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Salix Pharmaceuticals
Summary
The purpose of this study is to determine if the study drug is safe and effective in
preventing Hepatic Encephalopathy (HE).
Clinical Details
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Rifaximin 550 mg BID For 6 Months In Preventing Hepatic Encephalopathy
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to treatment failure.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must sign an Informed Consent Form
- In remission from past hepatic encephalopathy (HE).
- Appropriate birth control measures
- More than or equal to 18 years of age.
- Must be potential for benefit from treatment.
- Recent prior HE episodes
- Capable and willing to comply with all study procedures.
- Subject has personal support available
- Has a certain Model End Stage Liver Disease (MELD) score
- Recent TIPS placement or revision
Exclusion Criteria:
- 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
- Subject shows presence of intestinal obstruction or has inflammatory bowel disease.
- Ongoing or recent GI bleed
Locations and Contacts
GI Specialists of Clarksville, PC, Clarksville, Tennessee 37043, United States
Additional Information
Starting date: December 2005
Last updated: May 27, 2008
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