NCT01846663TerminatedPhase 4
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy
Bausch Health Americas, Inc.25 sites in 1 country6 target enrollmentStarted: April 3, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 6
- Locations
- 25
- Primary Endpoint
- Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
Study Overview
Brief Summary
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or non-pregnant, non-breast feeding female ≥ 18 years old
- •In remission from demonstrated overt HE
- •Had ≥1 episode of overt HE associated with liver disease within the last 6 months
- •MELD score of ≥ 19
- •Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial
Exclusion Criteria
- •History of tuberculosis infection
- •Chronic respiratory insufficiency
- •Current infection and receiving antibiotics
- •Renal insufficiency requiring dialysis
- •Active spontaneous bacterial peritonitis infection
- •Intestinal obstruction or has inflammatory bowel disease
- •Active malignancy within the last 5 years
- •Current GI bleeding or has had a GI hemorrhage within past 3 months
Arms & Interventions
Placebo
Placebo Comparator
Placebo, oral, 0 mg BID, 6 months of treatment
Intervention: Placebo (Drug)
Rifaximin
Experimental
Rifaximin, oral, 550 mg BID, 6 months of treatment
Intervention: Rifaximin (Drug)
Outcomes
Primary Outcomes
Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
Time Frame: 6 Months
Secondary Outcomes
- Proportion of Participants With HE-related Hospitalization(6 Months)
Investigators
Study Sites (25)
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