5378W-13 A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY,

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF RIFAXIMIN 50MG IN SUBJECTS WITH SEVERE HEPATIC IMPAIRMENT AND OVERT HEPATIC ENCEPHALOPATHY

Type of Study
Liver - Hepatic Impairment
Short Description

The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy

Status
OPEN
Principal Investigator
Anne M Larson, MD
Eligibility Notes
  • 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
Contact Name
Terri Spinelli
Phone
206-215-3063
Alternate Phone
206-386-3660
Email
terri.spinelli@swedish.org