Clinical trial NCT01842581: The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
Official title: A Multicenter, Randomized, Open-Label, Active-Controlled, Trial to Evaluate the Safety and Efficacy of Rifaximin 550 mg With and Without Lactulose in Subjects With a History of Recurrent Overt Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Cirrhosis
Keywords: Liver Failure
Hepatic Insufficiency
Liver Diseases
Brain Diseases
Rifaximin
Cirrhosis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-29
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant, non-lactating females greater than or equal to (≥) 18 years old.
* In remission from demonstrated overt HE (Conn score 0 or 1).
* Have had one or more episodes of overt HE associated with cirrhosis within 6 months prior to screening visit (Day -7 to -1).
* Participant has a close family member or other personal contact who is familiar with the participant's HE and can provide continuing oversight to the participant and is willing to perform as caregiver for the participant during the conduct of the trial.

Exclusion Criteria:

* Participant has been diagnosed with human immunodeficiency virus (HIV) as determined by medical history.
* History of tuberculosis infection.
* Participant has been diagnosed with chronic respiratory insufficiency.
* Participant has been diagnosed with a current infection for which they are currently taking oral or parenteral antibiotics.
* Renal insufficiency requiring routine dialysis.
* Participant has an active spontaneous bacterial peritonitis(SBP) infection.
* Intestinal obstruction or inflammatory bowel disease.
* Participant has active malignancy within the last 5 years prior to screening visit, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised.
* Current gastrointestinal (GI) bleeding or has a history of a GI hemorrhage of sufficient severity to require hospitalization and a transfusion of ≥2 units of blood within 3 months prior to screening visit.
* Participant is anemic, as defined by a hemoglobin of less than (\<) 8 grams/deciliter (g/dL).
* Scheduled to receive a liver transplant within 1 month of screening.

Primary outcomes:
measure: Number of Participants Reporting a First Breakthrough HE Episode
timeFrame: From randomization (Day 1) up to Day 170
Secondary outcomes:
measure: Number of Participants Who Were Hospitalized Due to HE Episode
timeFrame: From randomization (Day 1) up to Day 170
measure: Number of Participants Who Died Due to Any Reason
timeFrame: From randomization (Day 1) up to end of study (Day 186)
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From randomization (Day 1) up to end of study (Day 186)
measure: Change From Baseline in Total Chronic Liver Disease Questionnaire (CLDQ) Score at Day 170
timeFrame: Baseline, Day 170
measure: Change From Baseline in Critical Flicker Frequency (CFF) at Day 170
timeFrame: Baseline, Day 170
Locations:
city: Phoenix
country: United States
facility: Banner Research
state: Arizona
city: Coronado
country: United States
facility: Southern California Liver Centers
state: California
city: Fresno
country: United States
facility: UCSF/Fresno - CRMC
state: California
city: La Jolla
country: United States
facility: UCSD Clinical & Translational Research Institute
state: California
city: Long Beach
country: United States
facility: Salix Site
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Riverside
country: United States
facility: Salix Site
state: California
city: San Diego
country: United States
facility: Salix Site
state: California
city: San Francisco
country: United States
facility: Salix Site
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Englewood
country: United States
facility: South Denver GI
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Hepatology
state: Florida
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: Salix Site
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Des Moines
country: United States
facility: Central Iowa Hospital Corp
state: Iowa
city: Jefferson
country: United States
facility: Salix Site
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Baltimore
country: United States
facility: The Center for Liver and Biliary Disease
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital Division of Gastroenterology & Hepatology
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Omaha
country: United States
facility: Univ. of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Concorde Medical Group PLLC
state: New York
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Salix Site
state: New York
city: New York
country: United States
facility: Columbia University Medical Ctr. Center for Liver Disease & Transplantation
state: New York
city: Rochester
country: United States
facility: University of Rochester Strong Memorial Hospital
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC School of Medicine/Division of Gastroenterology and Hepatology
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Integris Nazh Zuhdi Transplant Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Albert Einstien Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: Houston
country: United States
facility: Amcare Research Inc
state: Texas
city: Odessa
country: United States
facility: Salix Site
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Richmond
country: United States
facility: VCU/MCV Health Systems
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Lindsey Mathew
role: STUDY_DIRECTOR
References: