The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
NCT ID: NCT01842581
Last Updated: 2019-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
222 participants
INTERVENTIONAL
2013-01-08
2014-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rifaximin 550 mg BID
Participants will receive rifaximin 550 milligrams (mg) tablet orally twice daily (BID) for 24 weeks.
Rifaximin
Rifaximin will be administered per the dose and schedule specified in the arms.
Rifaximin 550 mg BID + Lactulose
Participants will receive rifaximin 550 mg tablet orally BID with lactulose solution for 24 weeks. Lactulose dose will be self-titrated by the participant to produce 2 to 3 soft stools per day.
Rifaximin
Rifaximin will be administered per the dose and schedule specified in the arms.
Lactulose
Laculose will be administered per the schedule specified in the respective arm.
Interventions
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Rifaximin
Rifaximin will be administered per the dose and schedule specified in the arms.
Lactulose
Laculose will be administered per the schedule specified in the respective arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lindsey Mathew
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Banner Research
Phoenix, Arizona, United States
Southern California Liver Centers
Coronado, California, United States
UCSF/Fresno - CRMC
Fresno, California, United States
UCSD Clinical & Translational Research Institute
La Jolla, California, United States
Salix Site
Long Beach, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Salix Site
Riverside, California, United States
Salix Site
San Diego, California, United States
Salix Site
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
South Denver GI
Englewood, Colorado, United States
University of Florida Hepatology
Gainesville, Florida, United States
Tampa General Medical Group
Tampa, Florida, United States
Gastroenterology Associates
Macon, Georgia, United States
Salix Site
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Central Iowa Hospital Corp
Des Moines, Iowa, United States
Salix Site
Jefferson, Louisiana, United States
Delta Research Partners, LLC
Monroe, Louisiana, United States
The Center for Liver and Biliary Disease
Baltimore, Maryland, United States
Brigham and Women's Hospital Division of Gastroenterology & Hepatology
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City Research Institute
Kansas City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Univ. of Nebraska Medical Center
Omaha, Nebraska, United States
Concorde Medical Group PLLC
New York, New York, United States
New York University Medical Center
New York, New York, United States
Salix Site
New York, New York, United States
Columbia University Medical Ctr. Center for Liver Disease & Transplantation
New York, New York, United States
University of Rochester Strong Memorial Hospital
Rochester, New York, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
UNC School of Medicine/Division of Gastroenterology and Hepatology
Chapel Hill, North Carolina, United States
Carolina Medical Center
Charlotte, North Carolina, United States
Integris Nazh Zuhdi Transplant Institute
Oklahoma City, Oklahoma, United States
Albert Einstien Medical Center
Philadelphia, Pennsylvania, United States
Research Specialists of Texas
Houston, Texas, United States
Amcare Research Inc
Houston, Texas, United States
Salix Site
Odessa, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
VCU/MCV Health Systems
Richmond, Virginia, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States
Countries
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References
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Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
Other Identifiers
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RFHE4044
Identifier Type: -
Identifier Source: org_study_id
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