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
Description
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.
Phase
Phase 4 - refines the treatment to become part of standard care.Inclusion and Exclusion 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.
- 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.
Sites
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California
- Salix Site, Long Beach, California, 90822
- Inland Empire Liver Foundation, Rialto, California, 92377
- Salix Site, Riverside, California, 92501
- UCSD Clinical & Translational Research Institute, La Jolla, California, 92037
- Salix Site, San Diego, California, 92103
- Southern California Liver Centers, Coronado, California, 92118
- UCSF/Fresno - CRMC, Fresno, California, 93721
- Salix Site, San Francisco, California, 94115
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Arizona
- Banner Research, Phoenix, Arizona, 85016
-
Utah
- University of Utah Hospital, Salt Lake City, Utah, 84132
-
Colorado
- University of Colorado Denver, Aurora, Colorado, 80045
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Texas
- Salix Site, Odessa, Texas, 79761
- Methodist Hospital, San Antonio, Texas, 78229
- Alamo Medical Research, San Antonio, Texas, 78215
- Amcare Research Inc, Houston, Texas, 77090
- Research Specialists of Texas, Houston, Texas, 77030
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Oklahoma
- Integris Nazh Zuhdi Transplant Institute, Oklahoma City, Oklahoma, 73112
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Missouri
- Kansas City Research Institute, Kansas City, Missouri, 64131
- St. Louis University, St. Louis, Missouri, 63104
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Louisiana
- Delta Research Partners, LLC, Monroe, Louisiana, 71201
- Salix Site, Jefferson, Louisiana, 70124
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Minnesota
- Mayo Clinic, Rochester, Minnesota, 55905
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Wisconsin
- University of Wisconsin Hospital & Clinics, Madison, Wisconsin, 53792
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Illinois
- Salix Site, Chicago, Illinois, 60611
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Indiana
- Indiana University, Indianapolis, Indiana, 46202
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