Status:
COMPLETED
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Hepatic Encephalopathy
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2014
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT01842581
Start Date
January 8 2013
End Date
December 17 2014
Last Update
September 9 2019
Active Locations (43)
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1
Banner Research
Phoenix, Arizona, United States, 85016
2
Southern California Liver Centers
Coronado, California, United States, 92118
3
UCSF/Fresno - CRMC
Fresno, California, United States, 93721
4
UCSD Clinical & Translational Research Institute
La Jolla, California, United States, 92037