Phase 4
N=222
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
Hepatic Encephalopathy · Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT01842581 ↗Enrolled (actual)
222
Serious AEs
35.3%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants Reporting a First Breakthrough HE Episode — 28; 15 Participants — p=0.0359
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rifaximin (Drug); Lactulose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting a First Breakthrough HE Episode |
28; 15 | 0.0359 sig |
| SECONDARY Number of Participants Who Were Hospitalized Due to HE Episode |
23; 14 | 0.0985 |
| SECONDARY Number of Participants Who Died Due to Any Reason |
2; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01842581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.