Hepatic Encephalopathy
Conditions
Keywords
Encephalopathy, Hepatic, Portosystemic Encephalopathy, Encephalopathy, Hepatocerebral, Encephalopathy, Portal-Systemic, Encephalopathy, Portosystemic, Hepatic Coma, Hepatic Stupor, Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy
Brief summary
The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.
Interventions
DRUGRifaximin
DRUGLactulose
OTHERPlacebo
Sponsors
Bausch Health Americas, Inc.
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Cirrhosis of any cause 2. History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment 3. An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated. 4. Subject is a male or a non-pregnant and non-lactating female. Women of non-childbearing potential or who are practicing adequate birth control are eligible. The investigator is responsible for determining whether the subject has adequate birth control for study participation. 5. Subject is ≥18 years of age. 6. Subject is capable and willing to comply with all study procedures. 7. If the subject has a history of a portal-systemic shunt, shunt placement or revision must be \>6 months from Screening for TIPS or a surgical shunt.
Exclusion criteria
1. Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study. 2. Subject has a history of allergy or intolerance to lactulose. 3. Subject has a history of allergy or intolerance to rifampin or rifaximin. 4. Subject has participated in an investigational drug or device study within the 30 days prior to study screening. 5. Subject is pregnant or is lactating. 6. Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the Investigator. 7. Subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or macular degeneration) or a neurological disease beyond HE that, in the opinion of the Investigator, could impact their performance on neuropsychological assessments and psychometric tests. 8. Subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits. 9. Subject's current, required medications are on prohibited concurrent medication listing. 10. Hemoglobin \< 8.0 at time of screening 11. Severe hypovolemia or electrolyte abnormalities that would be likely to affect mental function (serum sodium less than 120 mEq/L, serum calcium greater than 11 mg/dL) at time of screening 12. Ongoing gastrointestinal bleeding at time of screening 13. Chronic renal insufficiency with a serum creatinine \> 3.0 at time of screening 14. History of tuberculosis infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Hospitalizations for Hepatic Encephalopathy (HE) | Month 7 |
| Changes in Psychometric Testing During Study Period | Month 7 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Hospitalization Days for All Causes | Month 7 |
| Death or Survival to Liver Transplantation | Month 7 |
| Rate of Adverse Events With Rifaximin Treatment | Month 7 |
Countries
United States
Participant flow
Pre-assignment details
The number of participants that were assigned to each Arm/Group is not known due to the data for this study no longer being available as the retention period has passed.
Participants by arm
| Arm | Count |
|---|---|
| Lactulose Given With a Placebo (Sugar Pill) Lactulose
Placebo | 0 |
| Lactulose Given With Rifaximin Rifaximin
Lactulose | 0 |
| Rifaximin Given Alone Rifaximin | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Changes in Psychometric Testing During Study Period
Time frame: Month 7
Population: Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.
Primary
Number of Hospitalizations for Hepatic Encephalopathy (HE)
Time frame: Month 7
Population: Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.
Secondary
Death or Survival to Liver Transplantation
Time frame: Month 7
Population: Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.
Secondary
Number of Hospitalization Days for All Causes
Time frame: Month 7
Population: Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.
Secondary
Rate of Adverse Events With Rifaximin Treatment
Time frame: Month 7
Population: Outcome measure data is not reported as the study was terminated due to difficulty with enrolling participants. Collection of data ceased and data analysis was not performed. Data collected is no longer available as the retention period has passed.