Hepatic Encephalopathy
Conditions
Keywords
Hepatic Encephalopathy, Liver Failure, Hepatic Insufficiency, Liver Diseases, Brain Diseases, Rifaximin, Cirrhosis
Brief summary
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Interventions
DRUGPlacebo
Placebo, oral, 0 mg BID, 6 months of treatment
DRUGRifaximin
Rifaximin, oral, 550 mg BID, 6 months treatment
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant, non-breast feeding female ≥ 18 years old * In remission from demonstrated overt HE * Had ≥1 episode of overt HE associated with liver disease within the last 6 months * MELD score of ≥ 19 * Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial
Exclusion criteria
* HIV * History of tuberculosis infection * Chronic respiratory insufficiency * Current infection and receiving antibiotics * Renal insufficiency requiring dialysis * Active spontaneous bacterial peritonitis infection * Intestinal obstruction or has inflammatory bowel disease * Active malignancy within the last 5 years * Current GI bleeding or has had a GI hemorrhage within past 3 months * Anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants With HE-related Hospitalization | 6 Months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rifaximin Rifaximin, oral, 550 mg BID, 6 months of treatment
Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment | 3 |
| Placebo Placebo, oral, 0 mg BID, 6 months of treatment
Placebo: Placebo, oral, 0 mg BID, 6 months of treatment | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Hepatic encephalopathy breakthrough | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Rifaximin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 3 | 1 / 3 |
| other Total, other adverse events | 2 / 3 | 3 / 3 |
| serious Total, serious adverse events | 3 / 3 | 1 / 3 |
Outcome results
Primary
Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rifaximin | Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode | 1 Participants |
| Placebo | Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode | 1 Participants |
Secondary
Proportion of Participants With HE-related Hospitalization
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rifaximin | Proportion of Participants With HE-related Hospitalization | 1 Participants |
| Placebo | Proportion of Participants With HE-related Hospitalization | 1 Participants |