Trial Outcomes & Findings for Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy (NCT NCT01846663)
NCT ID: NCT01846663
Last Updated: 2024-01-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
6 Months
Results posted on
2024-01-09
Participant Flow
Participant milestones
| Measure |
Rifaximin
Rifaximin, oral, 550 mg BID, 6 months of treatment
Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment
|
Placebo
Placebo, oral, 0 mg BID, 6 months of treatment
Placebo: Placebo, oral, 0 mg BID, 6 months of treatment
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Rifaximin
Rifaximin, oral, 550 mg BID, 6 months of treatment
Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment
|
Placebo
Placebo, oral, 0 mg BID, 6 months of treatment
Placebo: Placebo, oral, 0 mg BID, 6 months of treatment
|
|---|---|---|
|
Overall Study
Hepatic encephalopathy breakthrough
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
Baseline characteristics by cohort
| Measure |
Rifaximin
n=3 Participants
Rifaximin, oral, 550 mg BID, 6 months of treatment
Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment
|
Placebo
n=3 Participants
Placebo, oral, 0 mg BID, 6 months of treatment
Placebo: Placebo, oral, 0 mg BID, 6 months of treatment
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsOutcome measures
| Measure |
Rifaximin
n=3 Participants
Rifaximin, oral, 550 mg BID, 6 months of treatment
Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment
|
Placebo
n=3 Participants
Placebo, oral, 0 mg BID, 6 months of treatment
Placebo: Placebo, oral, 0 mg BID, 6 months of treatment
|
|---|---|---|
|
Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsOutcome measures
| Measure |
Rifaximin
n=3 Participants
Rifaximin, oral, 550 mg BID, 6 months of treatment
Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment
|
Placebo
n=3 Participants
Placebo, oral, 0 mg BID, 6 months of treatment
Placebo: Placebo, oral, 0 mg BID, 6 months of treatment
|
|---|---|---|
|
Proportion of Participants With HE-related Hospitalization
|
1 Participants
|
1 Participants
|
Adverse Events
Rifaximin
Serious events: 3 serious events
Other events: 2 other events
Deaths: 2 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Rifaximin
n=3 participants at risk
Rifaximin, oral, 550 mg BID, 6 months of treatment
Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment
|
Placebo
n=3 participants at risk
Placebo, oral, 0 mg BID, 6 months of treatment
Placebo: Placebo, oral, 0 mg BID, 6 months of treatment
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
66.7%
2/3 • Number of events 2 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Renal and urinary disorders
Renal failure acute
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Infections and infestations
Septic shock
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Infections and infestations
Bronchitis
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Nervous system disorders
Hepatic encephalopathy
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
Other adverse events
| Measure |
Rifaximin
n=3 participants at risk
Rifaximin, oral, 550 mg BID, 6 months of treatment
Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment
|
Placebo
n=3 participants at risk
Placebo, oral, 0 mg BID, 6 months of treatment
Placebo: Placebo, oral, 0 mg BID, 6 months of treatment
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Investigations
Ammonia increased
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Nervous system disorders
Anosmia
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Up to 6 months
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 2 • Up to 6 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Metabolism and nutrition disorders
Dyslipidemia
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
General disorders
Hypothermia
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Up to 6 months
|
|
Investigations
International normalized ratio increased
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Up to 6 months
|
|
General disorders
Edema peripheral
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
0.00%
0/3 • Up to 6 months
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 6 months
|
33.3%
1/3 • Number of events 1 • Up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor for details.
- Publication restrictions are in place
Restriction type: OTHER