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Study was determined to be infeasible.
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The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin | Experimental | Rifaximin, oral, 550 mg BID, 6 months of treatment |
|
| Placebo | Placebo Comparator | Placebo, oral, 0 mg BID, 6 months of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo, oral, 0 mg BID, 6 months of treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With HE-related Hospitalization | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Varsha Bhatt, Ph.D. | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294-0111 | United States | ||
| Banner Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rifaximin | Rifaximin, oral, 550 mg BID, 6 months of treatment Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment |
| FG001 | Placebo | Placebo, oral, 0 mg BID, 6 months of treatment Placebo: Placebo, oral, 0 mg BID, 6 months of treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rifaximin |
| Drug |
Rifaximin, oral, 550 mg BID, 6 months treatment |
|
|
| Phoenix |
| Arizona |
| 85016 |
| United States |
| University Of Arizona Liver Research Institute | Tucson | Arizona | 85724 | United States |
| Southern California Liver Centers | Coronado | California | 92118 | United States |
| UCSD Clinical & Translational Research Institute | La Jolla | California | 92037 | United States |
| Loma Linda University Medical Center Transplantation Institute | Loma Linda | California | 92324 | United States |
| University of Southern Califorina Keck School Of Medicine | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Salix Site | New Haven | Connecticut | 06520 | United States |
| Salix Site | Tampa | Florida | 33606 | United States |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | United States |
| Northwestern University-Comprehensive Transplant Center | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Tulane Abdominal Transplant Research Office | New Orleans | Louisiana | 70112 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Salix Site | Portland | Oregon | 97239 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212-1610 | United States |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| Brook Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Salix Site | Galveston | Texas | 77555 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| VCU/MCV Health Systems | Richmond | Virginia | 23298 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rifaximin | Rifaximin, oral, 550 mg BID, 6 months of treatment Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment |
| BG001 | Placebo | Placebo, oral, 0 mg BID, 6 months of treatment Placebo: Placebo, oral, 0 mg BID, 6 months of treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode | Posted | Count of Participants | Participants | 6 Months |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With HE-related Hospitalization | Posted | Count of Participants | Participants | 6 Months |
|
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rifaximin | Rifaximin, oral, 550 mg BID, 6 months of treatment Rifaximin: Rifaximin, oral, 550 mg BID, 6 months treatment | 2 | 3 | 3 | 3 | 2 | 3 |
| EG001 | Placebo | Placebo, oral, 0 mg BID, 6 months of treatment Placebo: Placebo, oral, 0 mg BID, 6 months of treatment | 1 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysesthesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyslipidemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| International normalized ratio increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Contact sponsor for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health Americas, Inc | 7072851528 | Varsha.Bhatt@bauschhealth.com |
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D001927 | Brain Diseases |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|