The Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
Overview[ - collapse ][ - ]
| Purpose | The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy. |
|---|---|
| Condition | Hepatic Encephalopathy |
| Intervention | Drug: Placebo Drug: Rifaximin |
| Phase | Phase 4 |
| Sponsor | Salix Pharmaceuticals |
| Responsible Party | Salix Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT01846663 |
| First Received | April 24, 2013 |
| Last Updated | April 9, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 24, 2013 |
|---|---|
| Last Updated Date | April 9, 2014 |
| Start Date | April 2013 |
| Estimated Primary Completion Date | December 2014 |
| Current Primary Outcome Measures | Time to first Hepatic Encephalopathy(HE) breakthrough episode [Time Frame: 6 Months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | The Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy |
|---|---|
| Official Title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Hepatic Encephalopathy |
| Intervention | Drug: Placebo Placebo, oral, 0 mg BID, 6 months of treatment Drug: Rifaximin Rifaximin, oral, 550 mg BID, 6 months treatment Other Names: XIFAXAN® Tablets |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 100 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | July 2014 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Erica Bullock 919-862-1854 erica.bullock@salix.com |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01846663 |
|---|---|
| Other Study ID Numbers | RFHE4043 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Salix Pharmaceuticals |
| Study Sponsor | Salix Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Study Director: Enoch Bortey, Ph.D. Salix Pharmaceuticals |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| The University of Alabama at Birmingham | Birmingham, Alabama, United States, 35294-0111 Contact: Megan Pickering | 205-934-1224Principal Investigator: Brendan McGuire, MD Recruiting |
|---|---|
| Banner Research | Phoenix, Arizona, United States, 85016 Contact: Kelly Enders | 602-839-6211Principal Investigator: Ester Little, MD Recruiting |
| University Of Arizona Liver Research Institute | Tuscon, Arizona, United States, 85724 Contact: Julie Johnson | 520-626-1208Principal Investigator: Shahid Habib, MD Recruiting |
| Southern California Liver Centers | Coronado, California, United States, 92118 Contact: Monson Petrea | 619-522-0330222Principal Investigator: Tarek Hassanein, MD Recruiting |
| UCSD Clinical & Translational Research Institute | Lajolla, California, United States, 92037 Contact: Sharon Quigley | 858-657-5147Principal Investigator: Michael Mendler, MD Recruiting |
| Loma Linda University Medical Center Transplantation Institute | Loma Linda, California, United States, 92324 Contact: Diane Scavone | 909-558-363633634Principal Investigator: Thomas Amankonah, MD Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States, 90048 Contact: Jennifer Luckett | 310-423-5453Principal Investigator: Vinay Sundaram, MD Recruiting |
| University of Southern Califorina Keck School Of Medicine | Los Angeles, California, United States, 90033 Contact: Pui Yan | 323-442-8152Principal Investigator: Linda Sher, MD Recruiting |
| University of Colorado Denver | Aurora, Colorado, United States, 80045 Contact: Haley Isberg | 303-724-6559Principal Investigator: Lisa Forman, MD Recruiting |
| Salix Site | New Haven, Connecticut, United States, 06520 Terminated |
| Salix Site | Tampa, Florida, United States, 33606 Not yet recruiting |
| Piedmont Atlanta Hospital | Atlanta, Georgia, United States, 30309 Contact: Becky Slawik | 404-605-3212Principal Investigator: Lance Stein, MD Recruiting |
| Northwestern University-Comprehensive Transplant Center | Chicago, Illinois, United States, 60611 Contact: Grace Rivera | 312-926-0658Principal Investigator: Josh Levitsky, MD Recruiting |
| Rush University Medical Center | Chicago, Illinois, United States, 60612 Contact: Diana Giczewski | 312-563-3919Principal Investigator: Nikunj Shah, MD Recruiting |
| Tulane Abdominal Transplant Research Office | New Orleans, Louisiana, United States, 70112 Contact: Joni Murray | 504-988-6902Principal Investigator: Luis Balart, MD Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States, 55905 Contact: Linda Stadheim | 507-284-0141Principal Investigator: Michael Leise, MD Recruiting |
| Washington University | St. Louis, Missouri, United States, 63110 Contact: Debra Kemp | 314-362-3839Principal Investigator: Jackie Fleckenstein, MD Recruiting |
| New York University School of Medicine | New York, New York, United States, 10016 Contact: Christelle Sommervil | 212-263-8391Principal Investigator: Lewis Teperman, MD Recruiting |
| Salix Site | Portland, Oregon, United States, 97239 Not yet recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee, United States, 37212-1610 Contact: Tonya Givens | 615-936-1745Principal Investigator: Michael Porayko, MD Recruiting |
| The Liver Institute at Methodist Dallas Medical Center | Dallas, Texas, United States, 75203 Contact: Zena Cooper | 214-947-4463Principal Investigator: Parvez Mantry, MD Recruiting |
| Brook Army Medical Center | Fort Sam Houston, Texas, United States, 78234 Contact: Karol Barstow | 210-916-4811Principal Investigator: Stephen Harrison, MD Recruiting |
| Salix Site | Galveston, Texas, United States, 77555 Terminated |
| The Methodist Hospital | Houston, Texas, United States, 77030 Contact: Susan Dorman | 713-441-6316Principal Investigator: Howard Monsour, Jr., MD Recruiting |
| VCU/MCV Health Systems | Richmond, Virginia, United States, 23298 Contact: Stephanie Taylor, RN | 804-828-9311Principal Investigator: Arun Sanyal, MD Recruiting |
| Swedish Medical Center | Seattle, Washington, United States, 98122 Contact: Terri Spinelli | 206-215-3063Principal Investigator: Anne Larson, MD Recruiting |