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NCT01846663 Clinical Trial

Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01846663
Other study ID # RFHE4043
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date April 3, 2013
Est. completion date February 22, 2016

Study information
Verified date January 2024
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date February 22, 2016
Est. primary completion date February 22, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo, oral, 0 mg BID, 6 months of treatment
• Rifaximin
Rifaximin, oral, 550 mg BID, 6 months treatment

Locations
Country Name City State
United States Piedmont Atlanta Hospital Atlanta Georgia
United States University of Colorado Denver Aurora Colorado
United States The University of Alabama at Birmingham Birmingham Alabama
United States Northwestern University-Comprehensive Transplant Center Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Southern California Liver Centers Coronado California
United States The Liver Institute at Methodist Dallas Medical Center Dallas Texas
United States Brook Army Medical Center Fort Sam Houston Texas
United States Salix Site Galveston Texas
United States The Methodist Hospital Houston Texas
United States UCSD Clinical & Translational Research Institute La Jolla California
United States Loma Linda University Medical Center Transplantation Institute Loma Linda California
United States Cedars-Sinai Medical Center Los Angeles California
United States University of Southern Califorina Keck School Of Medicine Los Angeles California
United States Vanderbilt University Medical Center Nashville Tennessee
United States Salix Site New Haven Connecticut
United States Tulane Abdominal Transplant Research Office New Orleans Louisiana
United States New York University School of Medicine New York New York
United States Banner Research Phoenix Arizona
United States Salix Site Portland Oregon
United States Inland Empire Liver Foundation Rialto California
United States McGuire VA Medical Center Richmond Virginia
United States VCU/MCV Health Systems Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States Washington University Saint Louis Missouri
United States Swedish Medical Center Seattle Washington
United States Salix Site Tampa Florida
United States University Of Arizona Liver Research Institute Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode 6 Months
Secondary Proportion of Participants With HE-related Hospitalization 6 Months
See also
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Not yet recruiting NCT06072521 - Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy Phase 2
Completed NCT02636647 - Fecal Transplant in Recurrent Hepatic Encephalopathy Phase 1
Withdrawn NCT02086825 - A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure Phase 3
Completed NCT01446523 - S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE N/A
Completed NCT01218568 - Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial N/A