Clinical trial NCT00686920: Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
Official title: A Multi-Center, Open-Label Trial to Evaluate the Long-Term Safety and Tolerability of Rifaximin 550 mg BID in Subjects With a History of Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatic Encephalopathy
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.

Detailed description: Eligible participants had a history of HE, a Conn score of 0 to 2 at enrollment, and either had successfully participated in a previous HE study with rifaximin (that is, RFHE3001 \[NCT00298038\]), or were new participants enrolled with ≥1 verifiable episode of HE (equivalent to a Conn score of ≥2) associated with cirrhosis or portal hypertension within 12 months of screening.

Successful participation in a previous rifaximin study was defined as having received ≥80% and ≤120% of the expected tablets, having been reasonably compliant with study procedures, and having not been discontinued from the previous study due to study drug-related Adverse Events. Participants who experienced HE or associated symptoms during or after the RFHE3001 study were considered eligible for entry into this open-label study if the participant and Investigator did not perceive study medication as a possible cause of the HE episode or associated symptoms. Participants who did not participate in a previous HE study with rifaximin were eligible if this open-label study was the only rifaximin HE study available at an individual site.

Eligibility criteria: Inclusion Criteria:

* Must sign an Informed Consent Form
* In remission from past HE
* Appropriate birth control measures
* More than or equal to 18 years of age
* Must be potential for benefit from treatment
* Recent HE episodes
* Capable and willing to comply with all study procedures
* Participant has support network

Exclusion Criteria:

* Significant medical conditions or Investigator decision not to include the participant
* Allergies to the study drug or similar drugs
* Laboratory abnormalities
* Recent participation in another clinical trial
* Problems experienced in a previous HE trial
* Pregnant or at risk of pregnancy
* Recent alcohol consumption
* Active or latent bacterial or viral Infections
* Bowel issues
* Recent Active Cancer
* On a prohibited medication

Primary outcomes:
measure: Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event
timeFrame: Baseline up to Month 36
Secondary outcomes:
measure: Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants
timeFrame: Baseline up to Month 36
measure: Number Of Participants With A Significant Mean Change From Baseline In Vital Signs
timeFrame: Baseline up to Month 36
measure: Change From Baseline In Conn Score At Last Assessment
timeFrame: Baseline up to Month 36
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Aurora
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Merced
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Golden
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Macon
country: United States
state: Georgia
city: Iowa City
country: United States
state: Iowa
city: Monroe
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Bayside
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Calgary
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Bausch Health Companies
name: Lindsey Mathew
role: STUDY_DIRECTOR
References:
citation: Mullen KD, Sanyal AJ, Bass NM, Poordad FF, Sheikh MY, Frederick RT, Bortey E, Forbes WP. Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1390-7.e2. doi: 10.1016/j.cgh.2013.12.021. Epub 2013 Dec 21.