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Hepatic EncephalopathyPhase 3NCT00686920

Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy

A Phase 3 study testing Rifaximin in people with Hepatic Encephalopathy, run by Bausch Health Americas, Inc. at 35 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatic Encephalopathy
What is being tested?
Rifaximin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
322 participants
Where
35 sitesin 2 countries
Study dates
7 Mar 2007to 8 Dec 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Recent alcohol consumption
  • Active or latent bacterial or viral Infections
  • Bowel issues
  • Recent Active Cancer
  • On a prohibited medication

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States31 sites

  • Study site

    Asheville, North Carolina

  • Study site

    Aurora, California

  • Study site

    Bayside, New York

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Charlotte, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Detroit, Michigan

  • Study site

    Fresno, California

  • Study site

    Golden, Colorado

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Kansas City, Missouri

  • Study site

    La Jolla, California

  • Study site

    Lebanon, New Hampshire

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Macon, Georgia

  • Study site

    Madison, Wisconsin

  • Study site

    Merced, California

  • Study site

    Monroe, Louisiana

  • Study site

    New York, New York

  • Study site

    Odessa, Texas

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

Canada4 sites

  • Study site

    Calgary, Alberta

  • Study site

    Montreal, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Victoria, British Columbia

Other trials in Canada

About this study

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

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

Read the 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.

Being tested
Rifaximin
Medical subject headings
Hepatic Encephalopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RifaximinDrug

    Also called Xifaxan®

    Oral

Study groups in NCT00686920
Study groupRoleWhat they receive
RifaximinExperimentalParticipants from a previous rifaximin HE study and new participants were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study.
Receives: Drug: Rifaximin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event

    A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

    Measured: Baseline up to Month 36

Secondary outcomes (3)

  1. Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants

    Hematology and blood chemistry with potentially significant values included: Hemoglobin <9, >18, or ≥3 (grams/deciliter [g/dL]) decrease from previous visit or ≥4 g/dL decrease from baseline; Hematocrit <0.27%, >0.54%, or ≥0.10% decrease from previous visit or ≥0.15% decrease from baseline; Platelets <50 or >400*10^9/(liter [L]); Prothrombin time 9 seconds above baseline or upper limit of normal range; International normalized ratio >1.7; White blood cells <2.0 or >12.0*10^9/L; Lymphocytes <13.5% or >70%; Glucose, random, serum <2.2 or >16.5 millimole (mmol)/L; Potassium ≤3.0 or ≥5.5 mmol/L; Direct bilirubin increases 3-fold from baseline or >85.5 micromole (umol)/L. Baseline value was defined as the last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

    Measured: Baseline up to Month 36

  2. Number Of Participants With A Significant Mean Change From Baseline In Vital Signs

    Vital signs were measured and included sitting blood pressure, heart rate, oral temperature, and weight. These were collected at each scheduled study visit. Participants were placed supine for 5 minutes prior to each assessment of vital signs. Baseline value was defined as last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

    Measured: Baseline up to Month 36

  3. Change From Baseline In Conn Score At Last Assessment

    The assessment for change in mental status during the study was measured by the Conn score (also known as the West Haven score). The following scale was used in the Conn scoring system: Grade 0=No personality or behavioral abnormality detected. Grade 1=Trivial lack of awareness, euphoria, or anxiety; shortened attention span; or impairment of addition or subtraction. Grade 2=Lethargy; disorientation for time; obvious personality change; and inappropriate behavior. Grade 3=Somnolence to semi-stupor, responsive to stimuli; confused; gross disorientation; and bizarre behavior. Grade 4=Coma, unable to test mental state. Participants entered the study with a Conn score of 0 to 2. Baseline value was defined as last available value (including the applicable values from the participants who rolled over from Study RFHE3001) prior to the first dose of study drug.

    Measured: Baseline up to Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2008 (estimated)
  2. Study start7 Mar 2007
  3. Primary completion8 Dec 2010
  4. Study completion8 Dec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00686920
Sponsor's protocol ID
RFHE3002
Status last verified
Jul 2019
First submitted
27 May 2008
Last updated
14 Aug 2019
Data monitoring committee
No

Publications

  • Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

    PubMed 37467180

  • 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.

    PubMed 24365449

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rifaximin in people with Hepatic Encephalopathy, run by Bausch Health Americas, Inc. at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event (time frame: Baseline up to Month 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00686920, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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