Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis

October 15, 2019 updated by: Bausch Health Americas, Inc.

A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications in Subjects With Early Decompensated Liver Cirrhosis

The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis.

Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin.

Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for 24 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Krasnogorsk, Russian Federation
        • Salix Investigative Site
      • Moscow, Russian Federation
        • Salix Investigative Site
      • Novosibirsk, Russian Federation
        • Salix Investigative Site
      • Petersburg, Russian Federation
        • Salix Investigative Site
      • Samara, Russian Federation
        • Salix Investigative Site
      • Smolensk, Russian Federation
        • Salix Investigative Site
      • St. Petersburg, Russian Federation
        • Salix Investigative Site
      • Stavropol, Russian Federation
        • Salix Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Salix Investigative Site
      • Dothan, Alabama, United States, 36305
        • Salix Investigative Site
      • Mobile, Alabama, United States, 36617
        • Salix Investigative Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Salix Investigative Site
    • California
      • Artesia, California, United States, 90701
        • Salix Investigational Site
      • Bakersfield, California, United States, 93301
        • Salix Investigational Site
      • Chula Vista, California, United States, 91910
        • Salix Investigational Site
      • Coronado, California, United States, 92118
        • Salix Investigational Site
      • Costa Mesa, California, United States, 92626
        • Salix Investigational Site
      • Fresno, California, United States, 93701
        • Salix Investigative Site
      • La Jolla, California, United States, 92037
        • Salix Investigational Site
      • Los Angeles, California, United States, 90033
        • Salix Investigative Site
      • Monterey, California, United States, 93940
        • Salix Investigational Site
      • Riverside, California, United States, 92377
        • Salix Investigational Site
      • San Diego, California, United States, 92114
        • Salix Investigational Site
      • Ventura, California, United States, 93003
        • Salix Investigational Site
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Salix Investigational Site
      • Littleton, Colorado, United States, 80120
        • Salix Investigational Site
    • Connecticut
      • Bristol, Connecticut, United States, 06035
        • Salix Investigational Site
      • New Haven, Connecticut, United States, 06520
        • Salix Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Salix Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Salix Investigational Site
      • Gainesville, Florida, United States, 32610
        • Salix Investigational Site
      • Hialeah, Florida, United States, 33012
        • Salix Investigative Site
      • Hialeah, Florida, United States, 33016
        • Salix Investigational Site
      • Hollywood, Florida, United States, 33021
        • Salix Investigational Site
      • Inverness, Florida, United States, 34452
        • Salix Investigative Site
      • Lake Worth, Florida, United States, 33449
        • Salix Investigational Site
      • Largo, Florida, United States, 33777
        • Salix Investigative Site
      • Maitland, Florida, United States, 32751
        • Salix Investigative Site
      • Miami, Florida, United States, 33030
        • Salix Investigational Site
      • Miami, Florida, United States, 33126
        • Salix Investigational Site
      • Miami, Florida, United States, 33136
        • Salix Investigational Site
      • Miami Springs, Florida, United States, 33166
        • Salix Investigational Site
      • New Port Richey, Florida, United States, 34653
        • Salix Investigational Site
      • Orlando, Florida, United States, 32824
        • Salix Investigative Site
      • Pembroke Pines, Florida, United States, 33024
        • Salix Investigational Site
      • Port Orange, Florida, United States, 32127
        • Salix Investigational Site
      • Saint Cloud, Florida, United States, 34769
        • Salix Investigational Site
      • Tamarac, Florida, United States, 33319
        • Salix Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Salix Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Salix Investigative Site
      • Decatur, Georgia, United States, 30033
        • Salix Investigative Site
      • Macon, Georgia, United States, 31201
        • Salix Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Salix Investigative Site
      • Maywood, Illinois, United States, 75390
        • Salix Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Salix Investigational Site
      • Indianapolis, Indiana, United States, 46202
        • Salix Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Salix Investigative Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Salix Investigational Site
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Salix Investigational Site
      • Monroe, Louisiana, United States, 71201
        • Salix Investigational Site
      • New Orleans, Louisiana, United States, 70112
        • Salix Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • Salix Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Salix Investigational Site
      • Baltimore, Maryland, United States, 21202
        • Salix Investigational Site
      • Baltimore, Maryland, United States, 21228
        • Salix Investigational Site
      • Chevy Chase, Maryland, United States, 20815
        • Salix Investigational Site
      • Hagerstown, Maryland, United States, 21743
        • Salix Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Salix Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Salix Investigational Site
      • Brockton, Massachusetts, United States, 02302
        • Salix Investigational Site
      • Springfield, Massachusetts, United States, 01105
        • Salix Investigational Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Salix Investigative Site
      • Wyoming, Michigan, United States, 49519
        • Salix Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Salix Investigational Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Salix Investigative Site
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Salix Investigational Site
      • Saint Louis, Missouri, United States, 63110
        • Salix Investigative Site
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Salix Investigational Site
      • New Brunswick, New Jersey, United States, 07102
        • Salix Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Salix Investigative Site
      • Brooklyn, New York, United States, 60153
        • Salix Investigative Site
      • Flushing, New York, United States, 11040
        • Salix Investigational Site
      • New York, New York, United States, 10016
        • Salix Investigational Site
      • New York, New York, United States, 10032
        • Salix Investigational Site
      • Rochester, New York, United States, 14642
        • Salix Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Salix Investigational Site
      • Chapel Hill, North Carolina, United States, 27599
        • Salix Investigational Site
      • Charlotte, North Carolina, United States, 28204
        • Salix Investigative Site
      • Charlotte, North Carolina, United States, 28207
        • Salix Investigational Site
      • Fayetteville, North Carolina, United States, 28304
        • Salix Investigational Site
      • Wilmington, North Carolina, United States, 28403
        • Salix Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Salix Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45224
        • Salix Investigative Site
      • Cincinnati, Ohio, United States, 45249
        • Salix Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Salix Investigational Site
      • Dayton, Ohio, United States, 45415
        • Salix Investigative Site
      • Mentor, Ohio, United States, 44060
        • Salix Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Salix Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Salix Investigative Site
      • Chattanooga, Tennessee, United States, 37421
        • Salix Investigational Site
      • Nashville, Tennessee, United States, 37205
        • Salix Investigational Site
      • Nashville, Tennessee, United States, 37211
        • Salix Investigational Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Salix Investigative Site
      • Austin, Texas, United States, 78705
        • Salix Investigational Site
      • Dallas, Texas, United States, 75203
        • Salix Investigational Site
      • Dallas, Texas, United States, 75246
        • Salix Investigational Site
      • Dallas, Texas, United States, 75390
        • Salix Investigative Site
      • Fort Worth, Texas, United States, 76104
        • Salix Investigational Site
      • Houston, Texas, United States, 77030
        • Salix Investigational Site
      • Houston, Texas, United States, 77005
        • Salix Investigational Site
      • Houston, Texas, United States, 77090
        • Salix Investigational Site
      • San Antonio, Texas, United States, 78215
        • Salix Investigational Site
      • San Antonio, Texas, United States, 78229
        • Salix Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Salix Investigational Site
      • Salt Lake City, Utah, United States, 84132
        • Salix Investigative Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Salix Investigational Site
      • Norfolk, Virginia, United States, 23502
        • Salix Investigative Site
      • Richmond, Virginia, United States, 23249
        • Salix Investigative Site
      • Richmond, Virginia, United States, 23298
        • Salix Investigational Site
    • Washington
      • Richland, Washington, United States, 99352
        • Salix Investigative Site
      • Seattle, Washington, United States, 98104
        • Salix Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of liver cirrhosis and documented ascites.
  • Model End Stage Liver Disease (MELD) score of at least 12, MELD Na of at least 12, or Child-Pugh B (score of 7 - 9).
  • If applicable, has a close family or other personal contacts who can provide continuing oversight to the patient and will be available to the patient during the conduct of the trial.
  • If female of childbearing potential, have a negative serum pregnancy test at study start and agree to use an acceptable method of contraception during the study.

Exclusion Criteria:

  • History of a major psychiatric disorder including uncontrolled major depression or controlled or uncontrolled psychoses within the past 24 months prior to study start.
  • History of alcohol abuse or substance abuse within the past 3 months prior to study start.
  • Documented cholestatic liver disease such as primary sclerosing cholangitis.
  • Had prophylactic variceal banding within 2 weeks or is scheduled to undergo prophylactic banding during the study.
  • Diagnosed with an infection for which the patient is currently taking oral or parenteral antibiotics.
  • Significant hypovolemia, or any electrolyte abnormality that can affect mental function (eg, serum sodium < 125 mEq/L, serum calcium > 10 mg/dL).
  • Severe hypokalemia, defined as serum potassium concentration < 2.5 mEq/L.
  • Anemic, defined as hemoglobin concentration ≤ 8 g/dL.
  • Renal insufficiency with a creatinine of ≥ 1.5 mg/dL.
  • Presence of intestinal obstruction or inflammatory bowel disease.
  • Uncontrolled Type 1 or Type 2 diabetes.
  • History of seizure disorders.
  • Unstable cardiovascular or pulmonary disease, categorized by a worsening in the disease condition that requires a change in treatment or medical care within 30 days of study start.
  • Active malignancy within the last 5 years (exceptions: basal cell carcinomas of the skin, or if female, in situ cervical carcinoma that has been surgically excised).
  • Has hepatocellular carcinoma.
  • Known human immunodeficiency virus, varicella, herpes zoster, or other severe viral infection within 6 weeks of study start.
  • Positive stool test for Yersinia enterocolitica, Campylobacter jejuni, Salmonella, Shigella, ovum and parasites, and/or Clostridium difficile (C. difficile); determined during the screening period prior to study start.
  • History of tuberculosis infection and/or has received treatment for a tuberculosis infection.
  • History of hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of rifaximin soluble solid dispersion.
  • Used any investigational product or device, or participated in another research study within 30 days prior to study start.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo tablets once daily.
Drug: Placebo
Experimental: Rifaximin SSD 40 mg IR tablet
Rifaximin soluble solid dispersion (SSD) 40 mg immediate release (IR) tablet once daily.
Drug: Rifaximin SSD 40 mg IR tablet
Other Names:
  • Rifaximin
Experimental: Rifaximin SSD 80 mg IR tablet
Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet once daily.
Drug: Rifaximin SSD 80 mg IR tablet
Other Names:
  • Rifaximin
Experimental: Rifaximin SSD 40 mg SER tablet
Rifaximin soluble solid dispersion (SSD) 40 mg sustained extended release (SER) tablet once daily.
Drug: Rifaximin SSD 40 mg SER tablet
Other Names:
  • Rifaximin
Experimental: Rifaximin SSD 80 mg SER tablet
Rifaximin soluble solid dispersion (SSD) 80 mg sustained extended release(SER) tablet once daily.
Drug: Rifaximin SSD 80 mg SER tablet
Other Names:
  • Rifaximin
Experimental: Rifaximin SSD 80mgIR/80mgSER tablet
Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet + rifaximin SSD 80 mg sustained extended release (SER) tablet once daily.
Drug: Rifaximin SSD 80mgIR/80mgSER tablet
Other Names:
  • Rifaximin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to all-cause mortality or hospitalization that is attributable to complications of liver disease.
Time Frame: Weeks 1 through 24
The primary outcome measure will evaluate the time from start of the treatment period to death due to any cause (all-cause mortality) or hospitalization due to complications of liver disease for each patient during the 24-week treatment period.
Weeks 1 through 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall hospitalization rate due to each complication of liver disease or all-cause mortality over the 24-week treatment period.
Time Frame: Weeks 1 through 24
This outcome measure will determine the rate of hospitalization (percentage of patients who are hospitalized) due to each complication of liver disease or all-cause mortality over the 24-week treatment period.
Weeks 1 through 24
Pharmacokinetics of rifaximin and its metabolite.
Time Frame: Weeks 1 through 24
This outcome will measure the plasma levels of rifaximin and its metabolite (25-desacetyl rifaximin) for each patient during the 24-week treatment period.
Weeks 1 through 24
Incidence of treatment-emergent adverse events.
Time Frame: Weeks 1 through 24
This outcome will evaluate the incidence of treatment-emergent adverse events (percentage of patients who experience adverse events following the start of the treatment period).
Weeks 1 through 24
Change in clinical laboratory parameters.
Time Frame: Weeks 1 through 24
This outcome will measure the changes in each patient's clinical laboratory test results during the treatment period.
Weeks 1 through 24
Changes in electrocardiogram measurements
Time Frame: Weeks 1 through 24
This outcome will measure the changes in measurements obtained from 12-lead electrocardiograms for each patient during the treatment period.
Weeks 1 through 24
Changes in indices of health outcomes
Time Frame: Weeks, 4, 8, 12, 16, and 24
This outcome will evaluate each patient's responses on questionnaires that assess health status.
Weeks, 4, 8, 12, 16, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: James Joffrion, Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNLC2131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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