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Liver CirrhosisPhase 2NCT01904409

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

A Phase 2 study testing Rifaximin SSD 40 mg IR tablet, Rifaximin SSD 80 mg IR tablet and Rifaximin SSD 40 mg SER tablet in people with Liver Cirrhosis, run by Bausch Health Americas, Inc. at 120 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cirrhosis
What is being tested?
Rifaximin SSD 40 mg IR tablet, Rifaximin SSD 80 mg IR tablet and Rifaximin SSD 40 mg SER tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
120 sitesin 2 countries
Study dates
Jun 2013to Jul 2015
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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).
Show all 20Show fewer
  • 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.

Trial locations and contacts

120 sites in 2 countries.

120 sites in 2 countries

United States113 sites

  • Salix Investigational Site

    Annapolis, Maryland, 21401

  • Salix Investigative Site

    Arlington, Texas, 76012

  • Salix Investigational Site

    Artesia, California, 90701

  • Salix Investigational Site

    Asheville, North Carolina, 28801

  • Salix Investigational Site

    Atlanta, Georgia, 30309

  • Salix Investigative Site

    Atlanta, Georgia, 30342

  • Salix Investigational Site

    Austin, Texas, 78705

  • Salix Investigational Site

    Bakersfield, California, 93301

  • Salix Investigational Site

    Baltimore, Maryland, 21202

  • Salix Investigational Site

    Baltimore, Maryland, 21228

  • Salix Investigational Site

    Bastrop, Louisiana, 71220

  • Salix Investigative Site

    Birmingham, Alabama, 35294

  • Salix Investigational Site

    Boston, Massachusetts, 02114

  • Salix Investigational Site

    Boston, Massachusetts, 02115

  • Salix Investigational Site

    Bountiful, Utah, 84010

  • Salix Investigational Site

    Bowling Green, Kentucky, 42101

  • Salix Investigational Site

    Bristol, Connecticut, 06035

  • Salix Investigative Site

    Bristol, Tennessee, 37620

  • Salix Investigational Site

    Brockton, Massachusetts, 02302

  • Salix Investigative Site

    Brooklyn, New York, 60153

  • Salix Investigational Site

    Chapel Hill, North Carolina, 27599

  • Salix Investigative Site

    Charlotte, North Carolina, 28204

  • Salix Investigational Site

    Charlotte, North Carolina, 28207

  • Salix Investigational Site

    Charlottesville, Virginia, 22908

  • Salix Investigational Site

    Chattanooga, Tennessee, 37421

  • Salix Investigative Site

    Chesterfield, Michigan, 48047

  • Salix Investigational Site

    Chevy Chase, Maryland, 20815

  • Salix Investigative Site

    Chicago, Illinois, 60612

  • Salix Investigational Site

    Chula Vista, California, 91910

  • Salix Investigative Site

    Cincinnati, Ohio, 45224

  • Salix Investigational Site

    Cincinnati, Ohio, 45249

  • Salix Investigational Site

    Cleveland, Ohio, 44195

  • Salix Investigational Site

    Coral Gables, Florida, 33134

  • Salix Investigational Site

    Coronado, California, 92118

  • Salix Investigational Site

    Costa Mesa, California, 92626

  • Salix Investigational Site

    Dallas, Texas, 75203

  • Salix Investigational Site

    Dallas, Texas, 75246

  • Salix Investigative Site

    Dallas, Texas, 75390

  • Salix Investigative Site

    Dayton, Ohio, 45415

  • Salix Investigative Site

    Decatur, Georgia, 30033

  • Salix Investigative Site

    Dothan, Alabama, 36305

  • Salix Investigational Site

    Englewood, Colorado, 80113

  • Salix Investigational Site

    Evansville, Indiana, 47714

  • Salix Investigational Site

    Fayetteville, North Carolina, 28304

  • Salix Investigational Site

    Flushing, New York, 11040

  • Salix Investigational Site

    Fort Worth, Texas, 76104

  • Salix Investigative Site

    Fresno, California, 93701

  • Salix Investigational Site

    Gainesville, Florida, 32610

  • Salix Investigational Site

    Hagerstown, Maryland, 21743

  • Salix Investigative Site

    Hialeah, Florida, 33012

  • Salix Investigational Site

    Hialeah, Florida, 33016

  • Salix Investigational Site

    Hollywood, Florida, 33021

  • Salix Investigational Site

    Houston, Texas, 77005

  • Salix Investigational Site

    Houston, Texas, 77030

  • Salix Investigational Site

    Houston, Texas, 77090

  • Salix Investigational Site

    Indianapolis, Indiana, 46202

  • Salix Investigative Site

    Inverness, Florida, 34452

  • Salix Investigative Site

    Iowa City, Iowa, 52242

  • Salix Investigational Site

    Kansas City, Missouri, 64131

  • Salix Investigational Site

    La Jolla, California, 92037

  • Salix Investigational Site

    Lake Worth, Florida, 33449

  • Salix Investigative Site

    Largo, Florida, 33777

  • Salix Investigational Site

    Littleton, Colorado, 80120

  • Salix Investigative Site

    Los Angeles, California, 90033

  • Salix Investigational Site

    Macon, Georgia, 31201

  • Salix Investigative Site

    Maitland, Florida, 32751

  • Salix Investigational Site

    Marlton, New Jersey, 08053

  • Salix Investigative Site

    Maywood, Illinois, 75390

  • Salix Investigational Site

    Mentor, Ohio, 44060

  • Salix Investigational Site

    Miami, Florida, 33030

  • Salix Investigational Site

    Miami, Florida, 33126

  • Salix Investigational Site

    Miami, Florida, 33136

  • Salix Investigational Site

    Miami Springs, Florida, 33166

  • Salix Investigational Site

    Minneapolis, Minnesota, 55455

  • Salix Investigative Site

    Mobile, Alabama, 36617

  • Salix Investigational Site

    Monroe, Louisiana, 71201

  • Salix Investigational Site

    Monterey, California, 93940

  • Salix Investigational Site

    Nashville, Tennessee, 37205

  • Salix Investigational Site

    Nashville, Tennessee, 37211

  • Salix Investigational Site

    New Brunswick, New Jersey, 07102

  • Salix Investigational Site

    New Haven, Connecticut, 06520

  • Salix Investigational Site

    New Orleans, Louisiana, 70112

  • Salix Investigational Site

    New Port Richey, Florida, 34653

  • Salix Investigational Site

    New York, New York, 10016

  • Salix Investigational Site

    New York, New York, 10032

  • Salix Investigative Site

    Norfolk, Virginia, 23502

  • Salix Investigative Site

    Orlando, Florida, 32824

  • Salix Investigational Site

    Pembroke Pines, Florida, 33024

  • Salix Investigational Site

    Port Orange, Florida, 32127

  • Salix Investigational Site

    Portland, Oregon, 97210

  • Salix Investigative Site

    Richland, Washington, 99352

  • Salix Investigative Site

    Richmond, Virginia, 23249

  • Salix Investigational Site

    Richmond, Virginia, 23298

  • Salix Investigational Site

    Riverside, California, 92377

  • Salix Investigational Site

    Rochester, New York, 14642

  • Salix Investigational Site

    Saint Cloud, Florida, 34769

  • Salix Investigative Site

    Salt Lake City, Utah, 84132

  • Salix Investigational Site

    San Antonio, Texas, 78215

  • Salix Investigational Site

    San Antonio, Texas, 78229

  • Salix Investigational Site

    San Diego, California, 92114

  • Salix Investigative Site

    Seattle, Washington, 98104

  • Salix Investigational Site

    Shreveport, Louisiana, 71103

  • Salix Investigational Site

    Springfield, Massachusetts, 01105

  • Salix Investigative Site

    St Louis, Missouri, 63110

  • Salix Investigational Site

    Tamarac, Florida, 33319

  • Salix Investigative Site

    The Bronx, New York, 10467

  • Salix Investigative Site

    Tucson, Arizona, 85712

  • Salix Investigative Site

    Tupelo, Mississippi, 38801

  • Salix Investigational Site

    Ventura, California, 93003

  • Salix Investigational Site

    Waterbury, Connecticut, 06708

  • Salix Investigational Site

    Wilmington, North Carolina, 28403

  • Salix Investigational Site

    Winston-Salem, North Carolina, 27103

  • Salix Investigational Site

    Wyoming, Michigan, 49519

Other trials in United States

Russia7 sites

  • Salix Investigative Site

    Krasnogorsk

  • Salix Investigative Site

    Moscow

  • Salix Investigative Site

    Novosibirsk

  • Salix Investigative Site

    Saint Petersburg

  • Salix Investigative Site

    Samara

  • Salix Investigative Site

    Smolensk

  • Salix Investigative Site

    Stavropol

Other trials in Russia

About this study

Official title: 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.

Conditions
Liver Cirrhosis
Being tested
Placebo, Rifaximin SSD 40 mg IR tablet, Rifaximin SSD 80 mg IR tablet, Rifaximin SSD 40 mg SER tablet, Rifaximin SSD 80 mg SER tablet
Medical subject headings
Liver Cirrhosis

What participants receive

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

  • PlaceboDrug

  • Rifaximin SSD 40 mg IR tabletDrug

    Also called Rifaximin

  • Rifaximin SSD 80 mg IR tabletDrug

    Also called Rifaximin

  • Rifaximin SSD 40 mg SER tabletDrug

    Also called Rifaximin

  • Rifaximin SSD 80 mg SER tabletDrug

    Also called Rifaximin

  • Rifaximin SSD 80mgIR/80mgSER tabletDrug

    Also called Rifaximin

Study groups in NCT01904409
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo tablets once daily.
Receives: Drug: Placebo
Rifaximin SSD 40 mg IR tabletExperimentalRifaximin soluble solid dispersion (SSD) 40 mg immediate release (IR) tablet once daily.
Receives: Drug: Rifaximin SSD 40 mg IR tablet
Rifaximin SSD 80 mg IR tabletExperimentalRifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet once daily.
Receives: Drug: Rifaximin SSD 80 mg IR tablet
Rifaximin SSD 40 mg SER tabletExperimentalRifaximin soluble solid dispersion (SSD) 40 mg sustained extended release (SER) tablet once daily.
Receives: Drug: Rifaximin SSD 40 mg SER tablet
Rifaximin SSD 80 mg SER tabletExperimentalRifaximin soluble solid dispersion (SSD) 80 mg sustained extended release(SER) tablet once daily.
Receives: Drug: Rifaximin SSD 80 mg SER tablet
Rifaximin SSD 80mgIR/80mgSER tabletExperimentalRifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet + rifaximin SSD 80 mg sustained extended release (SER) tablet once daily.
Receives: Drug: Rifaximin SSD 80mgIR/80mgSER tablet

What is being measured

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

  1. Time to all-cause mortality or hospitalization that is attributable to complications of liver disease.

    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.

    Measured: Weeks 1 through 24

Secondary outcomes (6)

  1. Overall hospitalization rate due to each complication of liver disease or all-cause mortality over the 24-week treatment period.

    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.

    Measured: Weeks 1 through 24

  2. Pharmacokinetics of rifaximin and its metabolite.

    This outcome will measure the plasma levels of rifaximin and its metabolite (25-desacetyl rifaximin) for each patient during the 24-week treatment period.

    Measured: Weeks 1 through 24

  3. Incidence of treatment-emergent adverse events.

    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).

    Measured: Weeks 1 through 24

  4. Change in clinical laboratory parameters.

    This outcome will measure the changes in each patient's clinical laboratory test results during the treatment period.

    Measured: Weeks 1 through 24

  5. Changes in electrocardiogram measurements

    This outcome will measure the changes in measurements obtained from 12-lead electrocardiograms for each patient during the treatment period.

    Measured: Weeks 1 through 24

  6. Changes in indices of health outcomes

    This outcome will evaluate each patient's responses on questionnaires that assess health status.

    Measured: Weeks, 4, 8, 12, 16, and 24

Timeline

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

  1. First posted22 Jul 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2015
  4. Study completionJul 2015

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01904409
Sponsor's protocol ID
RNLC2131
Status last verified
Oct 2019
First submitted
17 Jul 2013
Last updated
23 Oct 2019
Results posted
No
Data monitoring committee
Yes

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

  • Bajaj JS, Hassanein TI, Pyrsopoulos NT, Sanyal AJ, Rahimi RS, Heimanson Z, Israel RJ, Rockey DC. Dosing of Rifaximin Soluble Solid Dispersion Tablets in Adults With Cirrhosis: 2 Randomized, Placebo-controlled Trials. Clin Gastroenterol Hepatol. 2023 Mar;21(3):723-731.e9. doi: 10.1016/j.cgh.2022.05.042. Epub 2022 Jun 22.

    PubMed 35750249

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rifaximin SSD 40 mg IR tablet, Rifaximin SSD 80 mg IR tablet and Rifaximin SSD 40 mg SER tablet in people with Liver Cirrhosis, run by Bausch Health Americas, Inc. at 120 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 4 inclusion and 20 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Russia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to all-cause mortality or hospitalization that is attributable to complications of liver disease. (time frame: Weeks 1 through 24). 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 NCT01904409, 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 23 Oct 2019.

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