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We're sorry, but this trial is no longer enrolling volunteers.

"A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING,

Description

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.

Phase

N/A

Inclusion and Exclusion 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.

  • 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.

Sites

  • California

    • Salix Investigative Site, Los Angeles, California, 90033
    • Salix Investigational Site, Artesia, California, 90701
    • Salix Investigational Site, Garden Grove, California, 92840
    • Salix Investigational Site, La Jolla, California, 92093
    • Salix Investigational Site, Coronado, California, 92118
    • Salix Investigational Site, San Diego, California, 92114
    • Salix Investigational Site, Chula Vista, California, 91910
    • Salix Investigative Site, Fresno, California, 93701
  • Arizona

    • Salix Investigative Site, Scottsdale, Arizona, 85260
    • Salix Investigative Site, Tucson, Arizona, 85714
    • Salix Investigative Site, Tucson, Arizona, 85712
  • Utah

    • Salix Investigative Site, Salt Lake City, Utah, 84132
  • Oregon

    • Salix Investigational Site, Portland, Oregon, 97210
  • Colorado

    • Salix Investigational Site, Aurora, Colorado, 80045
  • Washington

    • Salix Investigative Site, Richland, Washington, 99352
    • Salix Investigative Site, Seattle, Washington, 98104
    • Salix Investigational Site, Seattle, Washington, 98122
  • Texas

    • Salix Investigational Site, San Antonio, Texas, 78215
    • Salix Investigative Site, Arlington, Texas, 76012
    • Salix Investigational Site, Dallas, Texas, 75203
    • Salix Investigative Site, Dallas, Texas, 75390
    • Salix Investigational Site, Houston, Texas, 77090
    • Salix Investigational Site, Houston, Texas, 77030
  • Illinois

    • Salix Investigative Site, Maywood, Illinois, 75390
    • Salix Investigative Site, Chicago, Illinois, 60612
  • Missouri

    • Salix Investigational Site, Kansas City, Missouri, 64131
    • Salix Investigative Site, Mexico, Missouri, 65265
    • Salix Investigative Site, St. Louis, Missouri, 63110
  • Louisiana

    • Salix Investigational Site, Shreveport, Louisiana, 71103
    • Salix Investigational Site, Monroe, Louisiana, 71201
    • Salix Investigational Site, Bastrop, Louisiana, 71220
    • Salix Investigative Site, Baton Rouge, Louisiana, 70809
    • Salix Investigational Site, New Orleans, Louisiana, 70112
  • Iowa

    • Salix Investigational Site, Des Moines, Iowa, 50309
    • Salix Investigative Site, Iowa City, Iowa, 52242
  • Minnesota

    • Salix Investigational Site, Minneapolis, Minnesota, 55455
  • Mississippi

    • Salix Investigative Site, Tupelo, Mississippi, 38801
  • New York

    • Salix Investigative Site, Brooklyn, New York, 60153
  • Alabama

    • Salix Investigative Site, Mobile, Alabama, 36617
    • Salix Investigative Site, Birmingham, Alabama, 35294
    • Salix Investigative Site, Dothan, Alabama, 36305
  • Tennessee

    • Salix Investigational Site, Nashville, Tennessee, 37205
  • Indiana

    • Salix Investigational Site, Indianapolis, Indiana, 46202
    • Salix Investigational Site, Anderson, Indiana, 46016
  • Ohio

    • Salix Investigative Site, Cincinnati, Ohio, 45224
    • Salix Investigative Site, Dayton, Ohio, 45415
  • Georgia

    • Salix Investigative Site, Atlanta, Georgia, 30342
    • Salix Investigative Site, Decatur, Georgia, 30033
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