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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

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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