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

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.