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

Completed · Phase 2 · Has a placebo group

Conditions studied: Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT01904409

Run by

Bausch Health Americas, Inc.

People needed

420

Starts

2013-06-01

Expected to finish

2015-07-01

Last updated by the study team

2019-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Salix Investigative Site — Dothan, Alabama, United States
• Salix Investigative Site — Mobile, Alabama, United States
• Salix Investigative Site — Tucson, Arizona, United States
• Salix Investigational Site — Artesia, California, United States
• Salix Investigational Site — Bakersfield, California, United States
• Salix Investigational Site — Chula Vista, California, United States
• Salix Investigational Site — Coronado, California, United States
• Salix Investigational Site — Costa Mesa, California, United States
• Salix Investigative Site — Fresno, California, United States
• Salix Investigational Site — La Jolla, California, United States
• Salix Investigative Site — Los Angeles, California, United States
• Salix Investigational Site — Monterey, California, United States
• Salix Investigational Site — Riverside, California, United States
• Salix Investigational Site — San Diego, California, United States
• Salix Investigational Site — Ventura, California, United States
• Salix Investigational Site — Englewood, Colorado, United States
• Salix Investigational Site — Littleton, Colorado, United States
• Salix Investigational Site — Bristol, Connecticut, United States
• Salix Investigational Site — New Haven, Connecticut, United States
• Salix Investigational Site — Waterbury, Connecticut, United States
• Salix Investigational Site — Coral Gables, Florida, United States
• Salix Investigational Site — Gainesville, Florida, United States
• Salix Investigative Site — Hialeah, Florida, United States
• Salix Investigational Site — Hialeah, Florida, United States
• Salix Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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