Status:
COMPLETED
Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT01904409
Start Date
June 1 2013
End Date
July 1 2015
Last Update
October 23 2019
Active Locations (120)
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1
Salix Investigative Site
Birmingham, Alabama, United States, 35294
2
Salix Investigative Site
Dothan, Alabama, United States, 36305
3
Salix Investigative Site
Mobile, Alabama, United States, 36617
4
Salix Investigative Site
Tucson, Arizona, United States, 85712