Liver Cirrhosis Clinical Trial
Official title:
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
| NCT number | NCT01904409 |
| Other study ID # | RNLC2131 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | June 2013 |
| Est. completion date | July 2015 |
| Verified date | October 2019 |
| Source | Bausch Health Americas, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 420 |
| Est. completion date | July 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Salix Investigative Site | Krasnogorsk | |
| Russian Federation | Salix Investigative Site | Moscow | |
| Russian Federation | Salix Investigative Site | Novosibirsk | |
| Russian Federation | Salix Investigative Site | Petersburg | |
| Russian Federation | Salix Investigative Site | Samara | |
| Russian Federation | Salix Investigative Site | Smolensk | |
| Russian Federation | Salix Investigative Site | St. Petersburg | |
| Russian Federation | Salix Investigative Site | Stavropol | |
| United States | Salix Investigational Site | Annapolis | Maryland |
| United States | Salix Investigative Site | Arlington | Texas |
| United States | Salix Investigational Site | Artesia | California |
| United States | Salix Investigational Site | Asheville | North Carolina |
| United States | Salix Investigational Site | Atlanta | Georgia |
| United States | Salix Investigative Site | Atlanta | Georgia |
| United States | Salix Investigational Site | Austin | Texas |
| United States | Salix Investigational Site | Bakersfield | California |
| United States | Salix Investigational Site | Baltimore | Maryland |
| United States | Salix Investigational Site | Baltimore | Maryland |
| United States | Salix Investigational Site | Bastrop | Louisiana |
| United States | Salix Investigative Site | Birmingham | Alabama |
| United States | Salix Investigational Site | Boston | Massachusetts |
| United States | Salix Investigational Site | Boston | Massachusetts |
| United States | Salix Investigational Site | Bountiful | Utah |
| United States | Salix Investigational Site | Bowling Green | Kentucky |
| United States | Salix Investigational Site | Bristol | Connecticut |
| United States | Salix Investigative Site | Bristol | Tennessee |
| United States | Salix Investigational Site | Brockton | Massachusetts |
| United States | Salix Investigative Site | Bronx | New York |
| United States | Salix Investigative Site | Brooklyn | New York |
| United States | Salix Investigational Site | Chapel Hill | North Carolina |
| United States | Salix Investigational Site | Charlotte | North Carolina |
| United States | Salix Investigative Site | Charlotte | North Carolina |
| United States | Salix Investigational Site | Charlottesville | Virginia |
| United States | Salix Investigational Site | Chattanooga | Tennessee |
| United States | Salix Investigative Site | Chesterfield | Michigan |
| United States | Salix Investigational Site | Chevy Chase | Maryland |
| United States | Salix Investigative Site | Chicago | Illinois |
| United States | Salix Investigational Site | Chula Vista | California |
| United States | Salix Investigational Site | Cincinnati | Ohio |
| United States | Salix Investigative Site | Cincinnati | Ohio |
| United States | Salix Investigational Site | Cleveland | Ohio |
| United States | Salix Investigational Site | Coral Gables | Florida |
| United States | Salix Investigational Site | Coronado | California |
| United States | Salix Investigational Site | Costa Mesa | California |
| United States | Salix Investigational Site | Dallas | Texas |
| United States | Salix Investigational Site | Dallas | Texas |
| United States | Salix Investigative Site | Dallas | Texas |
| United States | Salix Investigative Site | Dayton | Ohio |
| United States | Salix Investigative Site | Decatur | Georgia |
| United States | Salix Investigative Site | Dothan | Alabama |
| United States | Salix Investigational Site | Englewood | Colorado |
| United States | Salix Investigational Site | Evansville | Indiana |
| United States | Salix Investigational Site | Fayetteville | North Carolina |
| United States | Salix Investigational Site | Flushing | New York |
| United States | Salix Investigational Site | Fort Worth | Texas |
| United States | Salix Investigative Site | Fresno | California |
| United States | Salix Investigational Site | Gainesville | Florida |
| United States | Salix Investigational Site | Hagerstown | Maryland |
| United States | Salix Investigational Site | Hialeah | Florida |
| United States | Salix Investigative Site | Hialeah | Florida |
| United States | Salix Investigational Site | Hollywood | Florida |
| United States | Salix Investigational Site | Houston | Texas |
| United States | Salix Investigational Site | Houston | Texas |
| United States | Salix Investigational Site | Houston | Texas |
| United States | Salix Investigational Site | Indianapolis | Indiana |
| United States | Salix Investigative Site | Inverness | Florida |
| United States | Salix Investigative Site | Iowa City | Iowa |
| United States | Salix Investigational Site | Kansas City | Missouri |
| United States | Salix Investigational Site | La Jolla | California |
| United States | Salix Investigational Site | Lake Worth | Florida |
| United States | Salix Investigative Site | Largo | Florida |
| United States | Salix Investigational Site | Littleton | Colorado |
| United States | Salix Investigative Site | Los Angeles | California |
| United States | Salix Investigational Site | Macon | Georgia |
| United States | Salix Investigative Site | Maitland | Florida |
| United States | Salix Investigational Site | Marlton | New Jersey |
| United States | Salix Investigative Site | Maywood | Illinois |
| United States | Salix Investigational Site | Mentor | Ohio |
| United States | Salix Investigational Site | Miami | Florida |
| United States | Salix Investigational Site | Miami | Florida |
| United States | Salix Investigational Site | Miami | Florida |
| United States | Salix Investigational Site | Miami Springs | Florida |
| United States | Salix Investigational Site | Minneapolis | Minnesota |
| United States | Salix Investigative Site | Mobile | Alabama |
| United States | Salix Investigational Site | Monroe | Louisiana |
| United States | Salix Investigational Site | Monterey | California |
| United States | Salix Investigational Site | Nashville | Tennessee |
| United States | Salix Investigational Site | Nashville | Tennessee |
| United States | Salix Investigational Site | New Brunswick | New Jersey |
| United States | Salix Investigational Site | New Haven | Connecticut |
| United States | Salix Investigational Site | New Orleans | Louisiana |
| United States | Salix Investigational Site | New Port Richey | Florida |
| United States | Salix Investigational Site | New York | New York |
| United States | Salix Investigational Site | New York | New York |
| United States | Salix Investigative Site | Norfolk | Virginia |
| United States | Salix Investigative Site | Orlando | Florida |
| United States | Salix Investigational Site | Pembroke Pines | Florida |
| United States | Salix Investigational Site | Port Orange | Florida |
| United States | Salix Investigational Site | Portland | Oregon |
| United States | Salix Investigative Site | Richland | Washington |
| United States | Salix Investigational Site | Richmond | Virginia |
| United States | Salix Investigative Site | Richmond | Virginia |
| United States | Salix Investigational Site | Riverside | California |
| United States | Salix Investigational Site | Rochester | New York |
| United States | Salix Investigational Site | Saint Cloud | Florida |
| United States | Salix Investigative Site | Saint Louis | Missouri |
| United States | Salix Investigative Site | Salt Lake City | Utah |
| United States | Salix Investigational Site | San Antonio | Texas |
| United States | Salix Investigational Site | San Antonio | Texas |
| United States | Salix Investigational Site | San Diego | California |
| United States | Salix Investigative Site | Seattle | Washington |
| United States | Salix Investigational Site | Shreveport | Louisiana |
| United States | Salix Investigational Site | Springfield | Massachusetts |
| United States | Salix Investigational Site | Tamarac | Florida |
| United States | Salix Investigative Site | Tucson | Arizona |
| United States | Salix Investigative Site | Tupelo | Mississippi |
| United States | Salix Investigational Site | Ventura | California |
| United States | Salix Investigational Site | Waterbury | Connecticut |
| United States | Salix Investigational Site | Wilmington | North Carolina |
| United States | Salix Investigational Site | Winston-Salem | North Carolina |
| United States | Salix Investigational Site | Wyoming | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. |
United States, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to all-cause mortality or hospitalization that is attributable to complications of liver disease. | The primary outcome measure will evaluate the time from start of the treatment period to death due to any cause (all-cause mortality) or hospitalization due to complications of liver disease for each patient during the 24-week treatment period. | Weeks 1 through 24 | |
| Secondary | Overall hospitalization rate due to each complication of liver disease or all-cause mortality over the 24-week treatment period. | This outcome measure will determine the rate of hospitalization (percentage of patients who are hospitalized) due to each complication of liver disease or all-cause mortality over the 24-week treatment period. | Weeks 1 through 24 | |
| Secondary | Pharmacokinetics of rifaximin and its metabolite. | This outcome will measure the plasma levels of rifaximin and its metabolite (25-desacetyl rifaximin) for each patient during the 24-week treatment period. | Weeks 1 through 24 | |
| Secondary | Incidence of treatment-emergent adverse events. | This outcome will evaluate the incidence of treatment-emergent adverse events (percentage of patients who experience adverse events following the start of the treatment period). | Weeks 1 through 24 | |
| Secondary | Change in clinical laboratory parameters. | This outcome will measure the changes in each patient's clinical laboratory test results during the treatment period. | Weeks 1 through 24 | |
| Secondary | Changes in electrocardiogram measurements | This outcome will measure the changes in measurements obtained from 12-lead electrocardiograms for each patient during the treatment period. | Weeks 1 through 24 | |
| Secondary | Changes in indices of health outcomes | This outcome will evaluate each patient's responses on questionnaires that assess health status. | Weeks, 4, 8, 12, 16, and 24 |
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