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The Safety/Efficacy Of Rifaximin With/Without Lactulose In Subjects With A History Of Recurrent Hepatic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01842581
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : April 27, 2017
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
The purpose of the study is to evaluate if Rifaximin alone or Rifaximin plus Lactulose delays the onset of hepatic encephalopathy (HE) in cirrhotic subjects who have had a previous episode of HE.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Cirrhosis Drug: Rifaximin Drug: Rifaximin and Lactulose Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-Label, Active-Controlled, Trial To Evaluate The Safety And Efficacy Of Rifaximin 550 Mg With And Without Lactulose In Subjects With A History Of Recurrent Overt Hepatic Encephalopathy
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Rifaximin
550 mg tablet BID
Drug: Rifaximin
Other Name: Xifaxan

Experimental: Rifaximin and Lactulose
Rifaximin 550 mg tablet BID plus lactulose
Drug: Rifaximin and Lactulose

Primary Outcome Measures :
  1. Time to first breakthrough HE episode [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Time to first HE-related hospitalization [ Time Frame: 6 Months ]
  2. All Cause Mortality [ Time Frame: 6 Months ]

Other Outcome Measures:
  1. Adverse Events [ Time Frame: 6 Months ]
  2. Assessment of quality of life [ Time Frame: 6 Months ]
  3. Laboratory Parameters (changes in hematology, blood chemistry, and urinalysis test results) [ Time Frame: 6 Months ]
  4. Vital Signs (Changes in blood pressure and heart rate) [ Time Frame: 6 Months ]
  5. Electrocardiograms (12 lead ECG findings) [ Time Frame: 6 months ]
  6. Neurologic Function (The critical flicker frequency (CFF) test). [ Time Frame: 6 Months ]
    The CFF is the frequency at which the subject observes a constant light transition to a flickering light and will be measured in Hertz (Hz).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and non-pregnant, non-lactating females >/= 18 years
  • In remission from demonstrated overt HE
  • Have had one or more episodes of overt HE associated with cirrhosis in the last 6 months
  • Subject has a close family member or other personal contact who is familiar with the subject's HE and can provide continuing oversight to the subject and is willing to perform as caregiver during the conduct of the trial

Exclusion Criteria:

  • HIV
  • History of Tuberculosis infection
  • Chronic respiratory insufficiency
  • Current infection and receiving antibiotics
  • Renal insufficiency requiring dialysis
  • Active spontaneous bacterial peritonitis infection
  • Intestinal obstruction or inflammatory bowel disease
  • Active malignancy within the last 5 years
  • Current GI bleeding or has a history of a GI hemorrhage (within last 3 months
  • Anemia
  • Scheduled to receive a liver transplant within 1 month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01842581

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Sponsors and Collaborators
Bausch Health Americas, Inc.
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Study Director: Enoch Bortey, Ph.D. Bausch Health Americas, Inc.

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Responsible Party: Bausch Health Americas, Inc. Identifier: NCT01842581     History of Changes
Other Study ID Numbers: RFHE4044
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Bausch Health Americas, Inc.:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Brain Diseases

Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents