Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
NCT ID: NCT03515044
Last Updated: 2023-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2018-09-13
2020-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1 40 mg Rifaximin SSD once daily
40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose
40 mg Rifaximin SSD once daily
SSD once daily (QD)
Cohort 2 40 mg Rifaximin SSD twice daily
40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose
40 mg Rifaximin SSD twice daily
SSD twice daily (BID)
Cohort 3 80 mg Rifaximin SSD once daily
80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose
80 mg Rifaximin SSD once daily
SSD once daily (QD)
Cohort 4 80 mg Rifaximin SSD twice daiy
80 mg Rifaximin sustained extended release (SER) rifaximin SSD twice daily (BID) and lactulose
80 mg Rifaximin SSD twice daily
SSD twice daily (BID)
Cohort 5 Placebo twice daily
SSD placebo twice daily (BID) and lactulose
Placebo
Administered twice daily (BID)
Interventions
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40 mg Rifaximin SSD once daily
SSD once daily (QD)
40 mg Rifaximin SSD twice daily
SSD twice daily (BID)
80 mg Rifaximin SSD once daily
SSD once daily (QD)
80 mg Rifaximin SSD twice daily
SSD twice daily (BID)
Placebo
Administered twice daily (BID)
Eligibility Criteria
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Inclusion Criteria
* Females of childbearing potential, defined as a female who is fertile following menarche, must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study.
Note: Female subjects who have been surgically sterilized (e.g., hysterectomy or bilateral tubal ligation) or who are postmenopausal (defined as total cessation of menses for \> 1 year) will not be considered "female subjects of childbearing potential".
* Subject is hospitalized with liver cirrhosis and/or OHE and has a confirmed diagnosis of OHE at Baseline.
* Subject has a Grade 2 or Grade 3 HE episode according to the HE Grading Instrument (HEGI) following 8 to 12 hours of intravenous (IV) hydration and lactulose treatment.
Exclusion Criteria
* Subject has been diagnosed with an infection for which they are currently taking oral or parenteral antibiotics, which cannot be discontinued at time of enrollment. Note: Subjects currently taking Rifaximin are not excluded
* Subject shows presence of intestinal obstruction or has inflammatory bowel disease.
* Subject has uncontrolled Type 1 or Type 2 diabetes. Note: Subjects with controlled diabetes may be enrolled if they are on stable doses of oral hypoglycemic drugs for at least 3 months prior to screening, and demonstrate clinically acceptable blood glucose control at Baseline, as determined by the investigator.
* Subject has an active malignancy (exceptions: non-melanoma skin cancers).
18 Years
75 Years
ALL
Yes
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Angela Bulawski
Role: STUDY_DIRECTOR
Bausch Health
Locations
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Bausch Health Site 18
Corona del Mar, California, United States
Bausch Health Site 15
Los Angeles, California, United States
Bausch Health Site 19
Los Angeles, California, United States
Bausch Health Site 04
San Francisco, California, United States
Bausch Health Site 13
Bristol, Connecticut, United States
Bausch Health Site 08
Miami, Florida, United States
Bausch Health Site 05
Chicago, Illinois, United States
Bausch Health Site 33
Iowa City, Iowa, United States
Bausch Health Site 03
Boston, Massachusetts, United States
Bausch Health Site 07
Detroit, Michigan, United States
Bausch Health 01
Detroit, Michigan, United States
Bausch Health Site 25
Tupelo, Mississippi, United States
Bausch Health Site 24
St Louis, Missouri, United States
Bausch Health Site 27
Newark, New Jersey, United States
Bausch Health Site 36
Brooklyn, New York, United States
Bausch Health Site 09
New York, New York, United States
Bausch Health Site 28
New York, New York, United States
Bausch Health Site 17
Cincinnati, Ohio, United States
Bausch Health Site 23
Columbus, Ohio, United States
Bausch Health Site 11
Philadelphia, Pennsylvania, United States
Bausch Health Site 26
Philadelphia, Pennsylvania, United States
Bausch Health Site 10
Philadelphia, Pennsylvania, United States
Bausch Health Site 12
Pittsburgh, Pennsylvania, United States
Bausch Health Site 16
Charleston, South Carolina, United States
Bausch Health Site 22
Dallas, Texas, United States
Bausch Health Site 35
Dallas, Texas, United States
Bausch Health Site 31
Dallas, Texas, United States
Bausch Health Site 02
Houston, Texas, United States
Bausch Health Site 37
Houston, Texas, United States
Bausch Health Site 30
Richmond, Virginia, United States
Bausch Health Site 06
Richmond, Virginia, United States
Bausch Health Site 21
Seattle, Washington, United States
Bausch Health Site 14
Seattle, Washington, United States
Bausch Health Site 20
Milwaukee, Wisconsin, United States
Countries
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References
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Bajaj JS, Hassanein TI, Pyrsopoulos NT, Sanyal AJ, Rahimi RS, Heimanson Z, Israel RJ, Rockey DC. Dosing of Rifaximin Soluble Solid Dispersion Tablets in Adults With Cirrhosis: 2 Randomized, Placebo-controlled Trials. Clin Gastroenterol Hepatol. 2023 Mar;21(3):723-731.e9. doi: 10.1016/j.cgh.2022.05.042. Epub 2022 Jun 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RNHE2041
Identifier Type: -
Identifier Source: org_study_id
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