Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

Completed · Phase 2 · Has a placebo group

Conditions studied: Overt Hepatic Encephalopathy

In brief

Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).

Key facts

Study ID

NCT03515044

Run by

Bausch Health Americas, Inc.

People needed

71

Starts

2018-09-13

Expected to finish

2020-03-12

Last updated by the study team

2023-04-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female age 18 to 75 years of age (inclusive) at the time of screening.
• 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.

You may not qualify if…

• Subject has an uncontrolled major psychiatric disorder including major depression or psychoses as determined by the investigator.
• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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