Overview

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

Status:
Completed
Trial end date:
2020-03-12
Target enrollment:
0
Participant gender:
All
Summary
Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bausch Health Americas, Inc.
Valeant Pharmaceuticals International, Inc.
Treatments:
Lactulose
Rifamycins
Rifaximin
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).