Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
Condition: Overt Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Intervention: 40 mg Rifaximin SSD once daily; 40 mg Rifaximin SSD twice daily; 80 mg Rifaximin SSD once daily; 80 mg Rifaximin SSD twice daily; Placebo
Intervention description: SSD once daily (QD); SSD twice daily (BID); SSD once daily (QD); SSD twice daily (BID); Administered twice daily (BID)
Intervention MeSH terms: Rifaximin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Blinding will be maintained in the QD SSD cohorts by administering placebo as the second daily dose.
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

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).
    

Eligibility 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).