Summary:
Randomized, double blind, placebo controlled, dose ranging, study assessing efficacy and safety of rifaximin soluble solid dispersion tablets for the prevention of complications in subjects with early decompensated liver cirrhosis. Study is a total of 24 week treatment phase with a 2 week follow up period -- a total of 15 visits with 5 of them being phone visits.
Need documented cirrhosis with ascites (imaging study or physical exam) but none of the following:
- [EVB – clinically significant gastrointestinal bleed]
- [SBP – greater than 250 PMN cells/mm3 and/or + monomicrobial culture in the ascitic fluid]
- [Renal failure]
- [Development of medically refractory ascites; Must have MELD score ≥12 or Child Pugh score of 7-9]
Exclusion:
- HIV, variceal banding w/2 of screen and during study, and poorly controlled diabetes; Significant hypovolemia (or electrolyte abnormality), severe hypokalemia, anemic (Hb≤8 g/dL), renal insufficiency (creatinine≥10mg/dL)
- Intestinal obstruction or IBS
- Poorly controlled diabetes T1/T2
- Unstable cardiovascular or pulmonary disease
- Active malignancy within past 5 years; Varicella, herpes zoster, or other severe viral infection within 6 weeks of randomization
- HIV positive
- Positive stool tests for Yersinia entercolitica, Campylobacter jejuni, Salmonella, Shigella, ovum and parasites, and/or C. difficile
- Prohibited meds include milk thistle, lactulose (unless acute use), daily prophylactic antibiotics(some allowances), midodrine, and non-selective beta blockers for primary prophylactic treatment of small varices without criteria for increased risk of hemorrhage.
Sponsor allows for a designated care giver (if applicable) to receive compensation for bringing subjects to visits and being available for study phone calls; Subjects receive routine physicals, urinalysis, safety labs (CBC, Chem panel, Lipids PT/IN), MELD/Child Pugh scoring/assessment, and vital checks; all medications are provided for by Sponsor. Subjects will be paid a stipend ranging from $75-$15($650 ttl)/visit for subject and $15-$50($625 ttl)/visit for caregiver.