A Pilot Study of Xifaxan to Treat Patients With PSC
In the current protocol, we propose the assessment of potential beneficial effects of the antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15 adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or equal to 40 kg will receive Xifaxan, 550 mg twice daily.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis|
- Improvement in alkaline phosphatase [ Time Frame: Three months ] [ Designated as safety issue: No ]An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry
- Absence of treatment failure [ Time Frame: Three months ] [ Designated as safety issue: Yes ]Absence of treatment failure which is defined as any of the following: death, need for livertransplantation, side effects requiring discontinuation of therapy, worsening of liver biochemistries, voluntary discontinuation for any reason, marked worsening of fatigue or itching.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Xifaxan 550 mg two times per day for three months